# Il-Ġurnal Uffiċjali C 295/2010

| | ISSN 1725-5198
  doi:10.3000/17255198.C_2010.295.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 295 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5329 ta' Ottubru 2010 |

ISSN 1725-5198

doi:10.3000/17255198.C_2010.295.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 295

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5329 ta' Ottubru 2010

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| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni Ewropea |
| 2010/C 295/01 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Lulju 2010 sa 31 Awwissu 2010 (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill) | 1 |
| 2010/C 295/02 | Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Lulju 2010 sa 31 Awwissu 2010 (Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE) | 17 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

2010/C 295/01

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Lulju 2010 sa 31 Awwissu 2010 (Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill

1

2010/C 295/02

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Lulju 2010 sa 31 Awwissu 2010 (Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE)

Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE

jew l-Artikolu 38 tad-Direttiva 2001/82/KE

17

| MT | |
| --- | --- |

MT

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IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET, KORPI, UFFIĊĊJI U AĠENZIJI TAL-UNJONI EWROPEA

Il-Kummissjoni Ewropea

| 29.10.2010 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 295/1 |
| --- | --- | --- | --- |

29.10.2010

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 295/1

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Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Lulju 2010 sa 31 Awwissu 2010

(Ippubblikat skont l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
   (1))

2010/C 295/01

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | INN
  (Denominazzjoni Internazzjonali Komuni) | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Forma farmaċewtika | Kodiċi ATC
  (Kodiċi Anatomiku Terapewtiku Kimiku) | Data ta' notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.7.2010 | Daxas | roflumilast | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/10/636/001-003 | Pillola miksija b’rita | R03DX07 | 8.7.2010 |
| 27.7.2010 | Leflunomide medac | leflunomide | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | EU/1/10/637/001-009 | Pillola miksija b’rita | L04AA13 | 30.7.2010 |
| 27.7.2010 | Ozurdex | Dexamethasone | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | EU/1/10/638/001 | Impjant intravitreali f’applikatur | S01BA01 | 1.8.2010 |
| 26.8.2010 | VPRIV | Velaglucerase alfa | Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646/001-002 | Trab għal soluzzjoni għall-infużjoni | A16AB10 | 30.8.2010 |
| 31.8.2010 | PecFent | Fentanyl | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | EU/1/10/644/001-004 | Sprej għall-imnieħer | N02AB03 | 6.9.2010 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

INN

(Denominazzjoni Internazzjonali Komuni)

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Forma farmaċewtika

Kodiċi ATC

(Kodiċi Anatomiku Terapewtiku Kimiku)

Data ta' notifika

5.7.2010

Daxas

roflumilast

Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/10/636/001-003

Pillola miksija b’rita

R03DX07

8.7.2010

27.7.2010

Leflunomide medac

leflunomide

medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland

EU/1/10/637/001-009

Pillola miksija b’rita

L04AA13

30.7.2010

27.7.2010

Ozurdex

Dexamethasone

Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland

EU/1/10/638/001

Impjant intravitreali f’applikatur

S01BA01

1.8.2010

26.8.2010

VPRIV

Velaglucerase alfa

Shire Pharmaceuticals Ireland Limited 5 Riverside Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646/001-002

Trab għal soluzzjoni għall-infużjoni

A16AB10

30.8.2010

31.8.2010

PecFent

Fentanyl

Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-004

Sprej għall-imnieħer

N02AB03

6.9.2010

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 1.7.2010 | Enbrel | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/126/001-021 | 6.7.2010 |
| 1.7.2010 | Humira | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 5.7.2010 |
| 1.7.2010 | Invega | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/07/395/001-095 | 6.7.2010 |
| 1.7.2010 | Kiovig | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | EU/1/05/329/001-006 | 5.7.2010 |
| 1.7.2010 | Mirapexin | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/001-006
  EU/1/97/051/009-033 | 5.7.2010 |
| 1.7.2010 | Orencia | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/07/389/001-003 | 5.7.2010 |
| 1.7.2010 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442/001-008 | 5.7.2010 |
| 1.7.2010 | Rapamune | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001
  EU/1/01/171/007-010 | 5.7.2010 |
| 1.7.2010 | Sifrol | Boehringer Ingelheim International GmbHBinger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/001-006
  EU/1/97/050/009-033 | 5.7.2010 |
| 1.7.2010 | Sutent | Pfizer LtdRamsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/06/347/001-008 | 5.7.2010 |
| 1.7.2010 | TachoSil | Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277/001-004 | 5.7.2010 |
| 1.7.2010 | Tarceva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311/001-003 | 5.7.2010 |
| 1.7.2010 | Taxotere | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | EU/1/95/002/001-005 | 5.7.2010 |
| 1.7.2010 | Tygacil | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/06/336/001 | 6.7.2010 |
| 1.7.2010 | Viagra | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/98/077/002-004
  EU/1/98/077/006-008
  EU/1/98/077/010-019 | 5.7.2010 |
| 2.7.2010 | ellaOne | Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France | EU/1/09/522/001 | 6.7.2010 |
| 2.7.2010 | Eucreas | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/425/001-018 | 7.7.2010 |
| 2.7.2010 | Galvus | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/414/001-010
  EU/1/07/414/018 | 7.7.2010 |
| 2.7.2010 | Intelence | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/468/001 | 7.7.2010 |
| 2.7.2010 | Jalra | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/485/001-011 | 7.7.2010 |
| 2.7.2010 | Myocet | Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France | EU/1/00/141/001 | 7.7.2010 |
| 2.7.2010 | NovoMix | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142/004-005
  EU/1/00/142/009-022 | 7.7.2010 |
| 2.7.2010 | Onglyza | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/09/545/001-010 | 7.7.2010 |
| 2.7.2010 | Pegasys | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221/001-010 | 7.7.2010 |
| 2.7.2010 | Sifrol | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/001-006
  EU/1/97/050/009-033 | 8.7.2010 |
| 2.7.2010 | Tamiflu | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222/001-004 | 7.7.2010 |
| 2.7.2010 | Tarceva | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311/001-003 | 7.7.2010 |
| 2.7.2010 | Torisel | Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom | EU/1/07/424/001 | 7.7.2010 |
| 2.7.2010 | Velcade | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274/001-002 | 6.7.2010 |
| 2.7.2010 | Xiliarx | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/486/001-011 | 7.7.2010 |
| 2.7.2010 | Xyrem | UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom | EU/1/05/312/001 | 6.7.2010 |
| 2.7.2010 | Zeffix | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/99/114/001-003 | 8.7.2010 |
| 2.7.2010 | Zyllt | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553/001-010 | 7.7.2010 |
| 5.7.2010 | Celvapan | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | EU/1/08/506/001 | 8.7.2010 |
| 5.7.2010 | Ferriprox | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/99/108/001-003 | 8.7.2010 |
| 5.7.2010 | Icandra | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/484/001-018 | 8.7.2010 |
| 5.7.2010 | Rebetol | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/107/001-005 | 13.7.2010 |
| 5.7.2010 | Relistor | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/08/463/001-003 | 8.7.2010 |
| 5.7.2010 | Reyataz | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267/001-010 | 8.7.2010 |
| 5.7.2010 | Thelin | Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | EU/1/06/353/001-005 | 8.7.2010 |
| 5.7.2010 | Zomarist | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/483/001-018 | 8.7.2010 |
| 6.7.2010 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 8.7.2010 |
| 6.7.2010 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | EU/1/07/384/001-005 | 8.7.2010 |
| 6.7.2010 | Keppra | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/00/146/001-032 | 9.7.2010 |
| 6.7.2010 | Rapamune | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/01/171/001
  EU/1/01/171/007-010
  EU/1/01/171/013-014 | 12.7.2010 |
| 6.7.2010 | Savene | TopoTarget A/S Fruebjergvej 3, Copenhagen 2100, Danmark | EU/1/06/350/001 | 12.7.2010 |
| 7.7.2010 | ReFacto AF | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/99/103/001-004 | 12.7.2010 |
| 13.7.2010 | BeneFIX | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 15.7.2010 |
| 13.7.2010 | Kepivance | Biovitrum AB (publ) SE-112 76 Stockholm, Sverige | EU/1/05/314/001 | 15.7.2010 |
| 22.7.2010 | Thelin | Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | EU/1/06/353/001-005 | 26.7.2010 |
| 27.7.2010 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343/001-007 | 29.7.2010 |
| 27.7.2010 | Conbriza | Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/09/511/001-004 | 29.7.2010 |
| 27.7.2010 | GONAL-f | Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001/001
  EU/1/95/001/003-005
  EU/1/95/001/009
  EU/1/95/001/012
  EU/1/95/001/021-022
  EU/1/95/001/025-028
  EU/1/95/001/031-035 | 30.7.2010 |
| 27.7.2010 | Iscover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/98/070/001a-001b
  EU/1/98/070/002a-002b
  EU/1/98/070/003a-003b
  EU/1/98/070/004a-004b
  EU/1/98/070/005a-005b
  EU/1/98/070/006a-006b
  EU/1/98/070/007a-007b
  EU/1/98/070/008-010
  EU/1/98/070/011a-011b
  EU/1/98/070/012 | 29.7.2010 |
| 27.7.2010 | MicardisPlus | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/02/213/013-016
  EU/1/02/213/020
  EU/1/02/213/022 | 29.7.2010 |
| 27.7.2010 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | EU/1/98/069/001a-001b
  EU/1/98/069/002a-002b
  EU/1/98/069/003a-003b
  EU/1/98/069/004a-004b
  EU/1/98/069/005a-005b
  EU/1/98/069/006a-006b
  EU/1/98/069/007a-007b
  EU/1/98/069/008-010
  EU/1/98/069/011a-011b
  EU/1/98/069/012 | 29.7.2010 |
| 27.7.2010 | Ribavirin Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/509/001-004 | 30.7.2010 |
| 27.7.2010 | Ribavirin Teva Pharma BV | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/527/001-016 | 31.7.2010 |
| 27.7.2010 | Zonegran | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/04/307/001-021 | 29.7.2010 |
| 28.7.2010 | Aranesp | Amgen Europe B.V.Minervum 7061, NL-4817 ZK Breda, Nederland Minervum | EU/1/01/185/001-022
  EU/1/01/185/031-099 | 2.8.2010 |
| 28.7.2010 | DaTSCAN | GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United KingdomGE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United KingdomGE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom | EU/1/00/135/001-002 | 2.8.2010 |
| 28.7.2010 | DuoCover | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/10/623/001-015 | 30.7.2010 |
| 28.7.2010 | Dynastat | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/02/209/001-008 | 2.8.2010 |
| 28.7.2010 | Erbitux | Merck KGaAFrankfurter Straße 250, 64271 Darmstadt, Deutschland | EU/1/04/281/001-005 | 2.8.2010 |
| 28.7.2010 | Fendrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgiquerue | EU/1/04/299/001-003 | 2.8.2010 |
| 28.7.2010 | Ferriprox | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/99/108/001-006 | 30.7.2010 |
| 28.7.2010 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/00/144/001-004 | 30.7.2010 |
| 28.7.2010 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145/001 | 30.7.2010 |
| 28.7.2010 | Increlex | Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France | EU/1/07/402/001 | 2.8.2010 |
| 28.7.2010 | Invanz | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216/001-002 | 2.8.2010 |
| 28.7.2010 | Invirase | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026/001-002 | 2.8.2010 |
| 28.7.2010 | Kaletra | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/01/172/001-007 | 2.8.2010 |
| 28.7.2010 | Kivexa | ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/04/298/001-003 | 2.8.2010 |
| 28.7.2010 | Kogenate Bayer | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/00/143/001-011 | 30.7.2010 |
| 28.7.2010 | Onsenal | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 30.7.2010 |
| 28.7.2010 | Prevenar 13 | Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique | EU/1/09/590/001-006 | 3.8.2010 |
| 28.7.2010 | Simponi | Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546/001-004 | 2.8.2010 |
| 28.7.2010 | Sprycel | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/363/001-011 | 2.8.2010 |
| 28.7.2010 | Tyverb | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/440/001-003 | 2.8.2010 |
| 6.8.2010 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom | EU/1/04/276/001-020
  EU/1/04/276/024-036 | 12.8.2010 |
| 6.8.2010 | Arava | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/99/118/001-010 | 10.8.2010 |
| 6.8.2010 | Byetta | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/06/362/001-004 | 10.8.2010 |
| 6.8.2010 | Cervarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419/001-012 | 10.8.2010 |
| 6.8.2010 | Crixivan | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/96/024/001-005
  EU/1/96/024/008
  EU/1/96/024/010 | 12.8.2010 |
| 6.8.2010 | DuoPlavin | Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France | EU/1/10/619/001-015 | 11.8.2010 |
| 6.8.2010 | Efficib | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457/001-016 | 11.8.2010 |
| 6.8.2010 | Evicel | OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200, B-1640 Rhode-St-Genèse/B-1640 Sint-Genesius-Rode, Belgique/België | EU/1/08/473/001-003 | 11.8.2010 |
| 6.8.2010 | Ferriprox | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | EU/1/99/108/001-006 | 10.8.2010 |
| 6.8.2010 | Grepid | Pharmathen S.A.6 Dervenakion, 15351 Pallini Attiki, Ελλάδα6 | EU/1/09/535/001-016 | 10.8.2010 |
| 6.8.2010 | Herceptin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/00/145/001 | 12.8.2010 |
| 6.8.2010 | Janumet | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455/001-016 | 11.8.2010 |
| 6.8.2010 | Januvia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383/001-018 | 12.8.2010 |
| 6.8.2010 | Karvea | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/97/049/001-039 | 10.8.2010 |
| 6.8.2010 | Karvezide | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/98/085/001-034 | 10.8.2010 |
| 6.8.2010 | Mepact | IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France | EU/1/08/502/001 | 13.8.2010 |
| 6.8.2010 | Mycamine | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | EU/1/08/448/001-002 | 10.8.2010 |
| 6.8.2010 | Naglazyme | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/05/324/001-002 | 10.8.2010 |
| 6.8.2010 | Olanzapine Mylan | Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475/001-034 | 10.8.2010 |
| 6.8.2010 | Rebif | Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-017 | 10.8.2010 |
| 6.8.2010 | Ristaben | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621/001-018 | 11.8.2010 |
| 6.8.2010 | Ristfor | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620/001-016 | 11.8.2010 |
| 6.8.2010 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France | EU/1/06/348/001-002 | 10.8.2010 |
| 6.8.2010 | Sildenafil ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603/001-015 | 11.8.2010 |
| 6.8.2010 | Suboxone | Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/06/359/001-004 | 10.8.2010 |
| 6.8.2010 | Sustiva | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110/001-005
  EU/1/99/110/008-010 | 10.8.2010 |
| 6.8.2010 | Velmetia | Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456/001-016 | 11.8.2010 |
| 6.8.2010 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382/001-018 | 10.8.2010 |
| 10.8.2010 | Trisenox | Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France | EU/1/02/204/001 | 12.8.2010 |
| 12.8.2010 | Celvapan | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | EU/1/08/506/001 | 13.8.2010 |
| 12.8.2010 | Focetria | Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia | EU/1/07/385/001-002
  EU/1/07/385/004 | 13.8.2010 |
| 12.8.2010 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/452/001 | 13.8.2010 |
| 16.8.2010 | Fosavance | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/310/001-009 | 18.8.2010 |
| 18.8.2010 | alli | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/401/007-011 | 24.8.2010 |
| 18.8.2010 | Binocrit | Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich | EU/1/07/410/001-026 | 20.8.2010 |
| 18.8.2010 | Epoetin alfa Hexal | Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411/001-026 | 20.8.2010 |
| 18.8.2010 | Gardasil | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/357/001-021 | 20.8.2010 |
| 18.8.2010 | IDflu | Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507/001-006 | 20.8.2010 |
| 18.8.2010 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/06/368/001-168 | 20.8.2010 |
| 18.8.2010 | Intanza | Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France | EU/1/08/505/001-006 | 20.8.2010 |
| 18.8.2010 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland | EU/1/09/604/001-010 | 20.8.2010 |
| 18.8.2010 | Neupro | Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland | EU/1/05/331/001-055 | 20.8.2010 |
| 18.8.2010 | Tesavel | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435/001-018 | 20.8.2010 |
| 23.8.2010 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | EU/1/97/046/001-039 | 24.8.2010 |
| 23.8.2010 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France | EU/1/98/086/001-034 | 24.8.2010 |
| 23.8.2010 | Silgard | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358/001-021 | 25.8.2010 |
| 26.8.2010 | Baraclude | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343/001-007 | 31.8.2010 |
| 26.8.2010 | Cayston | Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom | EU/1/09/543/001-002 | 31.8.2010 |
| 26.8.2010 | Cerezyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/97/053/001-005 | 30.8.2010 |
| 26.8.2010 | Cimzia | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/09/544/001-002 | 30.8.2010 |
| 26.8.2010 | Cubicin | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/328/001-004 | 31.8.2010 |
| 26.8.2010 | Docetaxel Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/611/001-002 | 31.8.2010 |
| 26.8.2010 | Elonva | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | EU/1/09/609/001-002 | 30.8.2010 |
| 26.8.2010 | Emtriva | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/03/261/001-003 | 31.8.2010 |
| 26.8.2010 | Hirobriz Breezhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | EU/1/09/594/001-010 | 31.8.2010 |
| 26.8.2010 | Kaletra | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/01/172/001-008 | 31.8.2010 |
| 26.8.2010 | Lyrica | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/04/279/001-044 | 31.8.2010 |
| 26.8.2010 | Mircera | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/07/400/001-024 | 31.8.2010 |
| 26.8.2010 | Myozyme | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/333/001-003 | 31.8.2010 |
| 26.8.2010 | Nexavar | Bayer Schering Pharma AG 13342 Berlin, Deutschland | EU/1/06/342/001 | 30.8.2010 |
| 26.8.2010 | Onbrez Breezhaler | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/593/001-010 | 31.8.2010 |
| 26.8.2010 | Osseor | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/04/287/001-006 | 31.8.2010 |
| 26.8.2010 | Pradaxa | Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442/001-008 | 30.8.2010 |
| 26.8.2010 | Prepandrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/453/002 | 31.8.2010 |
| 26.8.2010 | Privigen | CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | EU/1/08/446/001-006 | 31.8.2010 |
| 26.8.2010 | Protelos | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/04/288/001-006 | 31.8.2010 |
| 26.8.2010 | Revatio | Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/05/318/002 | 31.8.2010 |
| 26.8.2010 | Stalevo | Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi | EU/1/03/260/001-033 | 30.8.2010 |
| 26.8.2010 | Stelara | Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België | EU/1/08/494/001-004 | 30.8.2010 |
| 26.8.2010 | Tasigna | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/422/001-004 | 31.8.2010 |
| 26.8.2010 | Telzir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/04/282/001-002 | 31.8.2010 |
| 26.8.2010 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498/001-008 | 31.8.2010 |
| 26.8.2010 | Valdoxan | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/08/499/001-008 | 31.8.2010 |
| 26.8.2010 | Viramune | Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/055/001-004 | 30.8.2010 |
| 26.8.2010 | Zostavax | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/341/001-013 | 31.8.2010 |
| 31.8.2010 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412/001-026 | 2.9.2010 |
| 31.8.2010 | Actos | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/00/150/001-030 | 2.9.2010 |
| 31.8.2010 | Adenuric | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | EU/1/08/447/001-012 | 3.9.2010 |
| 31.8.2010 | Angiox | The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom | EU/1/04/289/002 | 7.9.2010 |
| 31.8.2010 | Ariclaim | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/283/008-012 | 3.9.2010 |
| 31.8.2010 | Arixtra | Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/02/206/001-035 | 2.9.2010 |
| 31.8.2010 | Avastin | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300/001-002 | 2.9.2010 |
| 31.8.2010 | Corlentor | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/317/001-014 | 2.9.2010 |
| 31.8.2010 | Glustin | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | EU/1/00/151/001-024 | 2.9.2010 |
| 31.8.2010 | HBVAXPRO | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France | EU/1/01/183/001
  EU/1/01/183/004-005
  EU/1/01/183/007-008
  EU/1/01/183/011
  EU/1/01/183/013
  EU/1/01/183/015
  EU/1/01/183/018-032 | 2.9.2010 |
| 31.8.2010 | Humira | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom | EU/1/03/256/001-010 | 3.9.2010 |
| 31.8.2010 | InductOs | Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/02/226/001 | 3.9.2010 |
| 31.8.2010 | Infanrix hexa | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/00/152/001-020 | 3.9.2010 |
| 31.8.2010 | Infanrix penta | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/00/153/001-010 | 3.9.2010 |
| 31.8.2010 | Isentress | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/436/001-002 | 6.9.2010 |
| 31.8.2010 | Ivemend | Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/437/001-004 | 2.9.2010 |
| 31.8.2010 | Procoralan | Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/316/001-014 | 2.9.2010 |
| 31.8.2010 | Truvada | Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom | EU/1/04/305/001-002 | 2.9.2010 |
| 31.8.2010 | Yentreve | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | EU/1/04/280/001-008 | 2.9.2010 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

1.7.2010

Enbrel

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/126/001-021

6.7.2010

1.7.2010

Humira

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

5.7.2010

1.7.2010

Invega

Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/07/395/001-095

6.7.2010

1.7.2010

Kiovig

Baxter AG Industriestraße 67, A - 1221 Wien, Österreich

EU/1/05/329/001-006

5.7.2010

1.7.2010

Mirapexin

Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/051/001-006

EU/1/97/051/009-033

5.7.2010

1.7.2010

Orencia

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/07/389/001-003

5.7.2010

1.7.2010

Pradaxa

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442/001-008

5.7.2010

1.7.2010

Rapamune

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001

EU/1/01/171/007-010

5.7.2010

1.7.2010

Sifrol

Boehringer Ingelheim International GmbHBinger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

5.7.2010

1.7.2010

Sutent

Pfizer LtdRamsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/06/347/001-008

5.7.2010

1.7.2010

TachoSil

Nycomed Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277/001-004

5.7.2010

1.7.2010

Tarceva

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

5.7.2010

1.7.2010

Taxotere

Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/95/002/001-005

5.7.2010

1.7.2010

Tygacil

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/06/336/001

6.7.2010

1.7.2010

Viagra

Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/98/077/002-004

EU/1/98/077/006-008

EU/1/98/077/010-019

5.7.2010

2.7.2010

ellaOne

Laboratoire HRA Pharma 15, rue Béranger, 75003 Paris, France

EU/1/09/522/001

6.7.2010

2.7.2010

Eucreas

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/425/001-018

7.7.2010

2.7.2010

Galvus

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

7.7.2010

2.7.2010

Intelence

Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/468/001

7.7.2010

2.7.2010

Jalra

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/485/001-011

7.7.2010

2.7.2010

Myocet

Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France

EU/1/00/141/001

7.7.2010

2.7.2010

NovoMix

Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142/004-005

EU/1/00/142/009-022

7.7.2010

2.7.2010

Onglyza

Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545/001-010

7.7.2010

2.7.2010

Pegasys

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/221/001-010

7.7.2010

2.7.2010

Sifrol

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/97/050/001-006

EU/1/97/050/009-033

8.7.2010

2.7.2010

Tamiflu

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/02/222/001-004

7.7.2010

2.7.2010

Tarceva

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/05/311/001-003

7.7.2010

2.7.2010

Torisel

Wyeth Europa Ltd Huntercombe Lane South, Taplow, Maidenhead, Berkshire SL6 0PH, United Kingdom

EU/1/07/424/001

7.7.2010

2.7.2010

Velcade

Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-002

6.7.2010

2.7.2010

Xiliarx

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/486/001-011

7.7.2010

2.7.2010

Xyrem

UCB Pharma Ltd. 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom

EU/1/05/312/001

6.7.2010

2.7.2010

Zeffix

Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/99/114/001-003

8.7.2010

2.7.2010

Zyllt

KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553/001-010

7.7.2010

5.7.2010

Celvapan

Baxter AG Industriestraße 67, A - 1221 Wien, Österreich

EU/1/08/506/001

8.7.2010

5.7.2010

Ferriprox

Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-003

8.7.2010

5.7.2010

Icandra

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/484/001-018

8.7.2010

5.7.2010

Rebetol

Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/99/107/001-005

13.7.2010

5.7.2010

Relistor

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/08/463/001-003

8.7.2010

5.7.2010

Reyataz

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/03/267/001-010

8.7.2010

5.7.2010

Thelin

Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom

EU/1/06/353/001-005

8.7.2010

5.7.2010

Zomarist

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/483/001-018

8.7.2010

6.7.2010

Avastin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

8.7.2010

6.7.2010

Docetaxel Winthrop

Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France

EU/1/07/384/001-005

8.7.2010

6.7.2010

Keppra

UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/00/146/001-032

9.7.2010

6.7.2010

Rapamune

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/01/171/001

EU/1/01/171/007-010

EU/1/01/171/013-014

12.7.2010

6.7.2010

Savene

TopoTarget A/S Fruebjergvej 3, Copenhagen 2100, Danmark

EU/1/06/350/001

12.7.2010

7.7.2010

ReFacto AF

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/99/103/001-004

12.7.2010

13.7.2010

BeneFIX

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/97/047/001-007

15.7.2010

13.7.2010

Kepivance

Biovitrum AB (publ) SE-112 76 Stockholm, Sverige

EU/1/05/314/001

15.7.2010

22.7.2010

Thelin

Encysive (UK) Limited Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom

EU/1/06/353/001-005

26.7.2010

27.7.2010

Baraclude

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

29.7.2010

27.7.2010

Conbriza

Wyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/09/511/001-004

29.7.2010

27.7.2010

GONAL-f

Merck Serono Europe Ltd. 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/95/001/001

EU/1/95/001/003-005

EU/1/95/001/009

EU/1/95/001/012

EU/1/95/001/021-022

EU/1/95/001/025-028

EU/1/95/001/031-035

30.7.2010

27.7.2010

Iscover

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/070/001a-001b

EU/1/98/070/002a-002b

EU/1/98/070/003a-003b

EU/1/98/070/004a-004b

EU/1/98/070/005a-005b

EU/1/98/070/006a-006b

EU/1/98/070/007a-007b

EU/1/98/070/008-010

EU/1/98/070/011a-011b

EU/1/98/070/012

29.7.2010

27.7.2010

MicardisPlus

Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/02/213/013-016

EU/1/02/213/020

EU/1/02/213/022

29.7.2010

27.7.2010

Plavix

Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France

EU/1/98/069/001a-001b

EU/1/98/069/002a-002b

EU/1/98/069/003a-003b

EU/1/98/069/004a-004b

EU/1/98/069/005a-005b

EU/1/98/069/006a-006b

EU/1/98/069/007a-007b

EU/1/98/069/008-010

EU/1/98/069/011a-011b

EU/1/98/069/012

29.7.2010

27.7.2010

Ribavirin Teva

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/509/001-004

30.7.2010

27.7.2010

Ribavirin Teva Pharma BV

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/527/001-016

31.7.2010

27.7.2010

Zonegran

Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

EU/1/04/307/001-021

29.7.2010

28.7.2010

Aranesp

Amgen Europe B.V.Minervum 7061, NL-4817 ZK Breda, Nederland Minervum

EU/1/01/185/001-022

EU/1/01/185/031-099

2.8.2010

28.7.2010

DaTSCAN

GE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United KingdomGE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United KingdomGE Healthcare Limited Little Chalfont, Bucks HP7 9NA, United Kingdom

EU/1/00/135/001-002

2.8.2010

28.7.2010

DuoCover

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/10/623/001-015

30.7.2010

28.7.2010

Dynastat

Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/02/209/001-008

2.8.2010

28.7.2010

Erbitux

Merck KGaAFrankfurter Straße 250, 64271 Darmstadt, Deutschland

EU/1/04/281/001-005

2.8.2010

28.7.2010

Fendrix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgiquerue

EU/1/04/299/001-003

2.8.2010

28.7.2010

Ferriprox

Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-006

30.7.2010

28.7.2010

Helixate NexGen

Bayer Schering Pharma AG 13342 Berlin, Deutschland

EU/1/00/144/001-004

30.7.2010

28.7.2010

Herceptin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145/001

30.7.2010

28.7.2010

Increlex

Ipsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, France

EU/1/07/402/001

2.8.2010

28.7.2010

Invanz

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/02/216/001-002

2.8.2010

28.7.2010

Invirase

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/96/026/001-002

2.8.2010

28.7.2010

Kaletra

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/01/172/001-007

2.8.2010

28.7.2010

Kivexa

ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/298/001-003

2.8.2010

28.7.2010

Kogenate Bayer

Bayer Schering Pharma AG 13342 Berlin, Deutschland

EU/1/00/143/001-011

30.7.2010

28.7.2010

Onsenal

Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

EU/1/03/259/001-006

30.7.2010

28.7.2010

Prevenar 13

Wyeth Lederle Vaccines S.A. Rue du Bosquet, 15 B-1348 Louvain-la-Neuve, Belgique

EU/1/09/590/001-006

3.8.2010

28.7.2010

Simponi

Centocor B.V. Einsteinweg 101, 2333 CB Leiden, Nederland

EU/1/09/546/001-004

2.8.2010

28.7.2010

Sprycel

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/363/001-011

2.8.2010

28.7.2010

Tyverb

Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/440/001-003

2.8.2010

6.8.2010

Abilify

Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom

EU/1/04/276/001-020

EU/1/04/276/024-036

12.8.2010

6.8.2010

Arava

Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland

EU/1/99/118/001-010

10.8.2010

6.8.2010

Byetta

Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/06/362/001-004

10.8.2010

6.8.2010

Cervarix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-012

10.8.2010

6.8.2010

Crixivan

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/96/024/001-005

EU/1/96/024/008

EU/1/96/024/010

12.8.2010

6.8.2010

DuoPlavin

Sanofi Pharma Bristol-Myers Squibb SNC 174 Avenue de France, F-75013 Paris, France

EU/1/10/619/001-015

11.8.2010

6.8.2010

Efficib

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/457/001-016

11.8.2010

6.8.2010

Evicel

OMRIX biopharmaceuticals S.A./N.V. 200 Chaussée de Waterloo/Waterloosesteenweg 200, B-1640 Rhode-St-Genèse/B-1640 Sint-Genesius-Rode, Belgique/België

EU/1/08/473/001-003

11.8.2010

6.8.2010

Ferriprox

Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland

EU/1/99/108/001-006

10.8.2010

6.8.2010

Grepid

Pharmathen S.A.6 Dervenakion, 15351 Pallini Attiki, Ελλάδα6

EU/1/09/535/001-016

10.8.2010

6.8.2010

Herceptin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/00/145/001

12.8.2010

6.8.2010

Janumet

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/455/001-016

11.8.2010

6.8.2010

Januvia

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383/001-018

12.8.2010

6.8.2010

Karvea

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/97/049/001-039

10.8.2010

6.8.2010

Karvezide

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/98/085/001-034

10.8.2010

6.8.2010

Mepact

IDM PHARMA SAS 11-15 Quai De Dion Bouton, 92816 Puteaux Cedex, France

EU/1/08/502/001

13.8.2010

6.8.2010

Mycamine

Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland

EU/1/08/448/001-002

10.8.2010

6.8.2010

Naglazyme

BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/05/324/001-002

10.8.2010

6.8.2010

Olanzapine Mylan

Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475/001-034

10.8.2010

6.8.2010

Rebif

Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/98/063/001-017

10.8.2010

6.8.2010

Ristaben

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/621/001-018

11.8.2010

6.8.2010

Ristfor

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/10/620/001-016

11.8.2010

6.8.2010

RotaTeq

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France

EU/1/06/348/001-002

10.8.2010

6.8.2010

Sildenafil ratiopharm

ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/603/001-015

11.8.2010

6.8.2010

Suboxone

Schering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België

EU/1/06/359/001-004

10.8.2010

6.8.2010

Sustiva

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/99/110/001-005

EU/1/99/110/008-010

10.8.2010

6.8.2010

Velmetia

Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/08/456/001-016

11.8.2010

6.8.2010

Xelevia

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382/001-018

10.8.2010

10.8.2010

Trisenox

Cephalon Europe 5 Rue Charles Martigny, 94700 Maisons Alfort, Cedex, France

EU/1/02/204/001

12.8.2010

12.8.2010

Celvapan

Baxter AG Industriestraße 67, A - 1221 Wien, Österreich

EU/1/08/506/001

13.8.2010

12.8.2010

Focetria

Novartis Vaccines and Diagnostics S.r.l. Via Fiorentina, 1, 53100 Siena, Italia

EU/1/07/385/001-002

EU/1/07/385/004

13.8.2010

12.8.2010

Pandemrix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/452/001

13.8.2010

16.8.2010

Fosavance

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/05/310/001-009

18.8.2010

18.8.2010

alli

Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/07/401/007-011

24.8.2010

18.8.2010

Binocrit

Sandoz GmbH Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/07/410/001-026

20.8.2010

18.8.2010

Epoetin alfa Hexal

Hexal AG. Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411/001-026

20.8.2010

18.8.2010

Gardasil

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/357/001-021

20.8.2010

18.8.2010

IDflu

Sanofi Pasteur SA 2, avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507/001-006

20.8.2010

18.8.2010

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland

EU/1/06/368/001-168

20.8.2010

18.8.2010

Intanza

Sanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, France

EU/1/08/505/001-006

20.8.2010

18.8.2010

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland

EU/1/09/604/001-010

20.8.2010

18.8.2010

Neupro

Schwarz Pharma Ltd Shannon, Industrial Estate, Co.Clare, Ireland

EU/1/05/331/001-055

20.8.2010

18.8.2010

Tesavel

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435/001-018

20.8.2010

23.8.2010

Aprovel

Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France

EU/1/97/046/001-039

24.8.2010

23.8.2010

CoAprovel

Sanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France - 75013 Paris, France

EU/1/98/086/001-034

24.8.2010

23.8.2010

Silgard

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/06/358/001-021

25.8.2010

26.8.2010

Baraclude

Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/06/343/001-007

31.8.2010

26.8.2010

Cayston

Gilead Sciences International Limited Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543/001-002

31.8.2010

26.8.2010

Cerezyme

Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/97/053/001-005

30.8.2010

26.8.2010

Cimzia

UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België

EU/1/09/544/001-002

30.8.2010

26.8.2010

Cubicin

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/328/001-004

31.8.2010

26.8.2010

Docetaxel Teva

Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland

EU/1/09/611/001-002

31.8.2010

26.8.2010

Elonva

N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland

EU/1/09/609/001-002

30.8.2010

26.8.2010

Emtriva

Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

EU/1/03/261/001-003

31.8.2010

26.8.2010

Hirobriz Breezhaler

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom

EU/1/09/594/001-010

31.8.2010

26.8.2010

Kaletra

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/01/172/001-008

31.8.2010

26.8.2010

Lyrica

Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom

EU/1/04/279/001-044

31.8.2010

26.8.2010

Mircera

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/07/400/001-024

31.8.2010

26.8.2010

Myozyme

Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/333/001-003

31.8.2010

26.8.2010

Nexavar

Bayer Schering Pharma AG 13342 Berlin, Deutschland

EU/1/06/342/001

30.8.2010

26.8.2010

Onbrez Breezhaler

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593/001-010

31.8.2010

26.8.2010

Osseor

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/287/001-006

31.8.2010

26.8.2010

Pradaxa

Boehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/08/442/001-008

30.8.2010

26.8.2010

Prepandrix

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/453/002

31.8.2010

26.8.2010

Privigen

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland

EU/1/08/446/001-006

31.8.2010

26.8.2010

Protelos

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/04/288/001-006

31.8.2010

26.8.2010

Revatio

Pfizer Limited Sandwich, Kent, CT13 9NJ, United Kingdom

EU/1/05/318/002

31.8.2010

26.8.2010

Stalevo

Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi

EU/1/03/260/001-033

30.8.2010

26.8.2010

Stelara

Janssen-Cilag International NV Turnhoutseweg, 30 - 2340 Beerse - België

EU/1/08/494/001-004

30.8.2010

26.8.2010

Tasigna

Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/422/001-004

31.8.2010

26.8.2010

Telzir

ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

EU/1/04/282/001-002

31.8.2010

26.8.2010

Thymanax

Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498/001-008

31.8.2010

26.8.2010

Valdoxan

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/08/499/001-008

31.8.2010

26.8.2010

Viramune

Boehringer Ingelheim International GmbH Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland

EU/1/97/055/001-004

30.8.2010

26.8.2010

Zostavax

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France

EU/1/06/341/001-013

31.8.2010

31.8.2010

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412/001-026

2.9.2010

31.8.2010

Actos

Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/00/150/001-030

2.9.2010

31.8.2010

Adenuric

Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/447/001-012

3.9.2010

31.8.2010

Angiox

The Medicines Company UK Ltd 115 L Milton Park, Abingdon, Oxfordshire, OX14 4SA, United Kingdom

EU/1/04/289/002

7.9.2010

31.8.2010

Ariclaim

Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/283/008-012

3.9.2010

31.8.2010

Arixtra

Glaxo Group Ltd. Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom

EU/1/02/206/001-035

2.9.2010

31.8.2010

Avastin

Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

EU/1/04/300/001-002

2.9.2010

31.8.2010

Corlentor

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/317/001-014

2.9.2010

31.8.2010

Glustin

Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom

EU/1/00/151/001-024

2.9.2010

31.8.2010

HBVAXPRO

Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, France

EU/1/01/183/001

EU/1/01/183/004-005

EU/1/01/183/007-008

EU/1/01/183/011

EU/1/01/183/013

EU/1/01/183/015

EU/1/01/183/018-032

2.9.2010

31.8.2010

Humira

Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-010

3.9.2010

31.8.2010

InductOs

Wyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom

EU/1/02/226/001

3.9.2010

31.8.2010

Infanrix hexa

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/001-020

3.9.2010

31.8.2010

Infanrix penta

GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/153/001-010

3.9.2010

31.8.2010

Isentress

Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/436/001-002

6.9.2010

31.8.2010

Ivemend

Merck Sharp & Dohme Limited Hertford Road, Hodderson, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/437/001-004

2.9.2010

31.8.2010

Procoralan

Les Laboratoires Servier 22, rue Garnier, 92200 Neuilly-sur-Seine, France

EU/1/05/316/001-014

2.9.2010

31.8.2010

Truvada

Gilead Sciences International Limited Cambridge CB21 6GT United Kingdom

EU/1/04/305/001-002

2.9.2010

31.8.2010

Yentreve

Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland

EU/1/04/280/001-008

2.9.2010

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 27.7.2010 | Osigraft | Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland | EU/1/01/179/001 | 29.7.2010 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

27.7.2010

Osigraft

Howmedica International S. de R.L. Division of Stryker Corporation, Raheen Industrial Estate, Raheen, Limerick, Ireland

EU/1/01/179/001

29.7.2010

—   Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 1.7.2010 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | EU/2/07/079/001-004 | 4.7.2010 |
| 1.7.2010 | Profender | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | EU/2/05/054/001-031 | 6.7.2010 |
| 1.7.2010 | Suprelorin | VIRBAC S.A.1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/07/072/001-004 | 5.7.2010 |
| 2.7.2010 | Cortavance | VIRBAC S.A.1ère Avenue 2065 m L.I.D. - 06516 Carros - France | EU/2/06/069/001 | 7.7.2010 |
| 2.7.2010 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/001
  EU/2/97/004/003-040 | 7.7.2010 |
| 5.7.2010 | Metacam | Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland | EU/2/97/004/001
  EU/2/97/004/003-042 | 7.7.2010 |
| 27.7.2010 | Equilis Prequenza | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/056/001-004 | 29.7.2010 |
| 27.7.2010 | Equilis Prequenza Te | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/057/001-004 | 29.7.2010 |
| 27.7.2010 | Equilis Te | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/05/055/001-002 | 29.7.2010 |
| 6.8.2010 | Fevaxyn Pentofel | Fort Dodge Laboratories Ireland Finisklin Industrial Estate - Sligo, Ireland | EU/2/96/002/001-003 | 12.8.2010 |
| 18.8.2010 | Zulvac 8 Bovis | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | EU/2/09/105/001-002 | 20.8.2010 |
| 18.8.2010 | Zulvac 8 Ovis | Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom | EU/2/09/104/001-002 | 20.8.2010 |
| 26.8.2010 | Advocate | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | EU/2/03/039/001-030 | 30.8.2010 |
| 26.8.2010 | Meloxidyl | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | EU/2/06/070/001-008 | 27.8.2010 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

1.7.2010

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland

EU/2/07/079/001-004

4.7.2010

1.7.2010

Profender

Bayer Animal Health GmbH 51368 Leverkusen, Deutschland

EU/2/05/054/001-031

6.7.2010

1.7.2010

Suprelorin

VIRBAC S.A.1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/07/072/001-004

5.7.2010

2.7.2010

Cortavance

VIRBAC S.A.1ère Avenue 2065 m L.I.D. - 06516 Carros - France

EU/2/06/069/001

7.7.2010

2.7.2010

Metacam

Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/001

EU/2/97/004/003-040

7.7.2010

5.7.2010

Metacam

Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim am Rhein, Deutschland

EU/2/97/004/001

EU/2/97/004/003-042

7.7.2010

27.7.2010

Equilis Prequenza

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/056/001-004

29.7.2010

27.7.2010

Equilis Prequenza Te

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/057/001-004

29.7.2010

27.7.2010

Equilis Te

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/05/055/001-002

29.7.2010

6.8.2010

Fevaxyn Pentofel

Fort Dodge Laboratories Ireland Finisklin Industrial Estate - Sligo, Ireland

EU/2/96/002/001-003

12.8.2010

18.8.2010

Zulvac 8 Bovis

Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom

EU/2/09/105/001-002

20.8.2010

18.8.2010

Zulvac 8 Ovis

Fort Dodge Animal Health Ltd Flanders Road, Hedge End, Southampton SO30 4QH, United Kingdom

EU/2/09/104/001-002

20.8.2010

26.8.2010

Advocate

Bayer Animal Health GmbH 51368 Leverkusen, Deutschland

EU/2/03/039/001-030

30.8.2010

26.8.2010

Meloxidyl

CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France

EU/2/06/070/001-008

27.8.2010

—   Ħruġ ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Miċħud

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 26.8.2010 | Masivet | AB Science S.A. 3 avenue George V, 75008 Paris, France | EU/2/08/087/001-002 | 31.8.2010 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

26.8.2010

Masivet

AB Science S.A. 3 avenue George V, 75008 Paris, France

EU/2/08/087/001-002

31.8.2010

—   Irtirar ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill)

| Data tad-deċiżjoni | Isem tal-prodott mediċinali | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-entrata fir-Reġistru Komunitarju | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 5.7.2010 | Nobilis Influenza H5N6 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/07/076/001-004 | 8.7.2010 |
| 7.7.2010 | Nobilis Influenza H7N1 | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/07/073/001-004 | 9.7.2010 |
| 22.7.2010 | Medicinal Oxygen Air Liquide Santé | Air Liquide Santé International 10 rue Cognacq-Jay, 75341 Paris Cedex 07, France | EU/2/06/067/001-002 | 26.7.2010 |

Data tad-deċiżjoni

Isem tal-prodott mediċinali

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-entrata fir-Reġistru Komunitarju

Data ta' notifika

5.7.2010

Nobilis Influenza H5N6

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/07/076/001-004

8.7.2010

7.7.2010

Nobilis Influenza H7N1

Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland

EU/2/07/073/001-004

9.7.2010

22.7.2010

Medicinal Oxygen Air Liquide Santé

Air Liquide Santé International 10 rue Cognacq-Jay, 75341 Paris Cedex 07, France

EU/2/06/067/001-002

26.7.2010

Kull min jixtieq jikkonsulta r-rapport ta' evalwazzjoni pubblika dwar il-prodotti mediċinali kkonċernati u d-deċiżjonijiet marbuta magħhom għandu jikkuntattja lil:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK - LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

---

(1)  ĠU L 136, 30.4.2004, p. 1.

---

| 29.10.2010 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 295/17 |
| --- | --- | --- | --- |

29.10.2010

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 295/17

---

Sommarju ta' deċiżjonijiet tal-Unjoni Ewropea dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti mediċinali minn 1 Lulju 2010 sa 31 Awwissu 2010

(Deċiżjonijiet meħuda skont l-Artikolu 34 tad-Direttiva 2001/83/KE
   (1)
  jew l-Artikolu 38 tad-Direttiva 2001/82/KE
   (2))

2010/C 295/02

—   Ħruġ, manteniment jew modifika ta' awtorizzazzjoni għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 16.8.2010 | Porcilis M Hyo and associated names | Ara l-Anness I | Ara l-Anness I | 17.8.2010 |
| 16.8.2010 | Porcilis PRRS and associated names | Ara l-Anness II | Ara l-Anness II | 17.8.2010 |
| 7.7.2010 | Levact and associated names | Ara l-Anness III | Ara l-Anness III | 9.7.2010 |
| 26.8.2010 | Valproic acid/valproate | Ara l-Anness IV | Ara l-Anness IV | 30.8.2010 |
| 1.7.2010 | Gadolinium | Ara l-Anness V | Ara l-Anness V | 5.7.2010 |
| 13.7.2010 | Valtrex and associated names | Ara l-Anness VI | Ara l-Anness VI | 16.7.2010 |
| 27.7.2010 | Famvir and associated names | Ara l-Anness VII | Ara l-Anness VII | 28.7.2010 |
| 7.7.2010 | Vascace | Ara l-Anness VIII | Ara l-Anness VIII | 8.7.2010 |
| 13.7.2010 | Atacand and associated names | Ara l-Anness IX | Ara l-Anness IX | 16.7.2010 |
| 1.7.2010 | Sortis | Ara l-Anness X | Ara l-Anness X | 6.7.2010 |
| 1.7.2010 | Quinolones and Fluoroquinolones | Ara l-Anness XI | Ara l-Anness XI | 6.7.2010 |
| 26.8.2010 | Seroquel XR and associated names | Ara l-Anness XII | Ara l-Anness XII | 30.8.2010 |
| 27.7.2010 | Tiamutin premix and associated names | Ara l-Anness XIII | Ara l-Anness XIII | 28.7.2010 |
| 5.7.2010 | Daxas | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri | 7.7.2010 |
| 27.7.2010 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, D-20354 Hamburg, Deutschland | Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri | 29.7.2010 |
| 27.7.2010 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri | 28.7.2010 |
| 1.7.2010 | Retacrit | HOSPIRA Enterprises B.V., Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland | Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri | 9.7.2010 |
| 1.7.2010 | Silapo | STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri | 5.7.2010 |
| 5.7.2010 | Thelin | Encysive (UK) Limited, Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri | 7.7.2010 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

16.8.2010

Porcilis M Hyo and associated names

Ara l-Anness I

Ara l-Anness I

17.8.2010

16.8.2010

Porcilis PRRS and associated names

Ara l-Anness II

Ara l-Anness II

17.8.2010

7.7.2010

Levact and associated names

Ara l-Anness III

Ara l-Anness III

9.7.2010

26.8.2010

Valproic acid/valproate

Ara l-Anness IV

Ara l-Anness IV

30.8.2010

1.7.2010

Gadolinium

Ara l-Anness V

Ara l-Anness V

5.7.2010

13.7.2010

Valtrex and associated names

Ara l-Anness VI

Ara l-Anness VI

16.7.2010

27.7.2010

Famvir and associated names

Ara l-Anness VII

Ara l-Anness VII

28.7.2010

7.7.2010

Vascace

Ara l-Anness VIII

Ara l-Anness VIII

8.7.2010

13.7.2010

Atacand and associated names

Ara l-Anness IX

Ara l-Anness IX

16.7.2010

1.7.2010

Sortis

Ara l-Anness X

Ara l-Anness X

6.7.2010

1.7.2010

Quinolones and Fluoroquinolones

Ara l-Anness XI

Ara l-Anness XI

6.7.2010

26.8.2010

Seroquel XR and associated names

Ara l-Anness XII

Ara l-Anness XII

30.8.2010

27.7.2010

Tiamutin premix and associated names

Ara l-Anness XIII

Ara l-Anness XIII

28.7.2010

5.7.2010

Daxas

Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri

7.7.2010

27.7.2010

Leflunomide medac

medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, D-20354 Hamburg, Deutschland

Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri

29.7.2010

27.7.2010

Ozurdex

Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland

Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri

28.7.2010

1.7.2010

Retacrit

HOSPIRA Enterprises B.V., Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland

Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri

9.7.2010

1.7.2010

Silapo

STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland

Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri

5.7.2010

5.7.2010

Thelin

Encysive (UK) Limited, Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom

Dawn id-Deċiżjonijiet huma indirizzati lill-Istati Membri

7.7.2010

—   Rifjut ta’ awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 22.7.2010 | Ciclosporin IDL | Ara l-Anness XIV | Ara l-Anness XIV | 29.7.2010 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

22.7.2010

Ciclosporin IDL

Ara l-Anness XIV

Ara l-Anness XIV

29.7.2010

—   Sospensjoni ta' awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 22.7.2010 | Ciclosporin IDL | Ara l-Anness XIV | Ara l-Anness XIV | 29.7.2010 |
| 6.8.2010 | Sibutramine | Ara l-Anness XV | Ara l-Anness XV | 10.8.2010 |
| 22.7.2010 | Tildren | Ara l-Anness XVI | Ara l-Anness XVI | 23.7.2010 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

22.7.2010

Ciclosporin IDL

Ara l-Anness XIV

Ara l-Anness XIV

29.7.2010

6.8.2010

Sibutramine

Ara l-Anness XV

Ara l-Anness XV

10.8.2010

22.7.2010

Tildren

Ara l-Anness XVI

Ara l-Anness XVI

23.7.2010

—   Revoka ta' awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-deċiżjoni | Isem/Ismijiet tal-prodott mediċinali | Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq | Stat Membru kkonċernat | Data ta' notifika |
| --- | --- | --- | --- | --- |
| 27.7.2010 | Bufexamac | Ara l-Anness XVII | Ara l-Anness XVII | 29.7.2010 |

Data tad-deċiżjoni

Isem/Ismijiet tal-prodott mediċinali

Detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq

Stat Membru kkonċernat

Data ta' notifika

27.7.2010

Bufexamac

Ara l-Anness XVII

Ara l-Anness XVII

29.7.2010

---

(1)  ĠU L 311, 28.11.2001, p. 67.

(2)  ĠU L 311, 28.11.2001, p. 1.

---

ANNESS I

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊJI TAL-ANNIMALI, METODU TA’AMMINISTRAZZJONI, ŻMIEN TA’ TIŻMIM, TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ MARKETING FL-ISTATI MEMBRI

| Stat Membru/EEA | Sid tal-awtorazzizjoni tal-kummerċ | Isem il-prodott | Qawwa | Għamla farmaċewtika | Speċji tal-annimali | Indikazzjonijiet | Żmien ta’tiżmim |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Awstrija | Intervet GmbH |
| Siemensstrasse 107 |
| 1210 Wien |
| Austria |

Stat Membru/EEA

Sid tal-awtorazzizjoni tal-kummerċ

Isem il-prodott

Qawwa

Għamla farmaċewtika

Speċji tal-annimali

Indikazzjonijiet

Żmien ta’tiżmim

Awstrija

Intervet GmbH

Siemensstrasse 107

1210 Wien

Austria

PORCILIS M HYO

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Belġjum

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M HYO

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Ċipru

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M. HYO

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Repubblika Ċeka

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M HYO

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Danimarka

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Estonja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Finlandja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Franza

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS Mhyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Ġermanja

| Intervet Deutschland GmbH |
| --- |
| Postfach 1130 |
| 85701 Unterschleißheim |
| Germany |

Intervet Deutschland GmbH

Postfach 1130

85701 Unterschleißheim

Germany

Porcilis M Hyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Greċja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M.Hyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Ungerija

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Irlanda

| Intervet Ireland Limited, |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited,

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Porcilis M Hyo, suspension for injection

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Italja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porsilis M-HYO

Ċellola sħiħa inattivata konċentrat tal-istrejn Mycoplasma hyopneumoniae 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Latvja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Litwanja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Lussemburgu

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M. Hyo, suspension injectable

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Malta

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Norveġja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

PORCILIS M HYO

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Polonja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores, n.o 16, |
| 2735–557 Agualva-Cacém |
| Portugal |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores, n.o 16,

2735–557 Agualva-Cacém

Portugal

Porcilis M hyo, suspensão para injecção

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Slovakkja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcillis M.Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Slovenja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Spainja

| POLIG. INDUSTRIAL EL MONTALVO, PARCELA 39 CARBAJOSA DE LA SAGRADA 37188 SALAMANCA |
| --- |
| Spain |

POLIG. INDUSTRIAL EL MONTALVO, PARCELA 39 CARBAJOSA DE LA SAGRADA 37188 SALAMANCA

Spain

PORCILIS Mhyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Swezja

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Olanda

| Intervet International bv |
| --- |
| Wim de Koerverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Intervet International bv

Wim de Koerverstraat 35

5831 AN Boxmeer

The Netherlands

Porcilis M Hyo

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

Renju Unit

Intervet International B.V. represented by

| Intervet UK Ltd |
| --- |
| Walton Manor |
| Walton |
| Milton Keynes |
| Bucks MK7 7AJ |

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Bucks MK7 7AJ

Porcilis M Hyo, suspension for injection

Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre

Suspensjoni għall-injezzjoni

Ħnieżer(ħnieżer imwaslla għall-qatla)

Għall-immunita'attiva għall-ħnieżer biex inaqqas feriti fil-pulmun minħabba infezzjoni kawżata Mycoplasma hyopneumoniae.

Xejn ġranet

---

ANNESS II

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊJI TAL-ANNIMALI, METODU TA' AMMINISTRAZZJONI, ŻMIEN TA’ TIŻMIM, TAS-SID TAL-AWTORIZZAZZJONI TAL-KUMMERĊ MARKETING FL-ISTATI MEMBRI

| Stat Membru/EEA | Sid tal-awtorazzizjoni tal-kummerċ | Product name | Isem il-prodott | Għamla farmaċewtika | Speċji tal-annimali | Indikazzjonijiet | Żmien ta’tiżmim |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Awstrija | Intervet GmbH |
| Siemensstrasse 107 |
| 1210 Wien |
| Austria |

Stat Membru/EEA

Sid tal-awtorazzizjoni tal-kummerċ

Product name

Isem il-prodott

Għamla farmaċewtika

Speċji tal-annimali

Indikazzjonijiet

Żmien ta’tiżmim

Awstrija

Intervet GmbH

Siemensstrasse 107

1210 Wien

Austria

Porcilis PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Belġjum

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Franza

| INTERVET |
| --- |
| RUE OLIVIER DE SERRES |
| ANGERS TECHNOPOLE |
| 49071 BEAUCOUZE |
| France |

INTERVET

RUE OLIVIER DE SERRES

ANGERS TECHNOPOLE

49071 BEAUCOUZE

France

PORCILIS PRRS IM

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Ġermanja

| Intervet Deutschland GmbH |
| --- |
| Postfach 1130 |
| 85701 Unterschleißheim |
| Germany |

Intervet Deutschland GmbH

Postfach 1130

85701 Unterschleißheim

Germany

Porcilis PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Greċja

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Irlanda

| Intervet Ireland Limited |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Porcilis PRRS IM

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Irlanda

| Intervet Ireland Limited |
| --- |
| Magna Drive |
| Magna Business Park |
| Citywest Road |
| Dublin 24 |
| Ireland |

Intervet Ireland Limited

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Ireland

Porcilis PRRS IDAL

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Italja

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Porsilis PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Lussemburgu

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Portugal

| Intervet Portugal – Saúde Animal, Lda |
| --- |
| Rua Agualva dos Açores, n.o 16, |
| 2735 – 557 Agualva-Cacém |
| Portugal |

Intervet Portugal – Saúde Animal, Lda

Rua Agualva dos Açores, n.o 16,

2735 – 557 Agualva-Cacém

Portugal

PORCILIS PRSS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Spanja

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRSS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Olanda

| Intervet International BV |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nederland |

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Porcilis PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

Renju Unit

| Intervet UK Ltd. |
| --- |
| Walton Manor, Walton |
| Milton Keynes, |
| Bucks MK7 7AJ |
| United Kingdom |

Intervet UK Ltd.

Walton Manor, Walton

Milton Keynes,

Bucks MK7 7AJ

United Kingdom

Porcilis PRRS

Strejn tal-vijrus ħajjin attenwati PRRSstrain DV: 104.0 - 106.3 TCID50 per dose

Lajofilisejt u solvent għall-suspensjoni għall-injezzjoni

Ħnieżer

Għall-immunita'attiva fi ħnieżer klinikament b’saħħithom f’ambjent kontaminat bil-PRRS vijrus, biex inaqqas l-infezzjonijiet virali ikkaġunati mill-istrejn Ewropej tal-vijrus PRRS

Xejn ġranet

---

ANNESS III

LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI FL-ISTATI MEMBRI

| Stat Membru UE/ZEE | L-Applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Astellas Pharma GmbH |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Stat Membru UE/ZEE

L-Applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Il-Belġju

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Id-Danimarka

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Ribomustin

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Il-Finlandja

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Ribomustin

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Franza

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Il-Ġermanja

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

L-Irlanda

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

L-Italja

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Ribomustin

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Il-Lussemburgu

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

In-Norveġja

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Il-Polonja

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Spanja

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Levact

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

Ir-Renju Unit

| Astellas Pharma GmbH |
| --- |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Il-Ġermanja |

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Il-Ġermanja

Ribomustin

2,5 mg/ml

Trab għal konċentrat għal soluzzjoni għal infużjoni

Użu għal ġol-vina

---

ANNESS IV

LISTA TAL-ISMIJIET, GHAMLIET FARMACEWTICI, QAWWA TAL-PRODOTTI MEDICINALI, MNEJN JINGHATA, DETENTURI TAL-AWTORIZZAZZJONI GHAT-TQEGHID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-Suq | Isem inventat | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Gerot Pharmazeutika G.m.b.H |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Stat Membru

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-Suq

Isem inventat

Qawwa

Għamla farmaċewtika

Mnejn jingħata

L-Awstrija

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 150 mg - Kapseln

150 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 200 mg - Kapseln

200 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 300 mg - Kapseln

300 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 300 mg - Filmtabletten

300 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 500 mg - Kapseln

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 50 mg/ml - Sirup für Kinder

50 mg/ml

mistura

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 300 mg/ml - Lösung zum Einnehmen

300 mg/ml

soluzzjoni orali

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 300 mg - Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| Gerot Pharmazeutika G.m.b.H |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

L-Awstrija

Convulex 500 mg - Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine chrono retard 300 mg - Filmtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine chrono retard 500 mg - Filmtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 500-1 000 mg/Dosis - Retardgranulat

500 -1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 50-200 mg/Dosis - Retardgranulat

50 - 200 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 50-350 mg/Dosis - Retardgranulat

50 - 350 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 100 mg - Retardgranulat in Beuteln

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 1 000 mg - Retardgranulat in Beuteln

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 250 mg - Retardgranulat in Beuteln

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 50 mg - Retardgranulat in Beuteln

50 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 500 mg - Retardgranulat in Beuteln

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine Chronosphere 750 mg - Retardgranulat in Beuteln

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine 300 mg - Filmtabletten

300 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| Sanofi-aventis GmbH |
| --- |
| SATURN Tower, |
| Leonard-Bernstein-Str. 10 |
| Vienna DC, A-1220 Wien |
| L-Awstrija |

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

L-Awstrija

Depakine 300 mg/ml - Tropfen

300 mg/ml

qtar orali, soluzzjoni

Użu orali

L-Awstrija

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-G. 3 |
| A-1140 Wien |
| L-Awstrija |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-G. 3

A-1140 Wien

L-Awstrija

Natriumvalproat “ratiopharm” retard 300 mg - Filmtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| Ratiopharm Arzneimittel Vertriebs-GmbH |
| --- |
| Albert-Schweitzer-G. 3 |
| A-1140 Wien |
| L-Awstrija |

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-G. 3

A-1140 Wien

L-Awstrija

Natriumvalproat “ratiopharm” retard 500 mg - Filmtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

L-Awstrija

Natriumvalproat G.L. 300 mg - Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| G. L. Pharma GmbH |
| --- |
| Schloßplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

L-Awstrija

Natriumvalproat G.L. 500 mg - Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Il-Belġju |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Il-Belġju

CONVULEX

50 mg/ml

mistura

Użu orali

Il-Belġju

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Il-Belġju |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Il-Belġju

CONVULEX 300

300 mg

kapsula gastro-reżistenti, iebsa

Użu orali

Il-Belġju

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Il-Belġju |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Il-Belġju

CONVULEX 500

500 mg

kapsula gastro-reżistenti, iebsa

Użu orali

Il-Belġju

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Il-Belġju |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Il-Belġju

CONVULEX-150

150 mg

kapsula gastro-reżistenti, iebsa

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE

300 mg/ml

qtar orali, soluzzjoni

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE 300 MG/5 ML

300 mg/5 ml

mistura

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE CHRONO 300

200,00 mg/87,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE CHRONO 500

333,00 mg/145,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE CHRONO MICROGRANULES 0,33G/G

220,00 mg/g/96,00 mg/g

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE ENTERIC 150

150 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE ENTERIC 300

300 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKINE ENTERIC 500

500 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKOTE 250

269,10 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAKOTE 500

538,20 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

DEPAMIDE

300 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade b22 |
| 1020 Laken |
| Il-Belġju |

EUROGENERICS N.V.

Heizel Esplanade b22

1020 Laken

Il-Belġju

VALPROATE RETARD EG 300 MG

200,00 mg/87,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade b22 |
| 1020 Laken |
| Il-Belġju |

EUROGENERICS N.V.

Heizel Esplanade b22

1020 Laken

Il-Belġju

VALPROATE RETARD EG 500 MG

333,00 mg/145,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Il-Belġju |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Il-Belġju

VALPROATE RETARD MYLAN 300 MG

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Il-Belġju |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Il-Belġju

VALPROATE RETARD MYLAN 500 MG

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Il-Belġju |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Il-Belġju

VALPROATE SANDOZ 300 MG

199,80 mg/87,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANDOZ N.V. |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Il-Belġju |

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Il-Belġju

VALPROATE SANDOZ 500 MG

333,00 mg/145,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

VALPROIM CHRONO 300

200,00 mg/87,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

VALPROIM CHRONO 500

333,00 mg/145,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

VALPROIM LA 300

300,00 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| SANOFI-AVENTIS BELGIUM N.V. |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Il-Belġju |

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Il-Belġju

VALPROIM LA 500

500,00 mg

pillola gastro-reżistenti

Użu orali

Il-Belġju

| Kristina De Turck |
| --- |
| KDT Consulting |
| Chaussée de Ninove 2 |
| 1540 Herne |
| Il-Belġju |

Kristina De Turck

KDT Consulting

Chaussée de Ninove 2

1540 Herne

Il-Belġju

VALPROSTAT 300 MG

199,80 mg/87,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| Kristina De Turck |
| --- |
| KDT Consulting |
| Chaussée de Ninove 2 |
| 1540 Herne |
| Il-Belġju |

Kristina De Turck

KDT Consulting

Chaussée de Ninove 2

1540 Herne

Il-Belġju

VALPROSTAT 500 MG

333,00 mg/145,00 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Bulgarija

| AWD. pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Il-Ġermanja |

AWD. pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Il-Ġermanja

Convulsofin

333 mg

pillola

Użu orali

Il-Bulgarija

| G.L.Pharma GmbH Schlossplatz 1, |
| --- |
| A-8502 Lannach, |
| L-Awstrija |

G.L.Pharma GmbH Schlossplatz 1,

A-8502 Lannach,

L-Awstrija

Convulex chrono

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Bulgarija

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| L-Awstrija |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

L-Awstrija

Convulex chrono

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Bulgarija

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| L-Awstrija |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

L-Awstrija

Convulex

500 mg

kapsula gastro-reżistenti

Użu orali

Il-Bulgarija

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| L-Awstrija |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

L-Awstrija

Convulex

150 mg

kapsula gastro-reżistenti

Użu orali

Il-Bulgarija

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| L-Awstrija |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

L-Awstrija

Convulex

300 mg

kapsula gastro-reżistenti

Użu orali

Il-Bulgarija

| G.L.Pharma GmbH Schlossplatz 1 |
| --- |
| A-8502 Lannach |
| L-Awstrija |

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

L-Awstrija

Convulex

50 mg/ml

mistura

Użu orali

Il-Bulgarija

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Il-Bulgarija |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Il-Bulgarija

Depakine Chrono

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Bulgarija

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Il-Bulgarija |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Il-Bulgarija

Depakine Chrono

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Bulgarija

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Il-Bulgarija |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Il-Bulgarija

Depakine

5,764 g/100 ml

mistura

Użu orali

Il-Bulgarija

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Il-Bulgarija |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Il-Bulgarija

Depakine

200 mg

pillola gastro-reżistenti

Użu orali

Il-Bulgarija

| Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България |
| --- |
| Il-Bulgarija |

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Il-Bulgarija

Depakine

500 mg

pillola gastro-reżistenti

Użu orali

Il-Bulgarija

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Bulgarija

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Bulgarija

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Bulgarija

Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България

Depakine chronosphere

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONO

500 mg

pillola

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONOSPHERE

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONOSPHERE

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONOSPHERE

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONOSPHERE

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONOSPHERE

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Sanofi-Aventis Cyprus Ltd |
| --- |
| Charalambou |
| Mouskou 14 |
| 2015 Strovolos |
| Ċipru |

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Ċipru

DEPAKINE CHRONOSPHERE

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ċipru

| Remedica Ltd |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Ċipru |

Remedica Ltd

Aharnon street

P.O.Box 51706

3508 Lemesos

Ċipru

PETILIN

500 mg

pillola gastro-reżistenti

Użu orali

Ċipru

| Remedica Ltd |
| --- |
| Aharnon street |
| P.O.Box 51706 |
| 3508 Lemesos |
| Ċipru |

Remedica Ltd

Aharnon street

P.O.Box 51706

3508 Lemesos

Ċipru

PETILIN

200 mg/5 ml

mistura

Użu orali

Ir-Repubblika Ċeka

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Absenor 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Absenor 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Ir-Repubblika Ċeka |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Ir-Repubblika Ċeka

DEPAKINE

5,764 /100 ml

mistura

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX 300 mg/ml

300 mg/1 ml of drops

qtar orali, soluzzjoni

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX

50 mg/ml

mistura

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX CR 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX CR 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX 150

150 mg

kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX 300

300 mg

kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

| G.L. Pharma GmbH |
| --- |
| Schlossplatz 1 |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX 500

500 mg

kapsula, ratba

Użu orali

Ir-Repubblika Ċeka

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Ir-Repubblika Ċeka |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Ir-Repubblika Ċeka

DEPAKINE CHRONO 500 mg sécable

500 mg (333 mg/145 mg)

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Repubblika Ċeka

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Ir-Repubblika Ċeka |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Ir-Repubblika Ċeka

DEPAKINE CHRONO 300 mg sécable

300 mg (199,8 mg/87 mg)

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril 150

150 mg

pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril 300

300 mg

pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril 600

600 mg

pillola gastro-reżistenti

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril long 150 mg

150 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril long 300 mg

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril long 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

Orfiril long 1 000 mg

1 000 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| SANDOZ GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| L-Awstrija |

SANDOZ GmbH

Biochemiestrasse 10

A-6250 Kundl

L-Awstrija

Valproat Chrono Sandoz 300 mg

300 mg

(200 mg/87 mg)

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| SANDOZ GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| L-Awstrija |

SANDOZ GmbH

Biochemiestrasse 10

A-6250 Kundl

L-Awstrija

Valproat Chrono Sandoz 500 mg

500 mg

(333 mg/145 mg)

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| sanofi-aventis, s.r.o. |
| --- |
| Hadovka Office Park |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Ir-Repubblika Ċeka |

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Ir-Repubblika Ċeka

DEPAKINE CHRONOSPHERE 500 MG

500 mg

(333,30 mg/145,14 mg)

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Repubblika Ċeka

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Il-Ġermanja

Valproat-ratiopharm Chrono 300 mg

300 mg

(200 mg/87 mg)

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Repubblika Ċeka

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Il-Ġermanja

Valproat-ratiopharm Chrono 500 mg

500 mg

(333 mg/145 mg)

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine

100 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine

300 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine

500 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine

200 mg/ml

qtar orali

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine

60 mg/ml

soluzzjoni orali

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine Retard

300 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Sanofi-aventis Denmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Id-Danimarka |

Sanofi-aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Id-Danimarka

Deprakine Retard

500 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril

60 mg/ml

soluzzjoni orali

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril

300 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril

600 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril Long

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril Long

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril Long

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril Long

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Id-Danimarka

| Desitin Arzneimittel Gmbh |
| --- |
| Weg beim Jaeger 214 |
| DE-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Il-Ġermanja

Orfiril Retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Id-Danimarka |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Id-Danimarka

Valproat “Hexal”

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| HEXAL A/S |
| --- |
| Kanalholmen 8-12 |
| DK-2650 Hvidovre |
| Id-Danimarka |

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Id-Danimarka

Valproat “Hexal”

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Id-Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Id-Danimarka

Valproat “Sandoz”

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Sandoz A/S |
| --- |
| Edvard Thomsens Vej 14 |
| DK-2300 København S |
| Id-Danimarka |

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Id-Danimarka

Valproat “Sandoz”

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine

300 mg

pillola

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine

100 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine

300 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine

500 mg

pillola gastro-reżistenti

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine

200 mg/ml

qtar orali, soluzzjoni

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine Retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine Retard

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Delepsine

60 mg/ml

soluzzjoni orali

Użu orali

L-Estonja

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintie 1 |
| 02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Il-Finlandja

ABSENOR

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintie 1 |
| 02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Il-Finlandja

ABSENOR

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

50 mg/ml

mistura

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 150 MG

150 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 300 MG

300 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 300 MG/ML

300 mg/ml

qtar orali, soluzzjoni

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH, |
| --- |
| Arnethgasse 3 |
| A-1160 Wien, |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH,

Arnethgasse 3

A-1160 Wien,

L-Awstrija

CONVULEX 500 MG

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX RETARD 300 MG

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX RETARD 500 MG

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| L-Estonja |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

L-Estonja

DEPAKINE

50 mg/1 ml

mistura

Użu orali

L-Estonja

| Sanofi-Aventis Estonia OÜ, |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| L-Estonja |

Sanofi-Aventis Estonia OÜ,

Pärnu mnt 139E/2

11317 Tallinn

L-Estonja

DEPAKINE CHRONO 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| L-Estonja |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

L-Estonja

DEPAKINE CHRONO 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| L-Estonja |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

L-Estonja

DEPAKINE CHRONOSPHERE

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Estonja

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| L-Estonja |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

L-Estonja

DEPAKINE CHRONOSPHERE

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Estonja

| Sanofi-Aventis Estonia OÜ |
| --- |
| Pärnu mnt 139E/2 |
| 11317 Tallinn |
| L-Estonja |

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

L-Estonja

DEPAKINE CHRONOSPHERE

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL 150

150 mg

pillola gastro-reżistenti

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL 300

300 mg

pillola gastro-reżistenti

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL 600

600 mg

pillola gastro-reżistenti

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 1 000 MG

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 150 MG

150 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg, |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg,

Il-Ġermanja

ORFIRIL LONG 300 MG

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH, |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 500 MG

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Estonja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Il-Ġermanja

ORFIRIL SAFT

60 mg/ml

soluzzjoni orali

Użu orali

L-Estonja

| STADA ARZNEIMITTEL AG |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Il-Ġermanja |

STADA ARZNEIMITTEL AG

Stadastr. 2-18

D-61118 Bad Vilbel

Il-Ġermanja

PRODEPA

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Is-Slovenja

VALPROATE SODIUM SANDOZ 300 MG

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Estonja

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Is-Slovenja

VALPROATE SODIUM SANDOZ 500 MG

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

100 mg/dose

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

1 000 mg/dose

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

250 mg/dose

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

500 mg/dose

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

100 mg

pillola gastro-reżistenti

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

300 mg

pillola gastro-reżistenti

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

500 mg

pillola gastro-reżistenti

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

60 mg/ml

soluzzjoni orali

Użu orali

Il-Finlandja

| sanofi-aventis Oy |
| --- |
| Huopalahdentie 24 |
| B.O. Box 22 |
| FI-00351 Helsinki |
| Il-Finlandja |

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Il-Finlandja

DEPRAKINE

200 mg/ml

qtar orali, soluzzjoni

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

100 mg

pillola gastro-reżistenti

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

300 mg

pillola gastro-reżistenti

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

500 mg

pillola gastro-reżistenti

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

60 mg/ml

soluzzjoni orali

Użu orali

Il-Finlandja

| Orion Oyj |
| --- |
| Orionintie 1 |
| B.O. Box 65 |
| FI-02201 Espoo |
| Il-Finlandja |

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Il-Finlandja

ABSENOR

200 mg/ml

qtar orali, soluzzjoni

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

NATRIUMVALPRO-AATTI LONG DESITIN

150 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

NATRIUMVALPRO-AATTI LONG DESITIN

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

NATRIUMVALPRO-AATTI LONG DESITIN

1 000 mg/dose

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

NATRIUMVALPRO-AATTI LONG DESITIN

500 mg/dose

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL

60 mg/ml

soluzzjoni orali

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG

150 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Finlandja

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40, 5220 Odense SØ Id-Danimarka |

Sandoz A/S

C.F. Tietgens Boulevard 40, 5220 Odense SØ Id-Danimarka

VALPROAT SANDOZ

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| Sandoz A/S |
| --- |
| C.F. Tietgens Boulevard 40, 5220 Odense SØ Id-Danimarka |

Sandoz A/S

C.F. Tietgens Boulevard 40, 5220 Odense SØ Id-Danimarka

VALPROAT SANDOZ

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE

200 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE

500 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE

200 mg/ml

soluzzjoni orali

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONO

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE

57,64 mg/ml

mistura

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAMIDE

300 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKOTE

125 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKOTE

250 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKOTE

500 mg

pillola gastro-reżistenti

Użu orali

Franza

| VENIPHARM |
| --- |
| 4, BUREAUX DE LA COLLINE |
| 92213 SAINT-CLOUD |
| Franza |

VENIPHARM

4, BUREAUX DE LA COLLINE

92213 SAINT-CLOUD

Franza

IMASLAV LP

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

50 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

MICROPAKINE LP

0,33 g/g

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| ALTER |
| --- |
| 3, avenue de la Baltique |
| 91140 Villebon Sur Yvette |
| Franza |

ALTER

3, avenue de la Baltique

91140 Villebon Sur Yvette

Franza

VALPROATE DE SODIUM ALTER L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| ARROW GENERIQUES |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| Franza |

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Franza

VALPROATE DE SODIUM ARROW L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| BIOGARAN |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| Franza |

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Franza

VALPROATE DE SODIUM BIOGARAN L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret FRANZA |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret FRANZA

VALPROATE DE SODIUM GNR LP

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| “Le Quintet” - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Franza |

EG LABO - LABORATOIRES EUROGENERICS

“Le Quintet” - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Franza

VALPROATE DE SODIUM EG L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM DAKOTA PHARM,

200 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM DAKOTA PHARM,

500 mg

pillola gastro-reżistenti

Użu orali

Franza

| MYLAN SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Franza |

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Franza

VALPROATE DE SODIUM MYLAN L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| QUALIMED (LYON) |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| Franza |

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

Franza

VALPROATE DE SODIUM QUALIMED L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| RATIOPHARM (ALLEMAGNE) |
| --- |
| Graf Arco Strasse 3 |
| 89079 Ulm |
| Il-Ġermanja |

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Il-Ġermanja

VALPROATE DE SODIUM RATIOPHARM L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| RANBAXY PHARMACIE GENERIQUES |
| --- |
| 11-15 Quai Dion Bouton |
| 92800 Puteaux |
| Franza |

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Franza

VALPROATE DE SODIUM RPG L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANDOZ |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| Franza |

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Franza

VALPROATE DE SODIUM SANDOZ L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| TEVA CLASSICS |
| --- |
| Le Palatin 1 |
| 92936 Paris la Défense Cedex |
| Franza |

TEVA CLASSICS

Le Palatin 1

92936 Paris la Défense Cedex

Franza

VALPROATE DE SODIUM TEVA L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM WINTHROP

20 %

soluzzjoni orali

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM WINTHROP

200 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM WINTHROP

500 mg

pillola gastro-reżistenti

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM WINTHROP L.P.

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

50 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

50 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Franza

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Franza

VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P.

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Il-Ġermanja |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Il-Ġermanja

CONVULEX 150

150 mg

kapsula gastro-reżistenti

Użu orali

Il-Ġermanja

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Il-Ġermanja |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Il-Ġermanja

Convulex 300

300 mg

kapsula gastro-reżistenti

Użu orali

Il-Ġermanja

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Il-Ġermanja |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Il-Ġermanja

Convulex 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Il-Ġermanja |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Il-Ġermanja

Convulex 500

500 mg

kapsula gastro-reżistenti

Użu orali

Il-Ġermanja

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Il-Ġermanja |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Il-Ġermanja

Convulex 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Il-Ġermanja |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Il-Ġermanja

Convulex Tropflösung

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Il-Ġermanja |

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Il-Ġermanja

Convulsofin Tabletten

500 mg

pillola

Użu orali

Il-Ġermanja

| Steiner & Co. |
| --- |
| Ostpreussendamm 72-74 |
| D-12207 Berlin |
| Il-Ġermanja |

Steiner & Co.

Ostpreussendamm 72-74

D-12207 Berlin

Il-Ġermanja

Convulsofin-Tropfen

30 g

qtar orali, soluzzjoni

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl 500 mg

500 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl chrono 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl chrono 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Chronosphere 100 mg Retardgranulat

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Chronosphere 1 000 mg Retardgranulat

1 000,6 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Chronosphere 250 mg Retardgranulat

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Chronosphere 50 mg Retardgranulat

50 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Chronosphere 500 mg Retardgranulat

500,3 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Chronosphere 750 mg Retardgranulat

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sanofi-Aventis Deutschland GmbH |
| --- |
| Industriepark Höchst, Gebäude K703 |
| D-65926 Frankfurt am Main |
| Il-Ġermanja |

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Il-Ġermanja

Ergenyl Lösung

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Il-Ġermanja |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Il-Ġermanja

espa-valept 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Il-Ġermanja |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Il-Ġermanja

espa-valept 300 mg retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Il-Ġermanja |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Il-Ġermanja

espa-valept 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Il-Ġermanja |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Il-Ġermanja

espa-valept 500 mg retard

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Il-Ġermanja |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Il-Ġermanja

espa-valept 600 mg

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dolorgiet GmbH & Co. |
| --- |
| Postfach 1252 |
| D-53730 St.Augustin |
| Il-Ġermanja |

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Il-Ġermanja

Leptilan 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dolorgiet GmbH & Co. |
| --- |
| Postfach 1252 |
| D-53730 St.Augustin |
| Il-Ġermanja |

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Il-Ġermanja

Leptilan 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dolorgiet GmbH & Co. |
| --- |
| Postfach 1252 |
| D-53730 St.Augustin |
| Il-Ġermanja |

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Il-Ġermanja

Leptilan 600 mg

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Natriumvalproat Desitin retard 1 000 mg

1 000 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Natriumvalproat Desitin retard 150 mg

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Natriumvalproat Desitin retard 300 mg

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Natriumvalproat Desitin retard 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril 150

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril 200 mg

200 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril 300

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril 500 mg

500 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril 600

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril long 1 000 mg

1 000 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril long 150 mg

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril long 300 mg

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril long 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Orfiril Saft

60 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valberg PR 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valberg PR 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valdia PR 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valdia PR 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valhel PR 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valhel PR 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| ALIUD PHARMA GmbH |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |
| Il-Ġermanja |

ALIUD PHARMA GmbH

Postfach 1380

D-89146 Laichingen

Il-Ġermanja

Valpro AL 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| ALIUD PHARMA GmbH |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |
| Il-Ġermanja |

ALIUD PHARMA GmbH

Postfach 1380

D-89146 Laichingen

Il-Ġermanja

Valpro AL 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Il-Ġermanja |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Il-Ġermanja

Valpro beta

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Il-Ġermanja |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Il-Ġermanja

Valpro beta 150

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Il-Ġermanja |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Il-Ġermanja

Valpro beta 300

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Il-Ġermanja |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Il-Ġermanja

Valpro beta 600

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Il-Ġermanja |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Il-Ġermanja

Valpro beta chrono 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Il-Ġermanja |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Il-Ġermanja

Valpro beta chrono 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Il-Ġermanja |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Il-Ġermanja

Valpro TAD 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Il-Ġermanja |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Il-Ġermanja

Valpro TAD 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Il-Ġermanja |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Il-Ġermanja

Valpro TAD 600 mg

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Il-Ġermanja |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Il-Ġermanja

Valpro TAD chrono 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Il-Ġermanja |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Il-Ġermanja

Valpro TAD chrono 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Il-Ġermanja |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Il-Ġermanja

Valpro TAD Lösung

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Il-Ġermanja |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Il-Ġermanja

Valproat AbZ 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AbZ-Pharma GmbH |
| --- |
| Dr. Georg-Spohn-Str. 7 |
| D-89143 Blaubeuren |
| Il-Ġermanja |

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Il-Ġermanja

Valproat AbZ 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Il-Ġermanja |

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Il-Ġermanja

Valproat AWD 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AWD.pharma GmbH & Co. KG |
| --- |
| Wasastr. 50 |
| D-01445 Radebeul |
| Il-Ġermanja |

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Il-Ġermanja

Valproat AWD 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Valproat chrono Desitin 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Il-Ġermanja

Valproat chrono Desitin 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Il-Ġermanja |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Il-Ġermanja

Valproat Chrono Winthrop 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Il-Ġermanja |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Il-Ġermanja

Valproat Chrono Winthrop 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Il-Ġermanja |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Il-Ġermanja

Valproat chrono-CT 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Il-Ġermanja |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Il-Ġermanja

Valproat chrono-CT 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Il-Ġermanja |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Il-Ġermanja

Valproat Heumann chrono 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Heumann Pharma GmbH & Co. Generica KG |
| --- |
| Südwestpark 50 |
| D-90449 Nürnberg |
| Il-Ġermanja |

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Il-Ġermanja

Valproat Heumann chrono 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Il-Ġermanja |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Il-Ġermanja

Valproat HEXAL 150 mg Filmtabletten

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Il-Ġermanja |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Il-Ġermanja

Valproat HEXAL 300 mg Filmtabletten

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Il-Ġermanja |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Il-Ġermanja

Valproat HEXAL 300 mg/ml Lösung

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Il-Ġermanja |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Il-Ġermanja

Valproat HEXAL 600 mg Filmtabletten

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Il-Ġermanja |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Il-Ġermanja

Valproat HEXAL chrono 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Il-Ġermanja |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Il-Ġermanja

Valproat HEXAL chrono 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Orion Corporation |
| --- |
| Postfach P.O. Box 65 |
| FIN-02101 ESPOO |
| Il-Finlandja |

Orion Corporation

Postfach P.O. Box 65

FIN-02101 ESPOO

Il-Finlandja

Valproat Orion 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Orion Corporation |
| --- |
| Postfach P.O. Box 65 |
| FIN-02101 ESPOO |
| Il-Finlandja |

Orion Corporation

Postfach P.O. Box 65

FIN-02101 ESPOO

Il-Finlandja

Valproat Orion 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Il-Ġermanja

Valproat Sandoz 150 mg magensaftresistente Filmtabletten

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Il-Ġermanja

Valproat Sandoz 300 mg magensaftresistente Filmtabletten

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Il-Ġermanja

Valproat Sandoz 600 mg magensaftresistente Filmtabletten

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Il-Ġermanja |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Il-Ġermanja

Valproat STADA 300 mg retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| D-61118 Bad Vilbel |
| Il-Ġermanja |

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Il-Ġermanja

Valproat STADA 500 mg retard

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Il-Ġermanja |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Il-Ġermanja

Valproat Win 300 mg Retardtabletten

200 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Il-Ġermanja |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Il-Ġermanja

Valproat Win 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Il-Ġermanja |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Il-Ġermanja

Valproat-CT 150 mg Filmtabletten

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Il-Ġermanja |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Il-Ġermanja

Valproat-CT 300 mg Filmtabletten

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| CT Arzneimittel GmbH |
| --- |
| Lengeder Str. 42 a |
| D-13407 Berlin |
| Il-Ġermanja |

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Il-Ġermanja

Valproat-CT 600 mg Filmtabletten

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Il-Ġermanja |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Il-Ġermanja

Valproat-neuraxpharm

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Il-Ġermanja |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Il-Ġermanja

Valproat-neuraxpharm 150

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Il-Ġermanja |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Il-Ġermanja

Valproat-neuraxpharm 300

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Il-Ġermanja |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Il-Ġermanja

Valproat-neuraxpharm 600

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Il-Ġermanja |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Il-Ġermanja

Valproat-neuraxpharm chrono 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| neuraxpharm Arzneimittel GmbH u. Co.KG |
| --- |
| Elisabeth-Selbert-Str. 23 |
| D-40764 Langenfeld |
| Il-Ġermanja |

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Il-Ġermanja

Valproat-neuraxpharm chrono 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Il-Ġermanja |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Il-Ġermanja

Valproat-RPh 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Il-Ġermanja |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Il-Ġermanja

Valproat-RPh 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Il-Ġermanja |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Il-Ġermanja

Valproat-RPh 600 mg

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Dr. Lach Pharma Consulting |
| --- |
| Bahnhofstr. 6 |
| D-79359 Riegel |
| Il-Ġermanja |

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Il-Ġermanja

Valproat-RPh Lösung

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Il-Ġermanja

Valproat-Sandoz 300 mg Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Il-Ġermanja

Valproat-Sandoz 500 mg Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| Mylan dura GmbH |
| --- |
| Postfach 10 06 35 |
| D-64206 Darmstadt |
| Il-Ġermanja |

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Il-Ġermanja

valprodura 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Mylan dura GmbH |
| --- |
| Postfach 10 06 35 |
| D-64206 Darmstadt |
| Il-Ġermanja |

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Il-Ġermanja

valprodura 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| Mylan dura GmbH |
| --- |
| Postfach 10 06 35 |
| D-64206 Darmstadt |
| Il-Ġermanja |

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Il-Ġermanja

valprodura 600 mg

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Il-Ġermanja |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Il-Ġermanja

Valproinsäure Valeant 300

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Il-Ġermanja |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Il-Ġermanja

Valproinsäure Valeant 300 Retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Il-Ġermanja |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Il-Ġermanja

Valproinsäure Valeant 500 Retard

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| MEDA Pharma GmbH & Co. KG |
| --- |
| Benzstrasse 1 |
| 61352 Bad Homburg |
| Il-Ġermanja |

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Il-Ġermanja

Valproinsäure Valeant 600

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

D-89070 Ulm

Il-Ġermanja

Valproinsäure-ratiopharm 150

150 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

D-89070 Ulm

Il-Ġermanja

Valproinsäure-ratiopharm 300 Filmtabletten

300 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

D-89070 Ulm

Il-Ġermanja

Valproinsäure-ratiopharm 600

600 mg

pillola gastro-reżistenti

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

D-89070 Ulm

Il-Ġermanja

Valproinsäure-ratiopharm chrono 300 Retardtabletten

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

D-89070 Ulm

Il-Ġermanja

Valproinsäure-ratiopharm chrono 500 Retardtabletten

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

ratiopharm GmbH

D-89070 Ulm

Il-Ġermanja

Valproinsäure-ratiopharm Lösung

300 mg

soluzzjoni orali

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valsil PR 300 mg

199,8 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| IIP-Institut für industrielle Pharmazie |
| --- |
| Benzstr. 2 a |
| D-63741 Aschaffenburg |
| Il-Ġermanja |

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Il-Ġermanja

Valsil PR 500 mg

333 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674, Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674, Athens

Il-Greċja

DEPAKINE CHRONO

500 MG/TAB

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO

300 MG/TAB

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO (SPHERE)

50 MG/SACHET

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO (SPHERE)

100 MG/SACHET

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO (SPHERE)

250 MG/SACHET

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO (SPHERE)

500 MG/SACHET

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO (SPHERE)

750 MG/SACHET

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Greċja

| SANOFI-AVENTIS AEBE |
| --- |
| 348 Syggrou Avenue, Building A’ |
| Kallithea 17674 |
| Athens |
| Il-Greċja |

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Il-Greċja

DEPAKINE CHRONO (SPHERE)

1 000 MG/SACHET

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Ungerija

| Orion Corporation |
| --- |
| Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo

Il-Finlandja

ABSENOR

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Ungerija

| Orion Corporation |
| --- |
| Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo

Il-Finlandja

ABSENOR

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Ungerija

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

150 mg

kapsula, iebsa

Użu orali

L-Ungerija

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

300 mg

kapsula, iebsa

Użu orali

L-Ungerija

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

300 mg

pillola miksija b’rita

Użu orali

L-Ungerija

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

500 mg

kapsula, iebsa

Użu orali

L-Ungerija

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

500 mg

pillola miksija b’rita

Użu orali

L-Ungerija

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

43,38 mg/1 ml

mistura

Użu orali

L-Ungerija

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| L-Ungerija |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

L-Ungerija

DEPAKINE CHRONO

300 mg

pillola miksija b’rita

Użu orali

L-Ungerija

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| L-Ungerija |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

L-Ungerija

DEPAKINE CHRONO

500 mg

pillola miksija b’rita

Użu orali

L-Ungerija

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| L-Ungerija |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

L-Ungerija

DEPAKINE CHRONOSPHERE

50 mg

(14,51 mg/33,33 mg)

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Ungerija

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| L-Ungerija |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

L-Ungerija

DEPAKINE CHRONOSPHERE

100 mg

(29,03 mg/66,66 mg)

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Ungerija

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| L-Ungerija |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

L-Ungerija

DEPAKINE CHRONOSPHERE

250 mg

(72,61 mg/166,76 mg)

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Ungerija

| Sanofi-aventis |
| --- |
| Tó u. 1-5 |
| HU-1045 Budapest |
| L-Ungerija |

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

L-Ungerija

DEPAKINE

7,50g/150 ml

mistura

Użu orali

L-Ungerija

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335, Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Il-Ġermanja

ORFIRIL

300 mg

pillola gastro-reżistenti

Użu orali

L-Ungerija

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335, Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Il-Ġermanja

ORFIRIL

300 mg

pillola miksija

Użu orali

L-Ungerija

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| D-22335, Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Il-Ġermanja

ORFIRIL

600 mg

pillola miksija

Użu orali

L-Islanda

| Sanofi-aventis Norge A/S |
| --- |
| Strandveien 15 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

In-Norveġja

Depakine

200 mg/ml

soluzzjoni orali

Użu orali

L-Islanda

| Sanofi-aventis Norge A/S |
| --- |
| Strandveien 15 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

In-Norveġja

Depakine

200 mg

pillola gastro-reżistenti

Użu orali

L-Islanda

| Sanofi-aventis Norge A/S |
| --- |
| Strandveien 15 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

In-Norveġja

Depakine

500 mg

pillola gastro-reżistenti

Użu orali

L-Islanda

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

60 mg/ml

soluzzjoni orali

Użu orali

L-Islanda

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

150 mg

pillola gastro-reżistenti

Użu orali

L-Islanda

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

300 mg

pillola gastro-reżistenti

Użu orali

L-Islanda

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

600 mg

pillola gastro-reżistenti

Użu orali

L-Islanda

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril Retard

300 mg

pillola

Użu orali

L-Italja

| Biofutura Pharma S.p.A. |
| --- |
| Via Pontina Km 30,400 00040 |
| Pomezia - Roma L-Italja |

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma L-Italja

ORFILEPT

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Italja

| Biofutura Pharma S.p.A. |
| --- |
| Via Pontina Km 30,400 00040 |
| Pomezia - Roma L-Italja |

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma L-Italja

ORFILEPT

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Italja

| Biofutura Pharma S.p.A. |
| --- |
| Via Pontina Km 30,400 00040 |
| Pomezia - Roma L-Italja |

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma L-Italja

ORFILEPT

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| L-Italja |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

L-Italja

NAVALAC

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| L-Italja |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

L-Italja

NAVALAC

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| L-Italja |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

L-Italja

TOVAPROX

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| L-Italja |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

L-Italja

TOVAPROX

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| L-Italja |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

L-Italja

ACIDO VALPROICO SANDOZ

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Boccioni, 1 |
| 21040 Origgio (VA) |
| L-Italja |

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

L-Italja

ACIDO VALPROICO SANDOZ

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

200 mg

pillola gastro-reżistenti

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

500 mg

pillola gastro-reżistenti

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

200 mg/ml

soluzzjoni orali

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN CHRONO

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN CHRONO

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

DEPAKIN

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Italja

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Franza

DEPAKIN

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Italja

| Sanofi-Aventis spa |
| --- |
| Viale Luigi/Bodio, 37B |
| 20158 Milano |

Sanofi-Aventis spa

Viale Luigi/Bodio, 37B

20158 Milano

DEPAMIDE

300 mg

pillola gastro-reżistenti

Użu orali

L-Italja

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| L-Italja |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

L-Italja

DEPAMAG

200 mg

pillola gastro-reżistenti

Użu orali

L-Italja

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| L-Italja |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

L-Italja

DEPAMAG

500 mg

pillola gastro-reżistenti

Użu orali

L-Italja

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| L-Italja |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

L-Italja

DEPAMAG

100 mg/ml

soluzzjoni orali

Użu orali

L-Italja

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Il-Ġermanja |

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Il-Ġermanja |

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Il-Ġermanja

ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| EG Laboratori EuroGenerici S.P.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| L-Italja |

EG Laboratori EuroGenerici S.P.A.

Via Pavia, 6

20136 Milano

L-Italja

ACIDO VALPROICO E SODIO VALPROATO EG

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| EG Laboratori EuroGenerici S.P.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| L-Italja |

EG Laboratori EuroGenerici S.P.A.

Via Pavia, 6

20136 Milano

L-Italja

ACIDO VALPROICO E SODIO VALPROATO EG

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| L-Italja |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

L-Italja

SODIO VALPROATO WINTHROP

500 mg

pillola gastro-reżistenti

Użu orali

L-Italja

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| L-Italja |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

L-Italja

SODIO VALPROATO WINTHROP

200 mg/ml

soluzzjoni orali

Użu orali

L-Italja

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| L-Italja |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

L-Italja

SODIO VALPROATO WINTHROP

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| L-Italja |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

L-Italja

SODIO VALPROATO WINTHROP

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Italja

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| L-Italja |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

L-Italja

SODIO VALPROATO WINTHROP

200 mg

pillola gastro-reżistenti

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epi-Chrono

PA 540/149/1

200 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epi-Chrono

PA 540/149/2

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epi-Chrono

PA 540/149/3

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Crushable

PA 540/150/1

100 mg

pillola

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Enteric

PA 540/150/2

200 mg

pillola miksija gastro-reżistenti

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Enteric

PA 540/150/3

500 mg

pillola miksija gastro-reżistenti

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chronosphere

PA 540/150/4

50 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chronosphere

PA 540/150/5

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chronosphere

PA 540/150/6

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chronosphere

PA 540/150/7

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chronosphere

PA 540/150/8

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chronosphere

PA 540/150/9

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chrono

PA 540/150/10

200 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chrono

PA 540/150/11

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Chrono

PA 540/150/12

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Intravenous

PA 540/150/13

400 mg

trab u solvent għall-infużjoni/injezzjoni

Ġol-vini

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Liquid

PA 540/150/14

200 mg/5 ml

soluzzjoni orali

Użu orali

L-Irlanda

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| L-Irlanda |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

L-Irlanda

Epilim Syrup

PA 540/150/15

200 mg/5 ml

mistura

Użu orali

Il-Latvja

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Is-Slovenja

Valproate sodium Sandoz 300 mg prolonged-release tablets

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Is-Slovenja

Valproate sodium Sandoz 500 mg prolonged-release tablets

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Stada Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |
| Il-Ġermanja |

Stada Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Il-Ġermanja

Convulex 150 mg gastro-resistant capsules, soft

150 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex 300 mg gastro-resistant capsules, soft

300 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex 500 mg gastro-resistant capsules, soft

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex 500 mg gastro-resistant capsules, soft

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex retard 300 mg prolonged release tablets

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex retard 500 mg prolonged release tablets

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex 50 mg/ml syrup

50 mg/ml

mistura

Użu orali

Il-Latvja

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| L-AWSTRIJA |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

L-AWSTRIJA

Convulex 300 mg/ml oral solution

300 mg/ml

soluzzjoni orali

Użu orali

Il-Latvja

| Sanofi-aventis Latvia SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Il-Latvja |

Sanofi-aventis Latvia SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Il-Latvja

Depakine Chrono 300 mg prolonged release tablets

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Sanofi-aventis Latvia SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Il-Latvja |

Sanofi-aventis Latvia SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Il-Latvja

Depakine Chrono 500 mg prolonged release tablets

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Sanofi-aventis Latvia SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Il-Latvja |

Sanofi-aventis Latvia SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Il-Latvja

Depakine 57,64 mg/ml syrup

57,64 mg/ml

mistura

Użu orali

Il-Latvja

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI - 02200 Espoo |
| IL-FINLANDJA |

Orion Corporation

Orionintie 1

FI - 02200 Espoo

IL-FINLANDJA

Absenor 500 mg prolonged release tablets

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Latvja

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI - 02200 Espoo |
| IL-FINLANDJA |

Orion Corporation

Orionintie 1

FI - 02200 Espoo

IL-FINLANDJA

Absenor 300 mg prolonged release tablets

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex retard

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex

50 mg/ml

mistura

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex

300 mg/ml

soluzzjoni orali

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex

150 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex

300 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Litwanja

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| L-Awstrija |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

L-Awstrija

Convulex

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

Il-Litwanja

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Absenor

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Il-Finlandja

Absenor

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine

57,64 mg/ml

mistura

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chrono

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| UAB “Sanofi Aventis” Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Il-Litwanja |

UAB “Sanofi Aventis” Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Il-Litwanja

Depakine Chronosphere

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Il-Litwanja

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Il-Ġermanja |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Prodepa

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Is-Slovenja

Valproate sodium Sandoz

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Litwanja

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Is-Slovenja

Valproate sodium Sandoz

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE

30 %

soluzzjoni

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE

6 %

mistura

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE CHRONO

300 mg

pillola

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE CHRONO

500 mg

pillola

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE ENTERIC

150 mg

pillola

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE ENTERIC

300 mg

pillola

Użu orali

Il-Lussemburgu

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Il-Belġju |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Il-Belġju

DEPAKINE ENTERIC

500 mg

pillola

Użu orali

Il-Lussemburgu

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

250 mg/5 ml

mistura

Użu orali

Il-Lussemburgu

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

300 mg

kapsula

Użu orali

Il-Lussemburgu

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| L-Awstrija |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX

500 mg

kapsula

Użu orali

Il-Lussemburgu

| Ratiopharm GmbH Arzneimittel Postfach 3380 |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

Ratiopharm GmbH Arzneimittel Postfach 3380

D-89070 Ulm

Il-Ġermanja

Valproinsäure-Ratiopharm

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Ratiopharm GmbH Arzneimittel Postfach 3380 |
| --- |
| D-89070 Ulm |
| Il-Ġermanja |

Ratiopharm GmbH Arzneimittel Postfach 3380

D-89070 Ulm

Il-Ġermanja

Valproinsäure-Ratiopharm

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Hexal AG |
| --- |
| Industriestrasse 25 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Il-Ġermanja

Valproat-Hexal Chrono

300 mg

pillola

Użu orali

Il-Lussemburgu

| Hexal AG |
| --- |
| Industriestrasse 25 |
| D-83607 Holzkirchen |
| Il-Ġermanja |

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Il-Ġermanja

Valproat-Hexal Chrono

500 mg

pillola

Użu orali

Il-Lussemburgu

| Eurogenerics s.a. |
| --- |
| Esplanade Heysel B.22 |
| B-1020 Bruxelles |
| Il-Belġju |

Eurogenerics s.a.

Esplanade Heysel B.22

B-1020 Bruxelles

Il-Belġju

Valproate Retard-EG

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| Eurogenerics s.a. |
| --- |
| Esplanade Heysel |
| B.22 B-1020 Bruxelles |
| Il-Belġju |

Eurogenerics s.a.

Esplanade Heysel

B.22 B-1020 Bruxelles

Il-Belġju

Valproate Retard-EG

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| Norton Healthcare Limited |
| --- |
| Ivax Pharmaceuticals |
| Ivax Quays |
| Albert Basin, Royal Docks |
| London E16 2QJ |
| Ir-Renju Unit |

Norton Healthcare Limited

Ivax Pharmaceuticals

Ivax Quays

Albert Basin, Royal Docks

London E16 2QJ

Ir-Renju Unit

Sodium valproate oral solution BP

200 mg/5 ml

soluzzjoni orali

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim liquid

200 mg/5 ml

likwidu orali

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chrono 200 Controlled Release

200 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chrono 300

Controlled release

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chrono 500

Controlled release

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 50 mg

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 100 mg

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Epilim Chronosphere MR 250 mg

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 500 mg

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 750 mg

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Malta

| Sanofi-Aventis Malta Limited |
| --- |
| Triq Kanonku K. Pirotta |
| Birkirkara BKR 1114 |
| Malta |

Sanofi-Aventis Malta Limited

Triq Kanonku K. Pirotta

Birkirkara BKR 1114

Malta

Epilim Chronosphere MR 1 000 mg

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril Long

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril Long

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril Long

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril Long

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril Retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

150 mg

pillola gastro-reżistenti

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

300 mg

pillola gastro-reżistenti

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

600 mg

pillola gastro-reżistenti

Użu orali

In-Norveġja

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

In-Norveġja

Deprakine

100 mg

pillola gastro-reżistenti

Użu orali

In-Norveġja

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

In-Norveġja

Deprakine

300 mg

pillola gastro-reżistenti

Użu orali

In-Norveġja

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

In-Norveġja

Deprakine

500 mg

pillola gastro-reżistenti

Użu orali

In-Norveġja

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril

60 mg/mL

soluzzjoni orali

Użu orali

In-Norveġja

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| In-Norveġja |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

In-Norveġja

Deprakine

60 mg/mL

soluzzjoni orali

Użu orali

Il-Polonja

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

L-Awstrija

Convulex 150

150 mg

kapsula, ratba

Użu orali

Il-Polonja

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

L-Awstrija

Convulex 300

300 mg

kapsula, ratba

Użu orali

Il-Polonja

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

L-Awstrija

Convulex

500 mg

kapsula, ratba

Użu orali

Il-Polonja

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

L-Awstrija

Convulex

50 mg/ml

mistura

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril

300 mg/5 ml (60 mg/ml)

soluzzjoni orali

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril 150

150 mg

pillola gastro-reżistenti

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril 300

300 mg

pillola gastro-reżistenti

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril 600

600 mg

pillola gastro-reżistenti

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril 300 retard

300 mg

pillola gastro-reżistenti li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril Long 150

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril Long 300

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril Long 500

500 mg

pillola ċkejkna li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Il-Ġermanja |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Il-Ġermanja

Orfiril Long 1 000

1 000 mg

pillola ċkejkna li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Il-Ġermanja

Valproic Acid ER-APC 300

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm89079 |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm89079

Il-Ġermanja

Valproic Acid ER-APC 500

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Il-Ġermanja

Valpro-ratiopharm Chrono 300 mg

199,8 mg + 87 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Il-Ġermanja |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Il-Ġermanja

Valpro-ratiopharm Chrono 500 mg

333 mg + 145 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| Warsaw 00-203 |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

Warsaw 00-203

Il-Polonja

Depakine Chrono 300

200 mg + 87 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Il-Polonja

Depakine Chrono 500

333 mg + 145 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Il-Polonja

Depakine Chronosphere 100

66,66 mg + 29,03 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Il-Polonja

Depakine Chronosphere 250

166,76 mg + 72,61 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Il-Polonja

Depakine Chronosphere 500

333,30 mg + 145,14 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Il-Polonja

Depakine Chronosphere 750

500,06 mg + 217,75 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Il-Polonja |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Il-Polonja

Depakine Chronosphere 1 000

666,60 mg + 290,27 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Polonja

| Sanofi-Aventis France |
| --- |
| 1-13 bld Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France

1-13 bld Romain Rolland

75014 Paris

Franza

Depakine

288,2 mg/5 ml

mistura

Użu orali

Il-Polonja

| Sanofi-Aventis France |
| --- |
| 1-13 bld Romain Rolland |
| 75014 Paris |
| Franza |

Sanofi-Aventis France

1-13 bld Romain Rolland

75014 Paris

Franza

Depakine 200

200 mg

pillola miksija b’rita

Użu orali

Il-Polonja

| ICN Polfa Rzeszów S.A. |
| --- |
| Przemysłowa 2 st. |
| Rzeszów 35-959 |
| Il-Polonja |

ICN Polfa Rzeszów S.A.

Przemysłowa 2 st.

Rzeszów 35-959

Il-Polonja

Dipromal

200 mg

pillola miksija b’rita

Użu orali

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| Kundl 6250 |
| L-Awstrija |

Sandoz GmbH

Biochemiestrasse 10

Kundl 6250

L-Awstrija

ValproLEK 300

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| Kundl 6250 |
| L-Awstrija |

Sandoz GmbH

Biochemiestrasse 10

Kundl 6250

L-Awstrija

ValproLEK 500

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| Orion Corporation |
| --- |
| Orionintie 1 |
| Espoo 02200 |
| Il-Finlandja |

Orion Corporation

Orionintie 1

Espoo 02200

Il-Finlandja

Absenor

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Il-Polonja

| Orion Corporation |
| --- |
| Orionintie 1 |
| Espoo 02200 |
| Il-Finlandja |

Orion Corporation

Orionintie 1

Espoo 02200

Il-Finlandja

Absenor

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine

200 mg/ml

soluzzjoni orali

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chrono 300

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chrono 500

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil

200 mg

pillola miksija

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil

500 mg

pillola gastro-reżistenti

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil

200 mg/ml

soluzzjoni orali

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil-R

250 mg

pillola miksija

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil-R

500 mg

pillola miksija

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine

40 mg/ml

mistura

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil 150

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil 300

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil 500

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Portugall

| Tecnifar - Indústria Técnica Farmacêutica, S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Il-Portugall |

Tecnifar - Indústria Técnica Farmacêutica, S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Il-Portugall

Diplexil 1 000

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 50/350

50 - 350 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 500/1 000

500 - 1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 50 mg

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 100 mg

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 250 mg

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 500 mg

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 750 mg

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos Farmacêuticos, S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Il-Portugall |

Sanofi-Aventis - Produtos Farmacêuticos, S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Il-Portugall

Depakine Chronosphere 1 000 mg

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Il-Portugall

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Il-Portugall |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Il-Portugall

Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, Edifício 4, Quinta da Beloura |
| 2710-444 Sintra |
| Il-Portugall |

Generis Farmacêutica, S.A.

Office Park da Beloura, Edifício 4, Quinta da Beloura

2710-444 Sintra

Il-Portugall

Ácido Valpróico Generis

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, Edifício 4, Quinta da Beloura |
| 2710-444 Sintra |
| Il-Portugall |

Generis Farmacêutica, S.A.

Office Park da Beloura, Edifício 4, Quinta da Beloura

2710-444 Sintra

Il-Portugall

Ácido Valpróico Generis

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Il-Portugall |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Il-Portugall

Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Il-Portugall |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Il-Portugall

Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Il-Portugall |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Il-Portugall

Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONOSPHERE 100 mg

29,03 mg/66,66 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONOSPHERE 250 mg

72,61 mg/166,76 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONOSPHERE 500 mg

145,14 mg/333,3 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONOSPHERE 750 mg

217,75 mg/500,06 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONOSPHERE 1 000 mg

290,27 mg/666,60 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE

57,64 mg/ml

mistura

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONO 300 mg

87 mg/199,8 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE CHRONO 500 mg

145 mg/333 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| SANOFI AVENTIS FRANCE |
| --- |
| 1-13 boulevard Romain Rolland |
| 75014 Paris |
| Franza |

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Franza

DEPAKINE 200 mg

200 mg

pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL 150

150 mg

pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL 300

300 mg

pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL 600

600 mg

pillola gastro-reżistenti

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 150 mg

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 300 mg

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 500 mg

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL LONG 1 000 mg

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Rumanija

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Il-Ġermanja

ORFIRIL SIROP

300 mg/5 ml

mistura

Użu orali

Ir-Rumanija

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 150 mg

150 mg

kapsula gastro-reżistenti, ratba

Użu orali

Ir-Rumanija

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 300 mg

300 mg

kapsula gastro-reżistenti, ratba

Użu orali

Ir-Rumanija

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 500 mg

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

Ir-Rumanija

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX RETARD 300 mg

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX RETARD 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Rumanija

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| L-Awstrija |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

L-Awstrija

CONVULEX 50 mg/ml

50 mg/ml

mistura

Użu orali

Ir-Rumanija

| REMEDICA Ltd. |
| --- |
| Limassol Industrial Estate |
| Aharnon P.O Box 51706 |
| 3508 Limassol |
| Ċipru |

REMEDICA Ltd.

Limassol Industrial Estate

Aharnon P.O Box 51706

3508 Limassol

Ċipru

PETILIN 200

200 mg

pillola miksija b’rita

Użu orali

Ir-Rumanija

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu nr. 31 |
| Sector 2, București |
| Ir-Rumanija |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu nr. 31

Sector 2, București

Ir-Rumanija

VALEPIL

200 mg/5 ml

mistura

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Propymal Enteric 150 mg

150 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Propymal Enteric 300 mg

300 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Propymal Enteric 450 mg

450 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Propymal Enteric 600 mg

600 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Zuur

125 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Zuur

250 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Zuur

500 mg

kapsula gastro-reżistenti, ratba

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine

300 mg

pillola

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine

300 mg/ml

qtar orali, soluzzjoni

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Retard

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Enteric

150 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Enteric

300 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Enteric

500 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine vloeistof voor kinderen

300 mg/ml

soluzzjoni orali

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine suikervrije stroop

40 mg/ml

mistura

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Natriumvalproaat Enteric Winthrop 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Natriumvalproaat Enteric Winthrop 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Natriumvalproaat Enteric Winthrop 500 mg

500 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Natrii Valproas

300 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Natriumvalproaat Apotex 150 mg

150 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Natriumvalproaat Apotex 300 mg

300 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Natriumvalproaat Apotex 600 mg

600 mg

pillola gastro-reżistenti

Użu orali

L-Olanda

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| L-Olanda |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

L-Olanda

Natriumvalproaat Apotex 300 mg/5 ml

60 mg/ml

soluzzjoni orali

Użu orali

L-Olanda

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| L-Olanda |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

L-Olanda

Orfiril CR 150 mg

150 mg

kapsula li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| L-Olanda |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

L-Olanda

Orfiril CR 300 mg

300 mg

kapsula li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| L-Olanda |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

L-Olanda

Orfiril CR 500 mg

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| L-Olanda |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

L-Olanda

Orfiril CR 1 000 mg

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam |
| L-Olanda |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam

L-Olanda

Natriumvalproaat ratiopharm chrono 300 mg

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam |
| L-Olanda |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam

L-Olanda

Natriumvalproaat ratiopharm chrono 500 mg

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chrono 300

200 mg sodium valproate and 87 mg valproic acid

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chrono 500

333 mg sodium valproate and 145 mg valproic acid

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Natriumvalproaat Chrono Winthrop 300 mg

200 mg sodium valproate and 87 mg valproic acid

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Natriumvalproaat Chrono Winthrop 500 mg

333 mg sodium valproate and 145 mg valproic acid

pillola li terħi l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere

220 mg sodium valproate and 95,8 mg valproic acid per gram

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere 50 mg

33,33 sodium valproate and 14,51 mg valproic acid per sachet

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere 100 mg

66,66 sodium valproate and 29,03 mg valproic acid per sachet

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere 250 mg

166,76 sodium valproate and 72,61 mg valproic acid per sachet

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere 500 mg

333,30 sodium valproate and 145,14 mg valproic acid per sachet

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere 750 mg

500,06 sodium valproate and 217,75 mg valproic acid per sachet

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| L-Olanda |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

L-Olanda

Depakine Chronosphere 1 000 mg

666,60 sodium valproate and 290,27 mg valproic acid per sachet

grani li jerħu l-mediċina b’mod modifikat

Użu orali

L-Olanda

| Ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| L-Olanda |

Ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

L-Olanda

Natriumvalproaat ratiopharm chrono 300 mg

200 mg sodium valproate and 87 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| L-Olanda |

Ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

L-Olanda

Natriumvalproaat ratiopharm chrono 500 mg

333 mg sodium valproate and 145 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| 4879 AC Etten-Leur |
| L-Olanda |

Centrafarm Services BV

Nieuwe Donk 9

4879 AC Etten-Leur

L-Olanda

Natriumvalproaat Chrono CF 300 mg

200 mg sodium valproate and 87 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| 4879 AC Etten-Leur |
| L-Olanda |

Centrafarm Services BV

Nieuwe Donk 9

4879 AC Etten-Leur

L-Olanda

Natriumvalproaat Chrono CF 500 mg

333 mg sodium valproate and 145 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| L-Olanda |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

L-Olanda

Natriumvalproaat Chrono Sandoz 300 mg

200 mg sodium valproate and 87 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| L-Olanda |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

L-Olanda

Natriumvalproaat Chrono Sandoz 500 mg

333 mg sodium valproate and 145 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| L-Olanda |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

L-Olanda

Natriumvalproaat Sandoz Chrono 300

200 mg sodium valproate and 87 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| L-Olanda |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

L-Olanda

Natriumvalproaat Sandoz Chrono 500

333 mg sodium valproate and 145 mg valproic acid

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintrie 1 |
| 02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orion Pharma

Orionintrie 1

02200 Espoo

Il-Finlandja

Absenor 300 mg tablety s predĺženým uvoľňovaním

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintrie 1 |
| 02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orion Pharma

Orionintrie 1

02200 Espoo

Il-Finlandja

Absenor 500 mg tablety s predĺženým uvoľňovaním

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

L-Awstrija

Convulex 150 mg kapsuly

150 mg

kapsula

Użu orali

Is-Slovakja

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

L-Awstrija

Convulex 300 mg kapsuly

300 mg

kapsula

Użu orali

Is-Slovakja

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

L-Awstrija

Convulex 500 mg kapsuly

500 mg

kapsula

Użu orali

Is-Slovakja

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

L-Awstrija

CONVULEX

50 mg/ml

mistura

Użu orali

Is-Slovakja

| G.L. Pharma GmbH Schlossplatz 1 |
| --- |
| 8502 Lannach |
| L-Awstrija |

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

L-Awstrija

Convulex 300 mg/ml kvapky

300 mg/ml

qtar orali

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

DEPAKINE

100 mg/ml

mistura

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

DEPAKINE CHRONO 500 mg

500 mg

pillola miksija b’rita li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

Depakine Chronosphere 50 mg

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

Depakine Chronosphere 100 mg

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

Depakine Chronosphere 250 mg

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

Depakine Chronosphere 500 mg

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

Depakine Chronosphere 750 mg

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Is-Slovakja

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Is-Slovakja |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Is-Slovakja

Depakine Chronosphere 1 000 mg

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril 150

150 mg

pillola gastro-reżistenti

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril 300

300 mg

pillola gastro-reżistenti

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril 600

600 mg

pillola gastro-reżistenti

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril long 150 mg

150 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril long 300 mg

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril long 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Il-Ġermanja

Orfiril long 1 000 mg

1 000 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Il-Ġermanja |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Il-Ġermanja

Valpro-ratiopharm Chrono 500 mg

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Is-Slovenja

Valproát chrono Sandoz 300 mg tablety s predĺženým uvoľňovaním

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovakja

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Is-Slovenja |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Is-Slovenja

Valproát chrono Sandoz 500 mg tablety s predľženým uvoľňovaním

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovenja

| Sanofi-Aventis d.o.o. |
| --- |
| Dunajska c. 119 |
| 1000 Ljubljana |
| Is-Slovenja |

Sanofi-Aventis d.o.o.

Dunajska c. 119

1000 Ljubljana

Is-Slovenja

Depakine chrono 500 mg filmsko obložene tablet s podaljšanim sproščanjem

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Is-Slovenja

| Sanofi-Aventis d.o.o. |
| --- |
| Dunajska c. 119 |
| 1000 Ljubljana |
| Is-Slovenja |

Sanofi-Aventis d.o.o.

Dunajska c. 119

1000 Ljubljana

Is-Slovenja

Depakine chrono 300 mg filmsko obložene tablet s podaljšanim sproščanjem

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE 200 mg comprimidos gastrorresistentes

200 mg

pillola gastro-reżistenti

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE solución oral

200 mg/ml

soluzzjoni orali

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CRONO 500 mg comprimidos recubiertos

500 mg

pillola miksija

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CRONO 300 mg comprimidos recubiertos

300 mg

pillola miksija

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE 500 mg comprimidos gastrorresistentes

500 mg

pillola gastro-reżistenti

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CHRONOSPHERE 250 mg granulado de liberación modificada

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Spanja

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

DEPAKINE CHRONOSPHERE 1 000 MG Granulado de liberación modificada

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Spanja

| WINTHROP PHARMA ESPAÑA, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

WINTHROP PHARMA ESPAÑA, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

VALPROATO SODICO CRONO WINTHROP 300 mg comprimidos de liberación prolongada

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| WINTHROP PHARMA ESPAÑA, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanja |

WINTHROP PHARMA ESPAÑA, S.A.

Josep Plá, 2

08019 Barcelona

Spanja

VALPROATO SODICO CRONO WINTHROP 500 mg comprimidos de liberación prolongada

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Il-Ġermanja

MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

Spanja

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Il-Ġermanja

MILZONE 1 000 MG GRÁNULOS DE LIBERACIÓN PROLONGADA

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Spanja

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Il-Ġermanja

MILZONE 500 MG GRÁNULOS DE LIBERACIÓN PROLONGADA

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Spanja

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Il-Ġermanja |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Il-Ġermanja

MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA

300 mg

kapsula li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor

200 mg/ml

qtar orali, soluzzjoni

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor

300 mg

pillola

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor

100 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor

300 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor

500 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor

60 mg/ml

soluzzjoni orali

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor Depot

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Il-Finlandja |

Orion Corporation

Orionintie

FI-02200 Espoo

Il-Finlandja

Absenor Depot

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl

200 mg/ml

qtar orali, soluzzjoni

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl

100 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl

300 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl

500 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl

60 mg/ml

soluzzjoni orali

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

100 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

250 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

750 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Isvezja

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| L-Isvezja |

Sanofi-aventis AB

Box 14142

167 14 Bromma

L-Isvezja

Ergenyl Retard

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Isvezja

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Il-Ġermanja

Orfiril

150 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Il-Ġermanja

Orfiril

300 mg

pillola gastro-reżistenti

Użu orali

L-Isvezja

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Il-Ġermanja

Orfiri long

150 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Isvezja

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Il-Ġermanja

Orfiril long

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

L-Isvezja

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Il-Ġermanja

Orfiril long

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

L-Isvezja

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Il-Ġermanja |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Il-Ġermanja

Orfiril long

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon |
| EX32 8NS |
| Ir-Renju Unit |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon

EX32 8NS

Ir-Renju Unit

SODIUM VALPROATE TABLETS BP 200 MG (E/C)

200 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| TEVA UK LIMITED |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex |
| BN22 9AG |
| Ir-Renju Unit |

TEVA UK LIMITED

Brampton Road

Hampden Park

Eastbourne

East Sussex

BN22 9AG

Ir-Renju Unit

SODIUM VALPROATE ENTERIC COATED TABLETS 200 MG

200 mg

pillola miksija

Użu orali

Ir-Renju Unit

| TEVA UK LIMITED |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex |
| BN22 9AG |
| Ir-Renju Unit |

TEVA UK LIMITED

Brampton Road

Hampden Park

Eastbourne

East Sussex

BN22 9AG

Ir-Renju Unit

SODIUM VALPROATE ENTERIC COATED TABLETS 500 MG

500 mg

pillola miksija

Użu orali

Ir-Renju Unit

| NORTON HEALTHCARE LIMITED |
| --- |
| Albert Basin, Royal Dock |
| Canning Town |
| London E16 2QJ |
| Ir-Renju Unit |

NORTON HEALTHCARE LIMITED

Albert Basin, Royal Dock

Canning Town

London E16 2QJ

Ir-Renju Unit

SODIUM VALPROATE ORAL SOLUTION BP 200 MG/5 ML

200 mg/5 ml

soluzzjoni orali

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

DEPAKOTE 250 MG TABLETS

250 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

DEPAKOTE 500 MG TABLETS

500 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

EPILIM CHRONOSPHERE MR 50 MG MODIFIED RELEASE GRANULES

50 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

EPILIM CHRONOSPHERE MR 100 MG MODIFIED RELEASE GRANULES

100 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

EPILIM CHRONOSPHERE MR 250 MG MODIFIED RELEASE GRANULES

250 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

EPILIM CHRONOSPHERE MR 500 MG MODIFIED RELEASE GRANULES

500 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

EPILIM CHRONOSPHERE MR 750 MG MODIFIED RELEASE GRANULES

750 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| Ir-Renju Unit |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

Ir-Renju Unit

EPILIM CHRONOSPHERE MR 1 000 MG MODIFIED RELEASE GRANULES

1 000 mg

grani li jerħu l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| GENERICS (UK) LIMITED |
| --- |
| Station Close |
| Potters Bar |
| Herts, EN6 1TL |
| Ir-Renju Unit |

GENERICS (UK) LIMITED

Station Close

Potters Bar

Herts, EN6 1TL

Ir-Renju Unit

SODIUM VALPROATE TABLETS BP 200 MG

200 mg

pillola miksija

Użu orali

Ir-Renju Unit

| GENERICS (UK) LIMITED |
| --- |
| Station Close |
| Potters Bar |
| Herts, EN6 1TL |
| Ir-Renju Unit |

GENERICS (UK) LIMITED

Station Close

Potters Bar

Herts, EN6 1TL

Ir-Renju Unit

SODIUM VALPROATE TABLETS BP 500 MG EC

500 mg

pillola miksija

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

L-Awstrija

CONVULEX CAPSULES 300 MG

300 mg

kapsula gastro-reżistenti

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

L-Awstrija

CONVULEX CAPSULES 500 MG

500 mg

kapsula gastro-reżistenti

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

L-Awstrija

CONVULEX CAPSULES 150 MG

150 mg

kapsula gastro-reżistenti

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

L-Awstrija

CONVULEX CR 300 MG PROLONGED RELEASE TABLETS

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3, |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3,

A-1160, Vienna

L-Awstrija

CONVULEX CR 500 MG PROLONGED RELEASE TABLETS

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

L-Awstrija

EPIVAL CR 500 MG PROLONGED RELEASE TABLETS

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| L-Awstrija |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

L-Awstrija

EPIVAL CR 300 MG PROLONGED RELEASE TABLETS

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM 100 MG CRUSHABLE TABLET

100 mg

pillola

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM 200 EC TABLETS

200 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM 500 ENTERIC COATED TABLETS

500 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM CHRONO 300 CONTROLLED RELEASE

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM LIQUID OR SODIUM VALPROATE 200 MG/5 ML LIQUID

200 mg/5 ml

soluzzjoni orali

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM SYRUP 200 MG/5 ML

200 mg/5 ml

soluzzjoni orali

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM CHRONO 200 CONTROLLED RELEASE TABLETS 200 MG

200 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| Ir-Renju Unit |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

Ir-Renju Unit

EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS 500 MG

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street |
| Guildford Surrey, |
| GU1 4YS |
| Ir-Renju Unit |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street

Guildford Surrey,

GU1 4YS

Ir-Renju Unit

SODIUM VALPROATE 200 MG ENTERIC COATED TABLETS

200 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, |
| Guildford Surrey, |
| GU1 4YS |
| Ir-Renju Unit |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street,

Guildford Surrey,

GU1 4YS

Ir-Renju Unit

SODIUM VALPROATE 500 MG ENTERIC COATED TABLETS

500 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| RATIOPHARM GMBH |
| --- |
| Graff-Arco Strasse 3, Ulm, D-89079 |
| Il-Ġermanja |

RATIOPHARM GMBH

Graff-Arco Strasse 3, Ulm, D-89079

Il-Ġermanja

VALPROTEK CR 300 MG (PROLONGED RELEASE) TABLETS

300 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| RATIOPHARM GMBH |
| --- |
| Graff-Arco Strasse 3, Ulm, D-89079 |
| Il-Ġermanja |

RATIOPHARM GMBH

Graff-Arco Strasse 3, Ulm, D-89079

Il-Ġermanja

VALPROTEK CR 500 MG (PROLONGED RELEASE) TABLETS

500 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| Ir-Renju Unit |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

Ir-Renju Unit

SODIUM VALPROATE LIQUID 200 MG/5 ML

200 mg

soluzzjoni orali

Użu orali

Ir-Renju Unit

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| Ir-Renju Unit |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

Ir-Renju Unit

MAPHILEP 200 MG MR TABLETS

200 mg

pillola li terħi l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| Ir-Renju Unit |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

Ir-Renju Unit

MAPHILEP 300 MG MR TABLETS

300 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| Ir-Renju Unit |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

Ir-Renju Unit

MAPHILEP 500 MG MR TABLETS

500 mg

pillola li terħi l-mediċina b’mod modifikat

Użu orali

Ir-Renju Unit

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| Ir-Renju Unit |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

Ir-Renju Unit

EPISENTA 150 MG PROLONGED-RELEASE CAPSULE

150 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Renju Unit

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| Ir-Renju Unit |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

Ir-Renju Unit

EPISENTA 300 MG PROLONGED-RELEASE CAPSULE

300 mg

kapsula li terħi l-mediċina bil-mod, iebsa

Użu orali

Ir-Renju Unit

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| Ir-Renju Unit |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

Ir-Renju Unit

EPISENTA 500 MG PROLONGED-RELEASE GRANULES

500 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| Ir-Renju Unit |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

Ir-Renju Unit

EPISENTA 1 000 MG PROLONGED-RELEASE GRANULES

1 000 mg

grani li jerħu l-mediċina bil-mod

Użu orali

Ir-Renju Unit

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| Ir-Renju Unit |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

Ir-Renju Unit

ORLEPT (SF) LIQUID OR SODIUM VALPROATE 40 MG/ML ORAL SOLUTION

40 mg/ml

soluzzjoni orali

Użu orali

Ir-Renju Unit

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| Ir-Renju Unit |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

Ir-Renju Unit

ORLEPT 200 MG GASTRO-RESISTANT TABLETS

200 mg

pillola gastro-reżistenti

Użu orali

Ir-Renju Unit

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| Ir-Renju Unit |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

Ir-Renju Unit

ORLEPT 500 MG GASTRO-RESISTANT TABLETS

500 mg

pillola gastro-reżistenti

Użu orali

---

ANNESS V

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW U D-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | GUERBET |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

Stat Membru EU/EEA

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem - Injektionslösung

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

Gadopentetsäure Insight 500 Mikromol/ml Injektionslösung

469 mg/ml Gadopentetat-Dimeglumin (78,63 mg/ml Gadolinium)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bayer Austria GmbH |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH

Herbststrasse 6-10

1160 Wien

Austria

Gadovist 1,0 mmol/ml Injektionslösung in Fertigspritzen/Patronen

604,72 mg/ml Gadobutrol (157,25 mg/ml Gadolinium)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Gadovist 1,0 mmol/ml - Injektionslösung

604,72 mg/ml Gadobutrol (157,25 mg/ml Gadolinium)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

Magnegita 500 Mikromol/ml Injektionslösung

469 mg/ml Gadopentetat-Dimeglumin (78,63 mg/ml Gadolinium)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Magnevist 0,5 mmol/ml - Injektionslösung

469 mg/ml Gadopentetsäure Dimeglumin

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

L-Awstrija

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

MultiHance 0,5 M - Injektionslösung

334 mg/ml Gadobensäure Dimeglumin

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

MultiHance 0,5 mmol/ml Injektionslösung in einer Fertigspritze

334 mg/ml Gadobensäure Dimeglumin

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| GE Healthcare Handels GmbH |
| --- |
| Europlaza Gebäude E |
| Technologiestr. 10 |
| 1120 Wien |
| Austria |

GE Healthcare Handels GmbH

Europlaza Gebäude E

Technologiestr. 10

1120 Wien

Austria

Omniscan 0,5 mmol/ml - parenterale Kontrastmittellösung

287 mg/ml Gadodiamid

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Primovist 0,25 mmol/m Injektionslösung in einer Fertigspritze

181,43 mg/ml Gadoxetsäure-Dinatrium

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bayer Austria GmbH, |
| --- |
| Herbststrasse 6-10 |
| 1160 Wien |
| Austria |

Bayer Austria GmbH,

Herbststrasse 6-10

1160 Wien

Austria

Primovist 0,25 mmol/ml Injektionslösung in einer Durchstechflasche

181,43 mg/ml Gadoxetsäure-Dinatrium

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Awstrija

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

Prohance - Injektionslösung

279,3 mg/ml Gadoteridol (78,61 mg/ml Gadolinium)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| Codali S.A. |
| --- |
| Avenue Henri Dunant 31 |
| 1140 Bruxelles |
| Belgium |

Codali S.A.

Avenue Henri Dunant 31

1140 Bruxelles

Belgium

DOTAREM

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

GADOPENTETATE CURAGITA 500MICROMOL/ML

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

GADOVIST

1,0 mmol-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| Insight Agents GmbH |
| --- |
| Ringstraat 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstraat 19 B

69115 Heidelberg

Germany

MAGNEGITA

500 micromol-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

MAGNEVIST

0,5 mmol-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MULTIHANCE

0,5 M

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| GE HEALTHCARE BVBA |
| --- |
| Kouterveldstraat 20 |
| 1831 DIEGEM |
| Belgium |

GE HEALTHCARE BVBA

Kouterveldstraat 20

1831 DIEGEM

Belgium

OMNISCAN

0,5 mmol-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

PRIMOVIST

0,25 mmol-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Belġju

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

PROHANCE

279,3 mg-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| Bayer Schering Pharma AG |
| --- |
| Muellerstrasse 178 |
| 13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Muellerstrasse 178

13353 Berlin

Germany

Gadovist

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist

181,43 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O.Box 4220 Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O.Box 4220 Nydalen

N-0401 Oslo

Norway

Omniscan

287 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Bulgarija

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| D–69115, Heidellberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

D–69115, Heidellberg

Germany

Magnegita

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ċipru

| PHADISCO LTD |
| --- |
| 185 YIANNOU GRANIDIOTI AVE, |
| 2235 LATSIA |
| CYPRUS |

PHADISCO LTD

185 YIANNOU GRANIDIOTI AVE,

2235 LATSIA

CYPRUS

OMNISCAN

0,5 MMOL/ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ċipru

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20 |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST PFS

0,25 MMOL/ML

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Ċipru

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20 |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST

0,25 MMOL/ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

GADOVIST 1,0 m mol/ml

1 mmol/l

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

69115 Heidelberg

Germany

Magnegita 500 mikromol/ml injekční roztok

0,5 mmo/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Bracco Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D-78467 Konstanz |
| Germany |

Bracco Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D-78467 Konstanz

Germany

ProHance

279,3 mg-ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Bracco Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D-78467 Konstanz |
| Germany |

Bracco Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D-78467 Konstanz

Germany

MultiHance

529 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, |
| P.O.Box 4220 |
| Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

Nycoveien 1-2,

P.O.Box 4220

Nydalen

N-0401 Oslo

Norway

Omniscan 0,5 mmol/l

287 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Guerbet |
| --- |
| BP 57400 |
| 95943 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95943 Roissy CdG cedex

France

Dotarem

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Repubblika Ċeka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MultiHance

529 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MultiHance

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Ġermanja

| BRACCO Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Strasse 116 |
| D - 78467 Konstanz |
| Germany |

BRACCO Imaging Deutschland GmbH

Max-Stromeyer-Strasse 116

D - 78467 Konstanz

Germany

MultiHance XL

529 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadovist 1,0 mmol/ml Injektioslösung

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadovist 1,0 mmol/ml Injektioslösung in Fertigspritzen/Patronen

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Marotrast GmbH |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Marotrast GmbH

Otto-Schott-Str. 15

D-07745 Jena

Germany

Gadograf 1,0 mmol/ml Injektionslösung in Fertigspritzen

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Marotrast GmbH |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Marotrast GmbH

Otto-Schott-Str. 15

D-07745 Jena

Germany

Gadograf 1,0 mmol/ml

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| GE Healthcare Buchler GmbH & Co.KG |
| --- |
| Gieselweg 1 |
| D-38110 Braunschweig |
| Germany |

GE Healthcare Buchler GmbH & Co.KG

Gieselweg 1

D-38110 Braunschweig

Germany

Omniscan 0,5 mmol/ml Injektioslösung

287 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| GE Healthcare Buchler GmbH & Co.KG |
| --- |
| Gieselweg 1 |
| D-38110 Braunschweig |
| Germany |

GE Healthcare Buchler GmbH & Co.KG

Gieselweg 1

D-38110 Braunschweig

Germany

Omniscan 0,5 mmol/ml Injektioslösung in Fertigspritzen

287 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Guerbet |
| --- |
| 15 rue des Vanesses |
| Zone Paris Nord II |
| F-83420 VILLEPINTE |
| France |

Guerbet

15 rue des Vanesses

Zone Paris Nord II

F-83420 VILLEPINTE

France

Dotarem 0,5 mmol/ml Injektionslösung in Fertigspritzen

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Guerbet |
| --- |
| 15 rue des Vanesses |
| Zone Paris Nord II |
| F-83420 VILLEPINTE |
| France |

Guerbet

15 rue des Vanesses

Zone Paris Nord II

F-83420 VILLEPINTE

France

Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen (für Mehrfachentnahme)

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Guerbet |
| --- |
| 15 rue des Vanesses |
| Zone Paris Nord II |
| F-83420 VILLEPINTE |
| France |

Guerbet

15 rue des Vanesses

Zone Paris Nord II

F-83420 VILLEPINTE

France

Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Magnevist 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadopentetat-Dimeglumin 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| be imaging GmbH |
| --- |
| Dr.-Rudolf-Eberle-Str. 8-10 |
| D-76534 Baden-Baden |
| Germany |

be imaging GmbH

Dr.-Rudolf-Eberle-Str. 8-10

D-76534 Baden-Baden

Germany

Magnevision 0,5 mmol/ml Injektionslösung

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Covidien Deutschland GmbH |
| --- |
| Gewerbepark 1 |
| D-93333 Neustadt |
| Germany |

Covidien Deutschland GmbH

Gewerbepark 1

D-93333 Neustadt

Germany

Marktiv 500 Mikromol/ml Injektionslösung

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| be imaging GmbH |
| --- |
| Dr.-Rudolf-Eberle-Str. 8-10 |
| D-76534 Baden-Baden |
| Germany |

be imaging GmbH

Dr.-Rudolf-Eberle-Str. 8-10

D-76534 Baden-Baden

Germany

Magnevision b.e. 0,5 mmol/ml Injektionslösung

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Helm AG |
| --- |
| Nordkanalstr. 28 |
| D-20097 Hamburg |
| Germany |

Helm AG

Nordkanalstr. 28

D-20097 Hamburg

Germany

Gadopentetat Dimeglumin Helm AG Injektionslösung

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita 500 Mikromol/ml Injektionslösung

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Gadopentetat Insight 500 Mikromol/ml Injektionslösung

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Marotrast GmbH |
| --- |
| Otto-Schott-Str. 15 |
| D-07745 Jena |
| Germany |

Marotrast GmbH

Otto-Schott-Str. 15

D-07745 Jena

Germany

Magnograf 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| D-89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

D-89079 Ulm

Germany

Gadopentetat-MRT-ratiopharm

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Sanochemia Diagnostics Deutschland GmbH |
| --- |
| Stresemannallee 4 c |
| D-41460 Neuss |
| Germany |

Sanochemia Diagnostics Deutschland GmbH

Stresemannallee 4 c

D-41460 Neuss

Germany

MR-Lux

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromexer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromexer-Str. 116

D-78467 Konstanz

Germany

ProHance

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Primovist 0,25 mml/ml Injektionslösung, Fertigspritze

181,43 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Primovist 0,25 mml/ml Injektionslösung, Durchstechflasche

181,43 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/mL

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Id-Danimarka

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

0,5 mmol/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Gadopentetat “Insight”

0,5 mmol/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist

1 mmol/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist PFS

1 mmol/mL

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Id-Danimarka

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance

279,3 mg/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/mL

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

Multihance

334 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Id-Danimarka

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

Multihance

334 mg

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Estonja

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

MAGNEVIST

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Estonja

| GE Healthcare AS |
| --- |
| PO 4220, Nycoveien 1-2 |
| NO-0401 Nydalen |
| Norway |

GE Healthcare AS

PO 4220, Nycoveien 1-2

NO-0401 Nydalen

Norway

OMNISCAN

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Estonja

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

GADOVIST

1 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Estonja

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Estonja

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Estonja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

MAGNEGITA

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| GE HEALTHCARE BIO-SCIENCES S.A. |
| --- |
| Avda. de Europa |
| 22 Alcobendas 28108 Madrid |
| Spain |

GE HEALTHCARE BIO-SCIENCES S.A.

Avda. de Europa

22 Alcobendas 28108 Madrid

Spain

OMNISCAN

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa

Użu għal ġol-vini

Spanja

| GE HEALTHCARE BIO-SCIENCES S.A. |
| --- |
| Avda. de Europa |
| 22 Alcobendas 28108 Madrid |
| Spain |

GE HEALTHCARE BIO-SCIENCES S.A.

Avda. de Europa

22 Alcobendas 28108 Madrid

Spain

OMNISCAN

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| Bracco S.p.A. |
| --- |
| Via Egido Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egido Folli, 50

20134 Milano

Italy

MULTIHANCE

0,5 M

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni (syringe)

Użu għal ġol-vini

Spanja

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

PROHANCE

(0,5 M)

Soluzzjoni għall-injezzjoni (syringe)

Użu għal ġol-vini

Spanja

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

PROHANCE

(0,5 M)

Soluzzjoni għall-injezzjoni (kunjett)

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

GADOVIST

1,0 mmol/ml

Soluzzjoni għall-injezzjoni (kunjett)

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

GADOVIST

1,0 mmol/ml

Soluzzjoni għall-injezzjoni (siringa, skartoċċ)

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNEVIST

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNEVIST

0,5 mmol/ml

Soluzzjoni għall-injezzjoni (syringe)

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNOGRAF

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| QUIMICA FARMACEUTICA BAYER S.L. |
| --- |
| Av. Baix Llobregat |
| 3-5 Sant Joan Despi |
| Barcelona 08970 |
| Spain |

QUIMICA FARMACEUTICA BAYER S.L.

Av. Baix Llobregat

3-5 Sant Joan Despi

Barcelona 08970

Spain

MAGNOGRAF

0,5 mmol/ml

Soluzzjoni għall-injezzjoni (syringe)

Użu għal ġol-vini

Spanja

| Guerbet |
| --- |
| BP 57400 |
| 95493 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95493 Roissy CdG cedex

France

Dotarem

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Spanja

| Guerbet |
| --- |
| BP 57400 |
| 95493 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95493 Roissy CdG cedex

France

Dotarem

0,5 mmol/ml

Soluzzjoni għall-injezzjoni (syringe)

Użu għal ġol-vini

Il-Finlandja

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

OMNISCAN

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47 |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47

20210 Turku

Finland

MAGNEVIST

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B, |
| 69115 HEIDELBERG |
| Germany |

Insight Agents GmbH

Ringstr. 19 B,

69115 HEIDELBERG

Germany

MAGNEGITA

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B, |
| 69115 HEIDELBERG |
| Germany |

Insight Agents GmbH

Ringstr. 19 B,

69115 HEIDELBERG

Germany

GADOPENTETATE INSIGHT

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MULTIHANCE

334 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MULTIHANCE

334 mg/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Finlandja

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Finlandja

| Bracco International B.V |
| --- |
| Strawinskylaan 3051, |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051,

NL-1077 ZX Amsterdam

Netherlands

PROHANCE

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

GADOVIST

1 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Finlandja

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

GADOVIST

1 mmol/ml

Soluzzjoni għall-injezzjoni (syringe)

Użu għal ġol-vini

Il-Finlandja

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| GE HEALTHCARE |
| --- |
| 11, avenue Morane Saulnier |
| 78140 Vélizy Villacoublay |
| France |

GE HEALTHCARE

11, avenue Morane Saulnier

78140 Vélizy Villacoublay

France

OMNISCAN 0,5 mmol/ml, solution injectable

28,7 g/100 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| GE HEALTHCARE |
| --- |
| 11, avenue Morane Saulnier |
| 78140 Vélizy Villacoublay |
| France |

GE HEALTHCARE

11, avenue Morane Saulnier

78140 Vélizy Villacoublay

France

OMNISCAN 0,5 mmol/ml, solution injectable en seringue pré-remplie

287 mg/1 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

MULTIHANCE 0,5 mmol/ml, solution injectable (IV)

529 mg/1 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

MULTIHANCE 0,5 mmol/ml, solution injectable en seringue pré-remplie

529 mg/1 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

MAGNEVIST, solution injectable (IV)

46,901 g/100 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

MAGNEVIST, solution injectable en seringue pré-remplie (IV)

46,901 g/100 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 1 396,5 mg/5 ml, solution injectable

1 396,50 mg/5 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 1 396,5 mg/5 ml, solution injectable en seringue pré-remplie

1 396,5 mg/5ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 2 793 mg/10 ml, solution injectable

2 793 mg/10 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 2 793 mg/10 ml, solution injectable en seringue pré-remplie

2 793 mg/10 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 4 189,5 mg/15 ml, solution injectable

4 189,50 mg/15 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 4 189,5 mg/15 ml, solution injectable en seringue pré-remplie

4 189,50 mg/15 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 4 748,10 mg/17 ml, solution injectable en seringue pré-remplie

4 748,1 mg/17 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| BRACCO IMAGING France |
| --- |
| 7, place Copernic |
| 91080 Courcouronnes |
| France |

BRACCO IMAGING France

7, place Copernic

91080 Courcouronnes

France

PROHANCE 5 586 mg/20 ml, solution injectable

5 586 mg/20 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

GADOVIST 1,0 mmol/mL, solution injectable

604,72 mg/1 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| BAYER SANTE |
| --- |
| 220, avenue de la Recherche |
| 59120 Loos |
| France |

BAYER SANTE

220, avenue de la Recherche

59120 Loos

France

GADOVIST 1,0 mmol/mL, solution injectable en seringue préremplie

604,72 mg/1 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Franza

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml, solution injectable en flacon

27,932 g/100 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Franza

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml, solution injectable en seringue pré-remplie

27,932 g/100 ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Greċja

| GE HEALTHCARE |
| --- |
| PLAPOUTA 139 & LAMIAS ST |
| NEO IRAKLEIO 14121 |
| GREECE |

GE HEALTHCARE

PLAPOUTA 139 & LAMIAS ST

NEO IRAKLEIO 14121

GREECE

OMNISCAN

287 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS, GREECE

MAGNEVIST

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

| GEROLYMATOS P.G.N. AEBE |
| --- |
| ASKLIPIOU ST KRYONERI |
| ATTICA |
| GREECE |

GEROLYMATOS P.G.N. AEBE

ASKLIPIOU ST KRYONERI

ATTICA

GREECE

MULTIHANCE

529 mg/mlm

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

| GEROLYMATOS P.G.N. AEBE |
| --- |
| ASKLIPIOU ST KRYONERI |
| ATTICA |
| GREECE |

GEROLYMATOS P.G.N. AEBE

ASKLIPIOU ST KRYONERI

ATTICA

GREECE

MULTIHANCE

529 mg/mlm

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Greċja

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

PRIMOVIST “PFS”

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Greċja

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

GADOVIST

1 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

| BAYER HELLAS ABEE |
| --- |
| SOROU 18-20, |
| 151 25 MAROUSI, ATHENS, |
| GREECE |

BAYER HELLAS ABEE

SOROU 18-20,

151 25 MAROUSI, ATHENS,

GREECE

GADOVIST PFS

1 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Greċja

| Hospital Line SA |
| --- |
| K. Palama 36 |
| GR-143 43, N. Chalkidona, Athens |
| Greece |

Hospital Line SA

K. Palama 36

GR-143 43, N. Chalkidona, Athens

Greece

Dotarem

1,4 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Greċja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

VASOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 15ml

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 20ml

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 60ml

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml injection 100ml

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

GADOVIST 1,0 mmol/ml solution for injection

1 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

GADOVIST

1 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Ungerija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

MAGNEVIST

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

MAGNEVIST

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Ungerija

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MULTIHANCE

0,5 M

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

OMNISCAN 0,5 mmol/ml injection

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Ungerija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

PRIMOVIST

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Irlanda

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmol/ml solution for injection, glass vial/bottle

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmol/ml solution for injection, polypropylene bottles

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmol/ml solution for injection, prefilled syringe

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Primovist 0,25 mmol/ml Sol for Injection

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Primovist 0,25 mmol/ml Sol for Injection, prefilled syringe

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Gadovist 1,0 mmol/ml Solution for Injection

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Gadovist 1,0 mmol/ml Solution for Injection in prefilled syringe

1,0 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Gadovist 1,0 mmol/ml Solution for Injection in prefilled cartridge

1,0 mmol/ml

Soluzzjoni għall-injezzjoni, Skartoċċ

Użu għal ġol-vini

L-Irlanda

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 5 ml vial

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 10 ml vial

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 15 ml vial

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance 279,3 mg/ml Solution for Injection, 20 ml vial

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem 279,32 mg/ml Solution for Injection, glass pre-filled syringes

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem 279,32 mg/ml Solution for Injection, glass vials

279,32 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance 0,5 M solution for injection

529 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance 529 mg/ml solution for injection in prefiled syringe

529 mg/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Irlanda

| Insights Agents GmbH |
| --- |
| Ringstrasse 19B |
| D-69115 Heidelberg |
| Germany |

Insights Agents GmbH

Ringstrasse 19B

D-69115 Heidelberg

Germany

Magnegita 500 micromol/ml solution for injection

500 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Magnevist 0,5 mmol/ml Solution for Injection

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road |
| Dublin 18 |
| Ireland |

Bayer Limited

The Atrium

Blackthorn Road

Dublin 18

Ireland

Magnevist 0,5 mmol/ml Solution for Injection in pre-filled syringe.

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-islanda

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-islanda

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-islanda

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-islanda

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

0,0025 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| GE Healthcare |
| --- |
| Via Galeno 36, |
| 20126 Milano |
| Italy |

GE Healthcare

Via Galeno 36,

20126 Milano

Italy

Omniscan

287 mg/ml (0,5 mmol/ml)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| Bracco Imaging Italia |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco Imaging Italia

Via Egidio Folli, 50

20134 Milano

Italy

ProHance

279,3 mg/ml (0,5 M)

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

L-Italja

| Bracco Imaging Italia |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco Imaging Italia

Via Egidio Folli, 50

20134 Milano

Italy

MultiHance

334 mg/ml (0,5 M)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| Bayer SpA |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italy |

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Gadovist

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Italja

| Bayer SpA |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italy |

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Litwanja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Gadovist

1 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Litwanja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Litwanja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Litwanja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Magnevist

0,5 mmol/ml

Soluzzjoni għall-injezzjoni/infużjoni

Użu għal ġol-vini

Il-Litwanja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Litwanja

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O. Box 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Codali S.A. |
| --- |
| Avenue Henri Dunant 31 |
| 1140 Bruxelles |
| Belgium |

Codali S.A.

Avenue Henri Dunant 31

1140 Bruxelles

Belgium

DOTAREM

37,7 G

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

GADOPENTETATE INSIGHT

469 MG/ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

GADOVIST 1

604,72 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

GADOVIST PFS-1

604,72 mg/1 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

MAGNEGITA

78,63 MG/1 ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Bayer SA-NV |
| --- |
| J.E. Mommaertslaan 14 |
| 1831 Diegem |
| Belgium |

Bayer SA-NV

J.E. Mommaertslaan 14

1831 Diegem

Belgium

MAGNEVIST

4,69 G/10 ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

MULTIHANCE

529 mg/1 ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| GE HEALTHCARE BVBA |
| --- |
| Kouterveldstraat 20 |
| 1831 DIEGEM |
| Belgium |

GE HEALTHCARE BVBA

Kouterveldstraat 20

1831 DIEGEM

Belgium

OMNISCAN

287 MG/1 ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Lussemburgu

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

PROHANCE

279,3 MG/1 ML

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist 1,0 mmol/ml solution for injections

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita 500 micromol/ml solution for injection

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist 0,5 mmol/ml solution for injection

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan 0,5 mmmol/ml solution for injection

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml solution for injection

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Latvja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml solution for injection pre-filled syringe

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Malta

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mMol/ml (287 mg equiv. 0,5 mmol)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Malta

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Magnevist

469,01 mg

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Malta

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Primovist

PFS 0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Olanda

| Guerbet Nederland B.V. |
| --- |
| Avelingen-West 3A |
| 4202 MS GORINCHEM |
| Netherlands |

Guerbet Nederland B.V.

Avelingen-West 3A

4202 MS GORINCHEM

Netherlands

Dotarem

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Gadovisit

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Magnevist

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

Multihance

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| GE Healthcare B.V. |
| --- |
| Cygne Centre De Rondom 8 |
| 5612 AP EINDHOVEN |
| Netherlands |

GE Healthcare B.V.

Cygne Centre De Rondom 8

5612 AP EINDHOVEN

Netherlands

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

Prohance

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Olanda

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Gadopentetate Insight

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

MultiHance

334 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| Bracco International B.V |
| --- |
| Strawinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| Netherlands |

Bracco International B.V

Strawinskylaan 3051

NL-1077 ZX Amsterdam

Netherlands

Prohance

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Gadovist

1 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

In-Norveġja

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

4220 Nydalen,

Oslo N-0401

Norway

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O. Box 4220 Nydalen, |
| Oslo NO-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen,

Oslo NO-0401

Norway

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| Bracco Imaging Deutschland GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco Imaging Deutschland GmbH

Max-Stromeyer-Str. 116

D-78467 Konstanz

Germany

ProHance

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Gadovist 1,0

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| Bracco ALTANA Pharma GmbH |
| --- |
| Max-Stromeyer-Str. 116 |
| 78467 Konstanz |
| Germany |

Bracco ALTANA Pharma GmbH

Max-Stromeyer-Str. 116

78467 Konstanz

Germany

Multihance

529 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Polonja

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| Bayer Portugal S.A. |
| --- |
| Rua Quinta do Pinheiro, 5 |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal S.A.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugal

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| Bayer Portugal S.A. |
| --- |
| Rua Quinta Pinheiro, 5, |
| 2794-003 Carnaxide |
| Portugal |

Bayer Portugal S.A.

Rua Quinta Pinheiro, 5,

2794-003 Carnaxide

Portugal

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Portugall

| Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda. |
| --- |
| Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide |
| Portugal |

Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda.

Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide

Portugal

Gadovist

1 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda. |
| --- |
| Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide |
| Portugal |

Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda.

Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide

Portugal

Gadovist

1 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Il-Portugall

| A. Martins & Fernandes S.A. |
| --- |
| Rua Raúl Mesnier du Ponsard, |
| 4 B 1750-243 Lisboa |
| Portugal |

A. Martins & Fernandes S.A.

Rua Raúl Mesnier du Ponsard,

4 B 1750-243 Lisboa

Portugal

Dotarem

377 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Il-Portugall

| Satis-Radioisótopos e Protecções Contra Sobretensões Eléctricas Unipessoal Lda. |
| --- |
| Edifício Ramazzotti, Av. do Forte, |
| n.o 6 - 6A, 2790-502 Carnaxide |
| Portugal |

Satis-Radioisótopos e Protecções Contra Sobretensões Eléctricas Unipessoal Lda.

Edifício Ramazzotti, Av. do Forte,

n.o 6 - 6A, 2790-502 Carnaxide

Portugal

Omniscan

287 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| Bracco S.p.A. |
| --- |
| Via Egidio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Egidio Folli, 50

20134 Milano

Italy

MULTIHANCE 0,5M

0,529 g (0,334 g + 0,195 g) / ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-

Germany

MAGNEVIST

469,01 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| INSIGHT AGENTS GmbH |
| --- |
| Ringstrasse. 19B |
| 69115 Heidelberg |
| Germany |

INSIGHT AGENTS GmbH

Ringstrasse. 19B

69115 Heidelberg

Germany

MAGNEGITA 500 micromol/ml, soluție injectabilă

500 micromol/ml (469,01 mg/ml)

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml soluție injectabilă în seringă preumplută

27,932 g/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Ir-Rumanija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml soluție injectabilă unidoză

27,932 g/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

DOTAREM 0,5 mmol/ml soluție injectabilă multidoză

27,932 g/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-

Germany

PRIMOVIST 0,25 mmol/ml, soluție injectabilă în seringă preumplută

181,430 mg/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Ir-Rumanija

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-

Germany

GADOVIST 1,0 mmol/ml, soluție injectabilă

604,720 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Rumanija

| GE Healthcare AS |
| --- |
| Nycoveien 1-2 |
| P.O. Box 4220 Nydalen, |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

Nycoveien 1-2

P.O. Box 4220 Nydalen,

N-0401 Oslo

Norway

OMNISCAN, soluție injectabilă

287,000 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-Wedding

Germany

Magnevist

0,5 mmol/m

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance

334 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bracco SpA |
| --- |
| Via Egidio. Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio. Folli 50

I-20134 Milan

Italy

Multihance

334 mg/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Isvezja

| Bracco International BV |
| --- |
| Stravinskylaan 3051 |
| NL-1077 ZX Amsterdam |
| The Netherlands |

Bracco International BV

Stravinskylaan 3051

NL-1077 ZX Amsterdam

The Netherlands

Prohance

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| GE Healthcare AS |
| --- |
| P.O.Box 4220 |
| Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

P.O.Box 4220

Nydalen

N-0401 Oslo

Norway

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| GE Healthcare AS |
| --- |
| P.O.Box 4220 |
| Nydalen |
| N-0401 Oslo |
| Norway |

GE Healthcare AS

P.O.Box 4220

Nydalen

N-0401 Oslo

Norway

Omniscan

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG, |
| --- |
| Müllerstrasse 178 |
| DE-133 42 Berlin |
| Germany |

Bayer Schering Pharma AG,

Müllerstrasse 178

DE-133 42 Berlin

Germany

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG, |
| --- |
| Müllerstrasse 178 |
| DE-133 42 Berlin |
| Germany |

Bayer Schering Pharma AG,

Müllerstrasse 178

DE-133 42 Berlin

Germany

Primovist

0,25 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Isvezja

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178,

DE-13342 Berlin-Wedding

Germany

Gadovist

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178,

DE-13342 Berlin-Wedding

Germany

Gadovist

1,0 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

L-Isvezja

| Insight Agents GmbH |
| --- |
| Ringstr.19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr.19 B

D-69115 Heidelberg

Germany

Magnegita

500 mikromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Insight Agents GmbH |
| --- |
| Ringstr.19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr.19 B

D-69115 Heidelberg

Germany

Gadopentetsyrad imegluminat Insight

500 mikromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-Wedding

Germany

Magnograf

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

L-Isvezja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13342 Berlin-Wedding

Germany

Magnograf

0,5 mmol/ml

Soluzzjoni għall-injezzjoni, siringa mimlija għal-lest

Użu għal ġol-vini

Slovenja

| Higieia d.o.o. |
| --- |
| Zastopstva in trgovina, Blatnica 10, |
| 1236 Trzin, |
| Slovenia |

Higieia d.o.o.

Zastopstva in trgovina, Blatnica 10,

1236 Trzin,

Slovenia

Omniscan 0,5 mmol/ml raztopina za injiciranje

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Slovenja

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnetita 500 mikromolov/ml raztopina za injiciranje

500 micromol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Slovenja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178 |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178

DE-13342 Berlin-Wedding

Germany

Magnevist

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Slovenja

| Auremiana |
| --- |
| izvozno uvozno trgovsko podjetje, d.o.o., Sežana, Partizanska 109, 6210 Sežana |

Auremiana

izvozno uvozno trgovsko podjetje, d.o.o., Sežana, Partizanska 109, 6210 Sežana

Multihance 0,5 mmol/ml raztopina za injiciranje

334 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Slovenja

| Emporio Medical |
| --- |
| d.o.o., Prešernova 5, 1000 Ljubljana, |
| Slovenia |

Emporio Medical

d.o.o., Prešernova 5, 1000 Ljubljana,

Slovenia

Dotarem 0,5 mmol/ml raztopina za injiciranje

27,93 g/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Slovenja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Gadovist 1,0 mmol/ml raztopina za injiciranje

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Slovenja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml raztopina za injiciranje v napolnjeni injekcijski brizgi

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Is-Slovakkja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Gadovist 1,0 mmol/ml

604,72 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Is-Slovakkja

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

OMNISCAN

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Is-Slovakkja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Primovist 0,25 mmol/ml, injekčný roztok

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Is-Slovakkja

| Bracco IMAGING Deutschland GmbH |
| --- |
| Max-Stromexer-Str. 116 |
| D-78467 Konstanz |
| Germany |

Bracco IMAGING Deutschland GmbH

Max-Stromexer-Str. 116

D-78467 Konstanz

Germany

PROHANCE

279,3 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Is-Slovakkja

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 170-178, |
| DE-13342 Berlin-Wedding |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 170-178,

DE-13342 Berlin-Wedding

Germany

Magnevist

469 mg/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| GE Healthcare AS |
| --- |
| Nycoveien 1-2, 4220 Nydalen, |
| Oslo N-0401 |
| Norway |

GE Healthcare AS

Nycoveien 1-2, 4220 Nydalen,

Oslo N-0401

Norway

Omniscan injection

0,5 mmol/ml and 0,5 mmol/litre

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Magnevist

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| Bracco S.p.A. |
| --- |
| Via Emilio Folli, 50 |
| 20134 Milano |
| Italy |

Bracco S.p.A.

Via Emilio Folli, 50

20134 Milano

Italy

Multihance

0,5 M/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, |
| Newbury, Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill,

Newbury, Berkshire, RG14 1JA

UK

Primovist solution for injection

0,25 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| Bracco International B.V., |
| --- |
| Strawinskylaan 3051 |
| Amsterdam 107 zx |
| Netherlands |

Bracco International B.V.,

Strawinskylaan 3051

Amsterdam 107 zx

Netherlands

Prohance

0,5 M/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| Bayer plc |
| --- |
| Bayer House, Strawberry Hill, Newbury, |
| Berkshire, RG14 1JA |
| UK |

Bayer plc

Bayer House, Strawberry Hill, Newbury,

Berkshire, RG14 1JA

UK

Gadovist

1,0 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

Ir-Renju Unit

| GUERBET |
| --- |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem solution for injection

0,5 mmol/ml

Soluzzjoni għall-injezzjoni

Użu għal ġol-vini

---

ANNESS VI

LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTUR(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/EE | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem (Ivvintat) | Qawwa | Ghamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien, |
| L-Awstrija |

Stat Membru UE/EE

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem (Ivvintat)

Qawwa

Ghamla Farmaċewtika

Mnejn jingħata

L-Awstrija

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien,

L-Awstrija

Valtrex 1 000 mg - Filmtabletten

1 000 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| L-Awstrija |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

L-Awstrija

Valaciclovir Sandoz 1 000 mg - Filmtabletten

1 000 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| L-Awstrija |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

L-Awstrija

Valtrex 500 mg - Filmtabletten

500 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| L-Awstrija |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

L-Awstrija

Valaciclovir Sandoz 500 mg - Filmtabletten

500 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien, |
| L-Awstrija |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien,

L-Awstrija

Valtrex 250 mg - Filmtabletten

250 mg

pillola miksija b’rita

Użu orali

L-Awstrija

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| L-Awstrija |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

L-Awstrija

Valaciclovir Sandoz 250 mg - Filmtabletten

250 mg

pillola miksija b’rita

Użu orali

Il-Belġju

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Il-Belġju

Zelitrex

500 mg

pillola miksija b’rita

Użu orali

Il-Belġju

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Il-Belġju

Zelitrex

250 mg

pillola miksija b’rita

Użu orali

Il-Bulgarija

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| Ir-Renju Unit |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Ċipru

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex, UB6 0NN, |
| Ir-Renju Unit |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex, UB6 0NN,

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Ir-Repubblika Ċeka

| The Wellcome Foundation Ltd., Glaxo Wellcome House |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| Ir-Renju Unit |

The Wellcome Foundation Ltd., Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

Ir-Renju Unit

Valtrex 500 mg

500 mg

pillola miksija b’rita

Użu orali

Id-Danimarka

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Id-Danimarka |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Id-Danimarka

Zelitrex

1 000 mg

pillola miksija b’rita

Użu orali

Id-Danimarka

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Id-Danimarka |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Id-Danimarka

Zelitrex

500 mg

pillola miksija b’rita

Użu orali

Id-Danimarka

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Id-Danimarka |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Id-Danimarka

Zelitrex

250 mg

pillola miksija b’rita

Użu orali

L-Estonja

| Glaxo Wellcome Operations |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN, |
| Ir-Renju Unit |

Glaxo Wellcome Operations

Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN,

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Finlandja

| The Wellcome Foundation Ltd. Greenford, |
| --- |
| Middlesex, |
| Ir-Renju Unit |

The Wellcome Foundation Ltd. Greenford,

Middlesex,

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Finlandja

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo, |
| Il-Finlandja |

Orion Corporation

Orionintie 1

FI-02200 Espoo,

Il-Finlandja

Valavir

500 mg

pillola miksija b’rita

Użu orali

Il-Finlandja

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A, |
| 02230 Espoo, |
| Il-Finlandja |

GlaxoSmithKline Oy

Piispansilta 9 A,

02230 Espoo,

Il-Finlandja

Valtrex

250 mg

pillola miksija b’rita

Użu orali

Franza

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, Franza |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, Franza

Zelitrex 500 mg, comprimé enrobé

500 mg

pillola miksija b’rita

Użu orali

Franza

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, Franza |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, Franza

Zelitrex 1 000 mg, comprimé enrobé

1 000 mg

pillola miksija b’rita

Użu orali

Franza

| Laboratoires BIOGARAN 15, boulevard Charles de Gaulle |
| --- |
| 92707 COLOMBES Cedex |
| Franza |

Laboratoires BIOGARAN 15, boulevard Charles de Gaulle

92707 COLOMBES Cedex

Franza

Valaciclovir Biogaran 500 mg, comprimé enrobé

500 mg

pillola miksija b’rita

Użu orali

Franza

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, Franza |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, Franza

Valaciclovir GSK 500 mg, comprimé enrobé

500 mg

pillola miksija b’rita

Użu orali

Franza

| sanofi-aventis France |
| --- |
| 1 – 13 boulevard Romain Rolland |
| 75014 PARIS |
| Franza |

sanofi-aventis France

1 – 13 boulevard Romain Rolland

75014 PARIS

Franza

Valaciclovir Winthrop 500 mg, comprimé enrobé

500 mg

pillola miksija b’rita

Użu orali

Il-Ġermanja

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Il-Ġermanja |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Il-Ġermanja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Ġermanja

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Il-Ġermanja |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Il-Ġermanja

Valtrex S

500 mg

pillola miksija b’rita

Użu orali

Il-Ġermanja

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Il-Ġermanja |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Il-Ġermanja

Valtrex S 250 mg

250 mg

pillola miksija b’rita

Użu orali

Il-Greċja

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Il-Greċja |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Il-Greċja

Valtrex

1 000 mg

pillola miksija b’rita

Użu orali

Il-Greċja

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Il-Greċja |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Il-Greċja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Greċja

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Il-Greċja |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Il-Greċja

Valtrex

250 mg

pillola miksija b’rita

Użu orali

L-Islanda

| GlaxoSmithKline ehf. |
| --- |
| Þverholt 14 |
| 105 Reykjavík, |
| L-Islanda |

GlaxoSmithKline ehf.

Þverholt 14

105 Reykjavík,

L-Islanda

Valtrex

500 mg

pillola miksija b’rita

Użu orali

L-Islanda

| GlaxoSmithKline ehf. |
| --- |
| Þverholt 14 |
| 105 Reykjavík, |
| L-Islanda |

GlaxoSmithKline ehf.

Þverholt 14

105 Reykjavík,

L-Islanda

Valtrex

250 mg

pillola miksija b’rita

Użu orali

L-Irlanda

GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, L-Irlanda

Valtrex 500 mg Film-coated Tablet

500 mg

pillola miksija b’rita

Użu orali

L-Irlanda

GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, L-Irlanda

Valtrex 250 mg Film-coated Tablet

250 mg

pillola miksija b’rita

Użu orali

L-Italja

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| L-Italja |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

L-Italja

Zelitrex

1 000 mg

pillola miksija b’rita

Użu orali

L-Italja

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| L-Italja |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

L-Italja

Talavir

1 000 mg

pillola miksija b’rita

Użu orali

L-Italja

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| L-Italja |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

L-Italja

Zelitrex

500 mg

pillola miksija b’rita

Użu orali

L-Italja

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| L-Italja |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

L-Italja

Talavir

500 mg

pillola miksija b’rita

Użu orali

L-Italja

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| L-Italja |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

L-Italja

Zelitrex

250 mg

pillola miksija b’rita

Użu orali

L-Italja

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| L-Italja |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

L-Italja

Talavir

250 mg

pillola miksija b’rita

Użu orali

Il-Latvja

| GlaxoSmithKline Latvia SIA, Bruņinieku iela 5, |
| --- |
| Riga, LV-1001 |
| L-Italja |

GlaxoSmithKline Latvia SIA, Bruņinieku iela 5,

Riga, LV-1001

L-Italja

Valtrex 500 mg film-coated tablets

500 mg

pillola miksija b’rita

Użu orali

Il-Litwanja

| The Wellcome Foundation Ltd, |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, |
| Greenford, |
| Middlesex UB6 0NN, |
| Ir-Renju Unit |

The Wellcome Foundation Ltd,

Glaxo Wellcome House, Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Lussemburgu

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Il-Belġju

Zelitrex

500 mg

pillola miksija b’rita

Użu orali

Il-Lussemburgu

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Il-Belġju

Zelitrex

250 mg

pillola miksija b’rita

Użu orali

Malta

| The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, |
| --- |
| Middlesex, UB6 ONN, |
| Ir-Renju Unit |

The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford,

Middlesex, UB6 ONN,

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

L-Olanda

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZZeist, |
| L-Olanda |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZZeist,

L-Olanda

Zelitrex 500 mg

500 mg

pillola miksija b’rita

Użu orali

L-Olanda

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist, |
| L-Olanda |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZ Zeist,

L-Olanda

Zelitrex 250 mg

250 mg

pillola miksija b’rita

Użu orali

In-Norveġja

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| In-Norveġja |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

In-Norveġja

Valtrex

1 000 mg

pillola miksija b’rita

Użu orali

In-Norveġja

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| In-Norveġja |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

In-Norveġja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

In-Norveġja

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| In-Norveġja |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

In-Norveġja

Valtrex

250 mg

pillola miksija b’rita

Użu orali

Il-Polonja

| GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex, |
| --- |
| TW8 9GS |
| Ir-Renju Unit |

GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex,

TW8 9GS

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Portugall

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Il-Portugall |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Il-Portugall

Valtrex

1 000 mg

pillola miksija b’rita

Użu orali

Il-Portugall

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Il-Portugall |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Il-Portugall

Valavir

1 000 mg

pillola miksija b’rita

Użu orali

Il-Portugall

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Il-Portugall |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Il-Portugall

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Il-Portugall

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Il-Portugall |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Il-Portugall

Valavir

500 mg

pillola miksija b’rita

Użu orali

Il-Portugall

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Il-Portugall |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Il-Portugall

Valtrex

250 mg

pillola miksija b’rita

Użu orali

Il-Portugall

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Il-Portugall |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Il-Portugall

Valavir

250 mg

pillola miksija b’rita

Użu orali

Ir-Rumanija

| The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue, |
| --- |
| Greenford, |
| Middlesex UB6 0NN, |
| Ir-Renju Unit |

The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Is-Slovakkja

| GlaxoSmithKline Slovakia s.r.o., |
| --- |
| Galvaniho 7/A, |
| 82104 Bratislava |
| Is-Slovakkja |

GlaxoSmithKline Slovakia s.r.o.,

Galvaniho 7/A,

82104 Bratislava

Is-Slovakkja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Slovenja

| GSK do.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| 1001 Ljubljana |
| Slovenja |

GSK do.o., Ljubljana

Knezov štradon 90

1001 Ljubljana

Slovenja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Spanja

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Valtrex

1 000 mg

pillola miksija b’rita

Użu orali

Spanja

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Virval

1 000 mg

pillola miksija b’rita

Użu orali

Spanja

| Allen Farmacéutica S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

Allen Farmacéutica S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Valaciclovir Allen

1 000 mg

pillola miksija b’rita

Użu orali

Spanja

| Smithkline Beecham Farma S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

Smithkline Beecham Farma S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Valherpes

1 000 mg

pillola miksija b’rita

Użu orali

Spanja

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Spanja

| GlaxoSmithKline, S.A Severo Ochoa, 2, 28760, |
| --- |
| Tres Cantos Madrid |
| Spanja |

GlaxoSmithKline, S.A Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Virval

500 mg

pillola miksija b’rita

Użu orali

Spanja

| Allen Farmacéutica S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

Allen Farmacéutica S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Valaciclovir Allen

500 mg

pillola miksija b’rita

Użu orali

Spanja

| Smithkline Beecham Farma S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanja |

Smithkline Beecham Farma S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanja

Valherpes

500 mg

pillola miksija b’rita

Użu orali

L-Isvezja

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| L-Isvezja |

GlaxoSmithKline AB

Box 516

169 29 Solna,

L-Isvezja

Valtrex

1 g

pillola miksija b’rita

Użu orali

L-Isvezja

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| L-Isvezja |

GlaxoSmithKline AB

Box 516

169 29 Solna,

L-Isvezja

Valtrex

500 mg

pillola miksija b’rita

Użu orali

L-Isvezja

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| L-Isvezja |

GlaxoSmithKline AB

Box 516

169 29 Solna,

L-Isvezja

Valtrex

250 mg

pillola miksija b’rita

Użu orali

Ir-Renju Unit

| The Wellcome Foundation Ltd |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| Ir-Renju Unit |

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

Ir-Renju Unit

Trading as;

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| Ir-Renju Unit |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Ir-Renju Unit

Valtrex

500 mg

pillola miksija b’rita

Użu orali

Ir-Renju Unit

| The Wellcome Foundation Ltd |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| Ir-Renju Unit |

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

Ir-Renju Unit

Trading as;

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| Ir-Renju Unit |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Ir-Renju Unit

Valtrex

250 mg

pillola miksija b’rita

Użu orali

---

ANNESS VII

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DENTENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Novartis Pharma GmbH |
| Brunner Strasse 59 |
| 1235 Wien |
| L-Awstrija |

Stat Membru UE/ŻEE

Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

L-Awstrija

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

L-Awstrija

Famvir 125 mg – Filmtabletten

125 mg

Pilloli miksija b’rita

Użu orali

L-Awstrija

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| L-Awstrija |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

L-Awstrija

Famvir 250 mg – Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

L-Awstrija

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| L-Awstrija |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

L-Awstrija

Famvir 500 mg – Filmtabletten

500 mg

Pilloli miksija b’rita

Użu orali

Ċipru

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kasou P.O. Box 23490 |
| Nicosia |
| Ċipru |

Demetriades & Papaellinas Ltd

21 Kasou P.O. Box 23490

Nicosia

Ċipru

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Ċipru

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kasou P.O. Box 23490 |
| Nicosia |
| Ċipru |

Demetriades & Papaellinas Ltd

21 Kasou P.O. Box 23490

Nicosia

Ċipru

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

Id-Danimarka

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Id-Danimarka |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Id-Danimarka

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Id-Danimarka

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Id-Danimarka |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Id-Danimarka

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

Il-Finlandja

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Il-Finlandja |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Il-Finlandja

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Il-Finlandja

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Il-Finlandja |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Il-Finlandja

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

Il-Finlandja

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Il-Finlandja |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Il-Finlandja

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2 - 4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| Franza |

Novartis Pharma S.A.S.

2 - 4, rue Lionel Terray

92500 Rueil-Malmaison

Franza

Oravir

125 mg

Pilloli miksija b’rita

Użu orali

Franza

| Novartis Pharma S.A.S. |
| --- |
| 2 - 4, rue Lionel Terray |
| 92500 Rueil-Malmison |
| Franza |

Novartis Pharma S.A.S.

2 - 4, rue Lionel Terray

92500 Rueil-Malmison

Franza

Oravir

500 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Il-Ġermanja |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Il-Ġermanja

Famvir 125 mg Filmtabletten

125 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Il-Ġermanja |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Il-Ġermanja

Famvir 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Il-Ġermanja |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Il-Ġermanja

Famvir Zoster 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Il-Ġermanja |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Il-Ġermanja

Famciclovir-Sandoz 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Il-Ġermanja |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Il-Ġermanja

Famciclovir-Sandoz 500 mg Filmtabletten

500 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Il-Ġermanja |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Il-Ġermanja

Famciclovir-SB 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Il-Ġermanja |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Il-Ġermanja

Famciclovir-SB Zoster 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Il-Greċja |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Il-Greċja

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Il-Greċja |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Il-Greċja

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Il-Greċja |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Il-Greċja

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungaria Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| L-Ungerija |

Novartis Hungaria Kft.

Bartók Béla út 43-47

H-1114 Budapest

L-Ungerija

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

L-Ungerija

| Novartis Hungaria Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| L-Ungerija |

Novartis Hungaria Kft.

Bartók Béla út 43-47

H-1114 Budapest

L-Ungerija

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Id-Danimarka L-Islanda |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Id-Danimarka L-Islanda

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

L-Islanda

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Id-Danimarka L-Islanda |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Id-Danimarka L-Islanda

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

750 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| L-Italja |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

L-Italja

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| L-Italja |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

L-Italja

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| L-Italja |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

L-Italja

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| L-Italja |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

L-Italja

Famciclovir Sandoz

125 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| L-Italja |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

L-Italja

Famciclovir Sandoz

250 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| L-Italja |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

L-Italja

Famciclovir Sandoz

500 mg

Pilloli miksija b’rita

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Il-Ġermanja |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Il-Ġermanja

Famvir 125 mg Filmtabletten

125 mg

Pilloli miksija b’rita

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Il-Ġermanja |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Il-Ġermanja

Famvir 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Il-Lussemburgu

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Il-Ġermanja |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Il-Ġermanja

Famvir Zoster 250 mg Filmtabletten

250 mg

Pilloli miksija b’rita

Użu orali

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

L-Olanda

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| L-Olanda |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

L-Olanda

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

L-Olanda

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| L-Olanda |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

L-Olanda

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

L-Olanda

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| L-Olanda |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

L-Olanda

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanja |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanja

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanja |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanja

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanja |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanja

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanja |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanja

Famvir

750 mg

Pilloli miksija b’rita

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| L-Isvezja |

Novartis Sverige AB

Box 1150

183 11 Täby

L-Isvezja

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| L-Isvezja |

Novartis Sverige AB

Box 1150

183 11 Täby

L-Isvezja

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

L-Isvezja

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| L-Isvezja |

Novartis Sverige AB

Box 1150

183 11 Täby

L-Isvezja

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

250 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

125 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

500 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Ir-Renju Unit |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Ir-Renju Unit

Famvir

750 mg

Pilloli miksija b’rita

Użu orali

---

ANNESS VIII

LISTA TA’ L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT(I), ID-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU | Id-Detentur ta’ l'Awtorizzazzjoni għat-tqegħid fis-suq | Isem (Ivvintat) | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Roche Austria GmbH, |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| L-Awstrija |

Stat Membru EU

Id-Detentur ta’ l'Awtorizzazzjoni għat-tqegħid fis-suq

Isem (Ivvintat)

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

L-Awstrija

Inhibace “Roche” 0,5 mg - Filmtabletten

0,5 mg

Pilloli miksija b’rita

Użu orali

L-Awstrija

| Roche Austria GmbH, |
| --- |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| L-Awstrija |

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

L-Awstrija

Inhibace “Roche” 2,5 mg - Filmtabletten

2,5 mg

Pilloli miksija b’rita

Użu orali

L-Awstrija

| Roche Austria GmbH, |
| --- |
| Engelhorngasse 3, |
| A - 1211 Vienna |
| L-Awstrija |

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 Vienna

L-Awstrija

Inhibace “Roche” 5 mg - Filmtabletten

5 mg

Pilloli miksija b’rita

Użu orali

Il-Belġju

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Il-Belġju |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Il-Belġju

Inhibace

0,5 mg

Pilloli miksija b’rita

Użu orali

Il-Belġju

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Il-Belġju |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Il-Belġju

Inhibace

5 mg

Pilloli miksija b’rita

Użu orali

Il-Bulgarija

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Il-Bulgarija |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Il-Bulgarija

Inhibace

1 mg

Pilloli miksija b’rita

Użu orali

Il-Bulgarija

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Il-Bulgarija |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Il-Bulgarija

Inhibace

2,5 mg

Pilloli miksija b’rita

Użu orali

Il-Bulgarija

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Il-Bulgarija |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Il-Bulgarija

Inhibace

5 mg

Pilloli miksija b’rita

Użu orali

Ir-Repubblika Ċeka

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Ir-Repubblika Ċeka |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Ir-Repubblika Ċeka

Inhibace 2,5 mg

2,5 mg

Pilloli miksija b’rita

Użu orali

Ir-Repubblika Ċeka

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Ir-Repubblika Ċeka |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Ir-Repubblika Ċeka

Inhibace 5 mg

5 mg

Pilloli miksija b’rita

Użu orali

Franza

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| Franza |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

Franza

Justor 0,5 mg

0,5 mg

Pilloli miksija b’rita

Użu orali

Franza

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| Franza |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

Franza

Justor 1 mg

1 mg

Pilloli miksija b’rita

Użu orali

Franza

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| Franza |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

Franza

Justor 2,5 mg

2,5 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Il-Ġermanja |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Il-Ġermanja

Dynorm 0,5

0,5 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Il-Ġermanja |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Il-Ġermanja

Dynorm 1,0

1 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Il-Ġermanja |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Il-Ġermanja

Dynorm 2,5

2,5 mg

Pilloli miksija b’rita

Użu orali

Il-Ġermanja

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Il-Ġermanja |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Il-Ġermanja

Dynorm 5,0

5 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Il-Greċja |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Il-Greċja

Vascace

0,5 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Il-Greċja |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Il-Greċja

Vascace

1 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Il-Greċja |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Il-Greċja

Vascace

2,5 mg

Pilloli miksija b’rita

Użu orali

Il-Greċja

| Roche (Hellas) SA |
| --- |
| 4, Alamanas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Il-Greċja |

Roche (Hellas) SA

4, Alamanas & Delfon Str.

Maroussi 15125

Attiki

Il-Greċja

Vascace

5 mg

Pilloli miksija b’rita

Użu orali

L-Ungerija

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| L-Ungerija |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

L-Ungerija

Inhibace

1 mg

Pilloli miksija b’rita

Użu orali

L-Ungerija

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| L-Ungerija |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

L-Ungerija

Inhibace

2,5 mg

Pilloli miksija b’rita

Użu orali

L-Ungerija

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| L-Ungerija |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

L-Ungerija

Inhibace

5 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

0,5 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

1 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

2,5 mg

Pilloli miksija b’rita

Użu orali

L-Irlanda

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

5 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| L-Italja |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

L-Italja

Inibace

1 mg

Pilloli miksija b’rita

Użu orali

L-Italja

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| L-Italja |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

L-Italja

Inibace

5 mg

Pilloli miksija b’rita

Użu orali

Il-Lussemburgu

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Il-Belġju |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Il-Belġju

Inhibace

0,5 mg

Pilloli miksija b’rita

Użu orali

Il-Lussemburgu

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Il-Belġju |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Il-Belġju

Inhibace

5 mg

Pilloli miksija b’rita

Użu orali

L-Olanda

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| L-Olanda |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

L-Olanda

Vascase 0,5

0,5 mg

Pilloli miksija b’rita

Użu orali

L-Olanda

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| L-Olanda |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

L-Olanda

Vascase 2,5

2,5 mg

Pilloli miksija b’rita

Użu orali

L-Olanda

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| L-Olanda |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

L-Olanda

Vascase 5

5 mg

Pilloli miksija b’rita

Użu orali

Il-Polonja

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Il-Polonja |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Il-Polonja

Inhibace

0,5 mg

Pilloli miksija b’rita

Użu orali

Il-Polonja

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Il-Polonja |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Il-Polonja

Inhibace

1 mg

Pilloli miksija b’rita

Użu orali

Il-Polonja

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Il-Polonja |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Il-Polonja

Inhibace

2,5 mg

Pilloli miksija b’rita

Użu orali

Il-Polonja

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Il-Polonja |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Il-Polonja

Inhibace

5 mg

Pilloli miksija b’rita

Użu orali

Il-Portugall

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Il-Portugall |

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 / Amadora

Il-Portugall

Inibace

1 mg

Pilloli miksija b’rita

Użu orali

Il-Portugall

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Il-Portugall |

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 / Amadora

Il-Portugall

Inibace

2,5 mg

Pilloli miksija b’rita

Użu orali

Il-Portugall

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada Nacional 249-1 |
| 2720-413 / Amadora |
| Il-Portugall |

Roche Farmacêutica Química, Lda.

Estrada Nacional 249-1

2720-413 / Amadora

Il-Portugall

Inibace

5 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spanja |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spanja

Inhibace

1 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spanja |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spanja

Inhibace

2,5 mg

Pilloli miksija b’rita

Użu orali

Spanja

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spanja |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spanja

Inhibace

5 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

0,5 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

1 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

2,5 mg

Pilloli miksija b’rita

Użu orali

Ir-Renju Unit

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| Welwyn Garden City / AL7 1TW |
| Ir-Renju Unit |

Roche Products Ltd

6 Falcon Way, Shire Park

Welwyn Garden City / AL7 1TW

Ir-Renju Unit

Vascace

5 mg

Pilloli miksija b’rita

Użu orali

---

ANNESS IX

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | id-Detentur ta’ l-Awtorizzzzjoni għat-tqegħid fis-suq | Isem ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | AstraZeneca Österreich GmbH., |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

Stat Membru UE/ŻEE

id-Detentur ta’ l-Awtorizzzzjoni għat-tqegħid fis-suq

Isem ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

L-Awstrija

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 2 mg - Tabletten

2 mg

Pillola

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 4 mg - Tabletten

4 mg

Pillola

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 8 mg - Tabletten

8 mg

Pillola

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 16 mg - Tabletten

16 mg

Pillola

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 32 mg - Tabletten

32 mg

Pillola

Użu orali

L-Awstrija

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 4 mg – Tabletten

4 mg

Pillola

Użu orali

L-Awstrija

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 8 mg – Tabletten

8 mg

Pillola

Użu orali

L-Awstrija

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 16 mg – Tabletten

16 mg

Pillola

Użu orali

L-Awstrija

| Takeda Pharma Ges.m.b.H. |
| --- |
| Seidengasse 33-35 |
| 1070 Wien |
| Austria |

Takeda Pharma Ges.m.b.H.

Seidengasse 33-35

1070 Wien

Austria

Blopress 32 mg – Tabletten

32 mg

Pillola

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

2 mg

Pillola

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

4 mg

Pillola

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

8 mg

Pillola

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

16 mg

Pillola

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

32 mg

Pillola

Użu orali

Il-Bulgarija

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

Il-Bulgarija

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

Il-Bulgarija

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Pillola

Użu orali

Ċipru

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

4 mg

Pillola

Użu orali

Ċipru

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

Ċipru

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

Ċipru

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Pillola

Użu orali

Ir-Repubblika Ċeka

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 4 mg

4 mg

Pillola

Użu orali

Ir-Repubblika Ċeka

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 8 mg

8 mg

Pillola

Użu orali

Ir-Repubblika Ċeka

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire United Kingdom

Atacand 16 mg

16 mg

Pillola

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

4 mg

Pillola

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

8 mg

Pillola

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

16 mg

Pillola

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

32 mg

Pillola

Użu orali

L-Estonja

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

L-Estonja

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

L-Estonja

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Pillola

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

2 mg

Pillola

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

4 mg

Pillola

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

8 mg

Pillola

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

16 mg

Pillola

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Il-Finlandja |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Il-Finlandja

Atacand

32 mg

Pillola

Użu orali

Franza

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 4 mg, comprimé sécable

4 mg

Pillola

Użu orali

Franza

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 8 mg, comprimé sécable

8 mg

Pillola

Użu orali

Franza

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 16 mg, comprimé sécable

16 mg

Pillola

Użu orali

Franza

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 Rueil- |
| Malmaison Cedex |
| France |

AstraZeneca

1, Place Renault

92844 Rueil-

Malmaison Cedex

France

Atacand 32 mg, comprimé sécable

32 mg

Pillola

Użu orali

Franza

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 4 mg, comprimé sécable

4 mg

Pillola

Użu orali

Franza

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 8 mg, comprimé sécable

8 mg

Pillola

Użu orali

Franza

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 16 mg, comprimé sécable

16 mg

Pillola

Użu orali

Franza

| Laboratoires Takeda |
| --- |
| 11-15, quai de Dion Bouton |
| 92816 Puteaux Cedex |
| France |

Laboratoires Takeda

11-15, quai de Dion Bouton

92816 Puteaux Cedex

France

Kenzen 32 mg, comprimé sécable

32 mg

Pillola

Użu orali

Il-Ġermanja

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 4 mg

4 mg

Pillola

Użu orali

Il-Ġermanja

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 8 mg

8 mg

Pillola

Użu orali

Il-Ġermanja

| AstraZeneca GmbH |
| --- |
| 22876 Wedel,Germany |

AstraZeneca GmbH

22876 Wedel,Germany

Atacand 16 mg

16 mg

Pillola

Użu orali

Il-Ġermanja

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand PROTECT 32 mg Tabletten

32 mg

Pillola

Użu orali

Il-Ġermanja

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 2 mg Tabletten

2 mg

Pillola

Użu orali

Il-Ġermanja

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 4 mg Tabletten

4 mg

Pillola

Użu orali

Il-Ġermanja

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 8 mg Tabletten

8 mg

Pillola

Użu orali

Il-Ġermanja

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 16 mg Tabletten

16 mg

Pillola

Użu orali

Il-Ġermanja

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 32 mg Tabletten

32 mg

Pillola

Użu orali

Il-Greċja

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astrnafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astrnafton

151 25 Maroussi

Greece

Atacand

2 mg

Pillola

Użu orali

Il-Greċja

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

4 mg

Pillola

Użu orali

Il-Greċja

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

8 mg

Pillola

Użu orali

Il-Greċja

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

16 mg

Pillola

Użu orali

Il-Greċja

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

32 mg

Pillola

Użu orali

L-Ungerija

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest,

Bocskai út 134-146

Hungary

Atacand

8 mg

Pillola

Użu orali

L-Ungerija

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest,

Bocskai út 134-146

Hungary

Atacand

16 mg

Pillola

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

4 mg

Pillola

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

8 mg

Pillola

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

16 mg

Pillola

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

32 mg

Pillola

Użu orali

L-Irlanda

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

2 mg

Pillola

Użu orali

L-Irlanda

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

4 mg

Pillola

Użu orali

L-Irlanda

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

8 mg

Pillola

Użu orali

L-Irlanda

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

16 mg

Pillola

Użu orali

L-Irlanda

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

32 mg

Pillola

Użu orali

L-Irlanda

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 2 mg

2 mg

Pillola

Użu orali

L-Irlanda

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OH

United Kingdom

Blopress 4 mg

4 mg

Pillola

Użu orali

L-Irlanda

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 8 mg

8 mg

Pillola

Użu orali

L-Irlanda

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 16 mg

16 mg

Pillola

Użu orali

L-Irlanda

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Blopress 32 mg

32 mg

Pillola

Użu orali

L-Italja

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) Italy

Ratacand

2 mg

Pillola

Użu orali

L-Italja

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) Italy

Ratacand

4 mg

Pillola

Użu orali

L-Italja

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) Italy

Ratacand

8 mg

Pillola

Użu orali

L-Italja

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) Italy

Ratacand

16 mg

Pillola

Użu orali

L-Italja

| AstraZeneca SpA |
| --- |
| Palazzo Volta, via F.Sforza – 20080 |
| Basiglio (MI) Italy |

AstraZeneca SpA

Palazzo Volta, via F.Sforza – 20080

Basiglio (MI) Italy

Ratacand

32 mg

Pillola

Użu orali

L-Italja

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 2 mg

2 mg

Pillola

Użu orali

L-Italja

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 4 mg

4 mg

Pillola

Użu orali

L-Italja

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 8 mg

8 mg

Pillola

Użu orali

L-Italja

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 16 mg

16 mg

Pillola

Użu orali

L-Italja

| Takeda Italia Farmaceutici S.p.A. |
| --- |
| Via Elio Vittorini, 129 |
| 00144 Roma |
| Italy |

Takeda Italia Farmaceutici S.p.A.

Via Elio Vittorini, 129

00144 Roma

Italy

Blopress 32 mg

32 mg

Pillola

Użu orali

Il-Latvja

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

Il-Latvja

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

Il-Litwanja

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

4 mg

Pillola

Użu orali

Il-Litwanja

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

Il-Litwanja

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

Il-Litwanja

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

32 mg

Pillola

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

2 mg

Pillola

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

4 mg

Pillola

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

8 mg

Pillola

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

16 mg

Pillola

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussels |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussels

Belgium

Atacand

32 mg

Pillola

Użu orali

Malta

| AstraZeneca AB, Gärtunavägen, |
| --- |
| S-15185, Södertälje, Sweden |

AstraZeneca AB, Gärtunavägen,

S-15185, Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

Malta

| AstraZeneca AB, Gärtunavägen, |
| --- |
| S-15185, Södertälje, Sweden |

AstraZeneca AB, Gärtunavägen,

S-15185, Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 2, tabletten 2 mg

2 mg

Pillola

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 4, tabletten 4 mg

4 mg

Pillola

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 8, tabletten 8 mg

8 mg

Pillola

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 16, tabletten 16 mg

16 mg

Pillola

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Atacand 32, tabletten 32 mg

32 mg

Pillola

Użu orali

In-Norveġja

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

4 mg

Pillola

Użu orali

In-Norveġja

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

8 mg

Pillola

Użu orali

In-Norveġja

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

16 mg

Pillola

Użu orali

In-Norveġja

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

32 mg

Pillola

Użu orali

Il-Polonja

| AstraZeneca AB, S-151 85, Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85, Södertälje

Gärtunavägen Sweden

Atacand

4 mg

Pillola

Użu orali

Il-Polonja

| AstraZeneca AB, S-151 85, Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85, Södertälje

Gärtunavägen Sweden

Atacand

8 mg

Pillola

Użu orali

Il-Polonja

| AstraZeneca AB, S-151 85, Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85, Södertälje

Gärtunavägen Sweden

Atacand

16 mg

Pillola

Użu orali

Il-Polonja

| AstraZeneca AB, S-151 85, Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85, Södertälje

Gärtunavägen Sweden

Atacand

32 mg

Pillola

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

2 mg

Pillola

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

4 mg

Pillola

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

8 mg

Pillola

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand

16 mg

Pillola

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7, |
| Valejas 2745-663 Barcarena, Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7,

Valejas 2745-663 Barcarena, Portugal

Atacand 32 mg

32 mg

Pillola

Użu orali

Il-Portugall

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

2 mg

Pillola

Użu orali

Il-Portugall

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

4 mg

Pillola

Użu orali

Il-Portugall

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

8 mg

Pillola

Użu orali

Il-Portugall

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

16 mg

Pillola

Użu orali

Il-Portugall

| Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A. |
| --- |
| Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo |
| 2730-055 Barcarena |
| Portugal |

Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.

Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo

2730-055 Barcarena

Portugal

Blopress

32 mg

Pillola

Użu orali

Ir-Rumanija

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 8 mg

8 mg

Pillola

Użu orali

Ir-Rumanija

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 16 mg

16 mg

Pillola

Użu orali

Ir-Rumanija

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 32 mg

32 mg

Pillola

Użu orali

Is-Slovakkja

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 8 mg

8 mg

Pillola

Użu orali

Is-Slovakkja

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 16 mg

16 mg

Pillola

Użu orali

Is-Slovakkja

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 32 mg

32 mg

Pillola

Użu orali

Is-Slovenja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 4 mg

4 mg

Pillola

Użu orali

Is-Slovenja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 8 mg

8 mg

Pillola

Użu orali

Is-Slovenja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 16 mg

16 mg

Pillola

Użu orali

Is-Slovenja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London W1K 1LN |
| United Kingdom |

AstraZeneca UK Limited

15 Stanhope Gate

London W1K 1LN

United Kingdom

Atacand 32 mg

32 mg

Pillola

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 4 mg comprimidos

4 mg

Pillola

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 8 mg comprimidos

8 mg

Pillola

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 16 mg comprimidos

16 mg

Pillola

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| Parque Norte.Edificio Roble. |
| C/ Serrano Galvache 56 |
| 28033 Madrid, Spain |

AstraZeneca Farmacéutica Spain, S.A.

Parque Norte.Edificio Roble.

C/ Serrano Galvache 56

28033 Madrid, Spain

Atacand 32 mg comprimidos

32 mg

Pillola

Użu orali

Spanja

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 4 mg comprimidos

4 mg

Pillola

Użu orali

Spanja

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 8 mg comprimidos

8 mg

Pillola

Użu orali

Spanja

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 16 mg comprimidos

16 mg

Pillola

Użu orali

Spanja

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 32 mg comprimidos

32 mg

Pillola

Użu orali

Spanja

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 4 mg comprimidos

4 mg

Pillola

Użu orali

Spanja

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 8 mg comprimidos

8 mg

Pillola

Użu orali

Spanja

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 16 mg comprimidos

16 mg

Pillola

Użu orali

Spanja

| Almirall, S.A. Ronda General Mitre, 151 |
| --- |
| 08022 Barcelona |
| Spain |

Almirall, S.A. Ronda General Mitre, 151

08022 Barcelona

Spain

Parapres 32 mg comprimidos

32 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

2 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

4 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

8 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

16 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

32 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

4 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

8 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

16 mg

Pillola

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

32 mg

Pillola

Użu orali

Ir-Renju Unit

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

2 mg

Pillola

Użu orali

Ir-Renju Unit

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

4 mg

Pillola

Użu orali

Ir-Renju Unit

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

8 mg

Pillola

Użu orali

Ir-Renju Unit

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

16 mg

Pillola

Użu orali

Ir-Renju Unit

| AstraZeneca UK Limited, |
| --- |
| 600 Capability Green, Luton, |
| LU1 3LU, United Kingdom |

AstraZeneca UK Limited,

600 Capability Green, Luton,

LU1 3LU, United Kingdom

Atacand

32 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 2 mg

2 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 4 mg

4 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 8 mg

8 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 16 mg

16 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda Global Research and Development Centre (Europe) Ltd |
| --- |
| 61 Aldwych |
| London |
| WC2B 4AE |
| United Kingdom |

Takeda Global Research and Development Centre (Europe) Ltd

61 Aldwych

London

WC2B 4AE

United Kingdom

Blopress 32 mg

32 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 2 mg

2 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 4 mg

4 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 8 mg

8 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 16 mg

16 mg

Pillola

Użu orali

Ir-Renju Unit

| Takeda UK Limited |
| --- |
| Takeda House, Mercury Park, |
| Wycombe Lane, Wooburn Green, |
| High Wycombe, |
| Buckinghamshire |
| HP10 OHH |
| United Kingdom |

Takeda UK Limited

Takeda House, Mercury Park,

Wycombe Lane, Wooburn Green,

High Wycombe,

Buckinghamshire

HP10 OHH

United Kingdom

Amias 32 mg

32 mg

Pillola

Użu orali

---

ANNESS X

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTT(I) MEDIĊINALI,MNEJN JINGĦATAW, L-APPLIKANT(I)/ID-DETENTUR(I) TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem inventat
  Isem | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| Awstrija | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Stat Membru UE/ŻEE

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem inventat

Isem

Qawwa

Għamla farmaċewtika

Mnejn jingħata

Awstrija

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 10 mg - Filmtabletten

10 mg

Pillola miksija b’rita

Użu orali

Awstrija

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 20 mg - Filmtabletten

20 mg

Pillola miksija b’rita

Użu orali

Awstrija

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 40 mg - Filmtabletten

40 mg

Pillola miksija b’rita

Użu orali

Awstrija

| Pfizer Corporation Austria Ges.m.b.H. |
| --- |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 80 mg - Filmtabletten

80 mg

Pillola miksija b’rita

Użu orali

Belġju

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Belġju

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Belġju

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Belġju

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels, Belgium

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Bulgarija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Bulgarija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Bulgarija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Bulgarija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Ċipru

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Ċipru

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Ċipru

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Repubblika Ċeka

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Repubblika Ċeka

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Repubblika Ċeka

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Repubblika Ċeka

| Pfizer, spol. s r.o., |
| --- |
| Stroupežnického 17, 150 00 Prague 5, |
| Czech Republic |

Pfizer, spol. s r.o.,

Stroupežnického 17, 150 00 Prague 5,

Czech Republic

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Danimarka

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

10 mg

Pillola miksija b’rita

Użu orali

Danimarka

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

20 mg

Pillola miksija b’rita

Użu orali

Danimarka

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

40 mg

Pillola miksija b’rita

Użu orali

Danimarka

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

80 mg

Pillola miksija b’rita

Użu orali

Estonja

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Estonja

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Estonja

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Estonja

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis 80 mg

80 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

10 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

20 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

40 mg

Pillola miksija b’rita

Użu orali

Finlandja

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

80 mg

Pillola miksija b’rita

Użu orali

Franza

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

10 mg

Pillola miksija b’rita

Użu orali

Franza

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

20 mg

Pillola miksija b’rita

Użu orali

Franza

| Pfizer Holding France |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding France

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

40 mg

Pillola miksija b’rita

Użu orali

Franza

| Pfizer Holding Franza |
| --- |
| 23-25 Avenue du Docteur Lannelongue |
| 75668 Paris Cedex 14 |
| France |

Pfizer Holding Franza

23-25 Avenue du Docteur Lannelongue

75668 Paris Cedex 14

France

Tahor

80 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 10 mg

10 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 20 mg

20 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 40 mg

40 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 80 mg

80 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 10 mg

10 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 20 mg

20 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 40 mg

40 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 80 mg

80 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 10 mg PD

10 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 20 mg PD

20 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 40 mg PD

40 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 80 mg PD

80 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Greċja

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou |
| Street |
| 115 28 Ilisia |
| Athens, Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou

Street

115 28 Ilisia

Athens, Greece

Zarator

10 mg

Pillola miksija b’rita

Użu orali

Greċja

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou |
| Street |
| 115 28 Ilisia |
| Athens, Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou

Street

115 28 Ilisia

Athens, Greece

Zarator

20 mg

Pillola miksija b’rita

Użu orali

Greċja

| WIN MEDICA Ltd |
| --- |
| 41 Papadiamantopoulou |
| Street |
| 115 28 Ilisia |
| Athens, Greece |

WIN MEDICA Ltd

41 Papadiamantopoulou

Street

115 28 Ilisia

Athens, Greece

Zarator

40 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Edovin

10 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Edovin

20 mg

Pillola miksija b’rita

Użu orali

Greċja

| Pfizer Hellas A. E. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, Greece |

Pfizer Hellas A. E.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens, Greece

Edovin

40 mg

Pillola miksija b’rita

Użu orali

Ungerija

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park “F” Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park “F” Ép.,

Hungary

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Ungerija

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park “F” Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park “F” Ép.,

Hungary

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Ungerija

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park “F” Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park “F” Ép.,

Hungary

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Ungerija

| Pfizer KFT, |
| --- |
| 1123 Budapest, |
| Alkotás u. 53. MOM Park “F” Ép., |
| Hungary |

Pfizer KFT,

1123 Budapest,

Alkotás u. 53. MOM Park “F” Ép.,

Hungary

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Ungerija

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

10 mg

Pillola miksija b’rita

Użu orali

Ungerija

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

20 mg

Pillola miksija b’rita

Użu orali

Ungerija

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

40 mg

Pillola miksija b’rita

Użu orali

Ungerija

| C.P. Pharma Gyógyszerkereskedelmi Kft. |
| --- |
| 2040 Budaörs |
| Vasút u. 11. |
| Hungary |

C.P. Pharma Gyógyszerkereskedelmi Kft.

2040 Budaörs

Vasút u. 11.

Hungary

Obradon

80 mg

Pillola miksija b’rita

Użu orali

Iżlanda

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

10 mg

Pillola miksija b’rita

Użu orali

Iżlanda

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

20 mg

Pillola miksija b’rita

Użu orali

Iżlanda

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

40 mg

Pillola miksija b’rita

Użu orali

Iżlanda

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

80 mg

Pillola miksija b’rita

Użu orali

Irlanda

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Irlanda

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Irlanda

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Irlanda

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Xarator

10 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. Via Isonzo, 71 |
| --- |
| 04100 Latina - Italy |

Pfizer Italia S.r.l. Via Isonzo, 71

04100 Latina - Italy

Xarator

20 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Xarator

40 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Xarator

80 mg

Pillola miksija b’rita

Użu orali

Italja

| Bioindustria Farmaceutici S.r.l |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Bioindustria Farmaceutici S.r.l

Via Isonzo, 71

04100 Latina - Italy

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Italja

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Italja

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Italja

| Bioindustria Farmaceutici S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Bioindustria Farmaceutici S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Torvast

10 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Torvast

20 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Torvast

40 mg

Pillola miksija b’rita

Użu orali

Italja

| Pfizer Italia S.r.l. |
| --- |
| Via Isonzo, 71 |
| 04100 Latina - Italy |

Pfizer Italia S.r.l.

Via Isonzo, 71

04100 Latina - Italy

Torvast

80 mg

Pillola miksija b’rita

Użu orali

Italja

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa - Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa - Italy

Totalip

10 mg

Pillola miksija b’rita

Użu orali

Italja

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa - Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa - Italy

Totalip

20 mg

Pillola miksija b’rita

Użu orali

Italja

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa - Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa - Italy

Totalip

40 mg

Pillola miksija b’rita

Użu orali

Italja

| Laboratori Guidotti S.p.A. |
| --- |
| Via Livornese, 897 - La Vettola |
| 56010 Pisa - Italy |

Laboratori Guidotti S.p.A.

Via Livornese, 897 - La Vettola

56010 Pisa - Italy

Totalip

80 mg

Pillola miksija b’rita

Użu orali

Latvja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Latvja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Latvja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Latvja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent CT 13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT 13 9NJ, United Kingdom

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Litwanja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Litwanja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Litwanja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Litwanja

| Pfizer Limited, |
| --- |
| Ramsgate Road, |
| Sandwich, Kent, CT13 9NJ, United Kingdom |

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Lussemburgu

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Lussemburgu

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Lussemburgu

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Lussemburgu

| Pfizer SA |
| --- |
| Boulevard de la Plaine 17 |
| B-1050 Brussels, |
| Belgium |

Pfizer SA

Boulevard de la Plaine 17

B-1050 Brussels,

Belgium

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Malta

| Pfizer Hellas S.A. |
| --- |
| 243, Messoghion Ave., |
| 154 51 Νeo Psychiko, Athens, |
| Greece |

Pfizer Hellas S.A.

243, Messoghion Ave.,

154 51 Νeo Psychiko, Athens,

Greece

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Olanda

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Olanda

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Olanda

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Olanda

| Pfizer bv |
| --- |
| Rivium Westlaan 142 |
| 2909 LD Capelle a/d IJssel |
| The Netherlands |

Pfizer bv

Rivium Westlaan 142

2909 LD Capelle a/d IJssel

The Netherlands

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Norveġja

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Norveġja

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Norveġja

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Norveġja

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Polonja

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 10

10 mg

Pillola miksija b’rita

Użu orali

Polonja

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 20

20 mg

Pillola miksija b’rita

Użu orali

Polonja

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 40

40 mg

Pillola miksija b’rita

Użu orali

Polonja

| Pfizer Polska Sp.z o.o. |
| --- |
| ul. Rzymowskiego 28 |
| 02-697 Warszawa |
| Polond |

Pfizer Polska Sp.z o.o.

ul. Rzymowskiego 28

02-697 Warszawa

Polond

Sortis 80

80 mg

Pillola miksija b’rita

Użu orali

Portugall

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

10 mg

Pillola miksija b’rita

Użu orali

Portugall

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

20 mg

Pillola miksija b’rita

Użu orali

Portugall

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

40 mg

Pillola miksija b’rita

Użu orali

Portugall

| Laboratorios Pfizer, Lda., |
| --- |
| Lagoas Park, Edifício 10, |
| 2740-271 Porto Salvo, Portugal |

Laboratorios Pfizer, Lda.,

Lagoas Park, Edifício 10,

2740-271 Porto Salvo, Portugal

Zarator

80 mg

Pillola miksija b’rita

Użu orali

Portugall

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

10 mg

Pillola miksija b’rita

Użu orali

Portugall

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

20 mg

Pillola miksija b’rita

Użu orali

Portugall

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

40 mg

Pillola miksija b’rita

Użu orali

Portugall

| Parke-Davis - Produtos Farmaceuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Parke-Davis - Produtos Farmaceuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Atorvastatina Parke-Davis

80 mg

Pillola miksija b’rita

Użu orali

Portugall

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

10 mg

Pillola miksija b’rita

Użu orali

Portugall

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

20 mg

Pillola miksija b’rita

Użu orali

Portugall

| Farmogene - Produtos Farmacêuticos, Lda, |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

40 mg

Pillola miksija b’rita

Użu orali

Portugall

| Farmogene - Produtos Farmacêuticos, Lda., |
| --- |
| Lagoas Park, Edifício 10, 2740-271 Porto Salvo, |
| Portugal |

Farmogene - Produtos Farmacêuticos, Lda.,

Lagoas Park, Edifício 10, 2740-271 Porto Salvo,

Portugal

Texzor

80 mg

Pillola miksija b’rita

Użu orali

Rumanija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Rumanija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Rumanija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Rumanija

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Repubblika Slovakka

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

10 mg

Pillola miksija b’rita

Użu orali

Repubblika Slovakka

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

20 mg

Pillola miksija b’rita

Użu orali

Repubblika Slovakka

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

40 mg

Pillola miksija b’rita

Użu orali

Repubblika Slovakka

| Pfizer Europe MA EEIG, Ramsgate Road, |
| --- |
| Sandwich, |
| Kent, CT13 9NJ, |
| United Kingdom |

Pfizer Europe MA EEIG, Ramsgate Road,

Sandwich,

Kent, CT13 9NJ,

United Kingdom

Sortis

80 mg

Pillola miksija b’rita

Użu orali

Slovenja

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 10 mg filmsko obložene tablete

10 mg

Pillola miksija b’rita

Użu orali

Slovenja

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 20 mg filmsko obložene tablete

20 mg

Pillola miksija b’rita

Użu orali

Slovenja

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 40 mg filmsko obložene tablete

40 mg

Pillola miksija b’rita

Użu orali

Slovenja

| Pfizer Luxembourg SARL, |
| --- |
| 51, Avenue J. F. Kennedy, L-1855 Luxembourg, |
| Luxembourg |

Pfizer Luxembourg SARL,

51, Avenue J. F. Kennedy, L-1855 Luxembourg,

Luxembourg

Sortis 80 mg filmsko obložene tablete

80 mg

Pillola miksija b’rita

Użu orali

Spanja

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

10 mg

Pillola miksija b’rita

Użu orali

Spanja

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

20 mg

Pillola miksija b’rita

Użu orali

Spanja

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

40 mg

Pillola miksija b’rita

Użu orali

Spanja

| Parke Davis. S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Parke Davis. S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Zarator

80 mg

Pillola miksija b’rita

Użu orali

Spanja

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

10 mg

Pillola miksija b’rita

Użu orali

Spanja

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

20 mg

Pillola miksija b’rita

Użu orali

Spanja

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

40 mg

Pillola miksija b’rita

Użu orali

Spanja

| Pfizer, S.A. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Pfizer, S.A.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Cardyl

80 mg

Pillola miksija b’rita

Użu orali

Spanja

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

10 mg

Pillola miksija b’rita

Użu orali

Spanja

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

20 mg

Pillola miksija b’rita

Użu orali

Spanja

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

40 mg

Pillola miksija b’rita

Użu orali

Spanja

| Nostrum Farma, S.A., Avda. de Europa 20B |
| --- |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

Nostrum Farma, S.A., Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Nostrum

80 mg

Pillola miksija b’rita

Użu orali

Spanja

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

10 mg

Pillola miksija b’rita

Użu orali

Spanja

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

20 mg

Pillola miksija b’rita

Użu orali

Spanja

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

40 mg

Pillola miksija b’rita

Użu orali

Spanja

| PHARMACIA GRUPO PFIZER, S.L. |
| --- |
| Avda. de Europa 20B |
| Parque Empresarial la Moraleja |
| 28108 Alcobendas, (Madrid) |
| Spain |

PHARMACIA GRUPO PFIZER, S.L.

Avda. de Europa 20B

Parque Empresarial la Moraleja

28108 Alcobendas, (Madrid)

Spain

Atorvastatina Pharmacia

80 mg

Pillola miksija b’rita

Użu orali

Spanja

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

10 mg

Pillola miksija b’rita

Użu orali

Spanja

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

20 mg

Pillola miksija b’rita

Użu orali

Spanja

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

40 mg

Pillola miksija b’rita

Użu orali

Spanja

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

80 mg

Pillola miksija b’rita

Użu orali

Żvezja

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Żvezja

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Żvezja

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Żvezja

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

Renju Unit

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Pillola miksija b’rita

Użu orali

Renju Unit

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Pillola miksija b’rita

Użu orali

Renju Unit

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Pillola miksija b’rita

Użu orali

Renju Unit

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin Ireland

Lipitor

80 mg

Pillola miksija b’rita

Użu orali

---

ANNESS XI

KONKLUŻJONIJIET XJENTIFIĊI U RAĠUNIJIET GĦALL-EMENDA TAS-SOMMARJU TAL-KARATTERISTIĊI TAL-PRODOTT U L-FULJETT TA’ TAGĦRIF

Il-prodotti mediċinali veterinarji kollha għall-ispeċi li jipproduċu l-ikel u li fihom il-kwinoloni u/jew il-florokwinoloni bħala sustanzi attivi.

---

ANNESS XII

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta’ l-Awrorizzazzjoni għat-tqegħid fis-suq | Isem ivvintat | Qawwa | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | AstraZeneca Österreich GmbH |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

Stat Membru

Id-Detentur ta’ l-Awrorizzazzjoni għat-tqegħid fis-suq

Isem ivvintat

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

L-Awstrija

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 50 mg – Retardtabletten

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 150 mg – Retardtabletten

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austra |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austra

Seroquel XR 200 mg – Retardtabletten

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 300 mg – Retardtabletten

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Awstrija

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Austria |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Austria

Seroquel XR 400 mg – Retardtabletten

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 150 mg prolonged-release tablets

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 400 mg prolonged-release tablets

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Ċipru

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| Ir-Renju Unit |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

Ir-Renju Unit

Seroquel XR 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Ċipru

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Ċipru

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Ċipru

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| United Kingdom |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

United Kingdom

Seroquel XR 400 mg prolonged-release tablets

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 50 mg Retardtabletten

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 150 mg Retardtabletten

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 200 mg Retardtabletten

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 300 mg Retardtabletten

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Ġermanja

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Germany |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Germany

Seroquel Prolong 400 mg Retardtabletten

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 150 mg prolonged-release tablets

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong 400 mg prolonged-release tablets

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 50 mg

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 150 mg

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 200 mg

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 300 mg

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Greċja

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Greece |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Greece

Seroquel XR 400 mg

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 50 mg comprimidos de liberación prolongada

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 150 mg comprimidos de liberación prolongada

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 200 mg comprimidos de liberación prolongada

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 300 mg comprimidos de liberación prolongada

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spain |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spain

Seroquel Prolong 400 mg comprimidos de liberación prolongada

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 50 mg depottabletti

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 150 mg depottabletti

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 200 mg depottabletti

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 300 mg depottabletti

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 400 mg depottabletti

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Islanda

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United kingdom

Seroquel XR 150 mg prolonged-release tablets

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Irlanda

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| United Kingdom |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

United Kingdom

Seroquel XR 400 mg prolonged-release tablets

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 150 mg prolonged-release tablets

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgium

Seroquel XR 400 mg prolonged-release tablets

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 150 mg prolonged-release tablets

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| United Kingdom |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

United Kingdom

Seroquel XR 400 mg prolonged-release tablets

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 50 mg prolonged-release tablets

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 150 mg prolonged-release tablets

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 200 mg prolonged-release tablets

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 300 mg prolonged-release tablets

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| The Netherlands |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

The Netherlands

Seroquel XR 400 mg prolonged-release tablets

400 mg

Prolonged-release tablet

Użu orali

In-Norveġja

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 50 mg depottabletter

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

In-Norveġja

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 150 mg depottabletter

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

In-Norveġja

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 200 mg depottabletter

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

In-Norveġja

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 300 mg depotabletter

300 mg

Prolonged-release tablet

Użu orali

In-Norveġja

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norway |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norway

Seroquel Depot 400 mg depottabletter

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Polonja

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, UK |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, UK

Seroquel XR

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, 7 |
| Valejas |
| 2745-663 Barcarena |
| Portugal |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, 7

Valejas

2745-663 Barcarena

Portugal

Seroquel SR

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 50 mg depottabletter

50 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 150 mg depottabletter

150 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 200 mg depottabletter

200 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 300 mg depottabletter

300 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

L-Isvezja

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sweden |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sweden

Seroquel Depot 400 mg depottabletter

400 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

---

ANNESS XIII

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT, MNEJN JINGĦATA, DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTAT MEMBRU

| Stat Membru/EEA | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem kummerċjali | Għamla Farmaċewtika | Qawwa | Speċi li fuqhom għandu jintuża l-prodott | Mod ta’ Amministrazzjoni |
| --- | --- | --- | --- | --- | --- | --- |
| Awstrija | Novartis Animal Health GmbH., |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Stat Membru/EEA

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem kummerċjali

Għamla Farmaċewtika

Qawwa

Speċi li fuqhom għandu jintuża l-prodott

Mod ta’ Amministrazzjoni

Awstrija

Novartis Animal Health GmbH.,

Biochemiestrasse 10,

6250 Kundl

AUSTRIA

Denagard Novartis 100 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Premix

100 g/kg

Majjali

Orali

Awstrija

| Novartis Animal Health GmbH., |
| --- |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Novartis Animal Health GmbH.,

Biochemiestrasse 10,

6250 Kundl

AUSTRIA

Denagard Novartis 20 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Premix

20 g/kg

Majjali

Orali

Awstrija

| Novartis Animal Health GmbH., |
| --- |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Novartis Animal Health GmbH.,

Biochemiestrasse 10,

6250 Kundl

AUSTRIA

Tiamutin 20 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine

Premix

20 g/kg

Majjali

Orali

Belġju

| VMD nv |
| --- |
| Leo Aerden |
| Hoge Mauw 900, |
| 2370 Arendonk |
| BELGIUM |

VMD nv

Leo Aerden

Hoge Mauw 900,

2370 Arendonk

BELGIUM

Tiamutin 10 % gemedicineerd voormengsel

Premix

100 mg/g

Majjali

Orali

Ċipru

| Novartis Animal Health Inc., |
| --- |
| Basle, |
| SWITZERLAND. |

Novartis Animal Health Inc.,

Basle,

SWITZERLAND.

Denagard 10 %

Premix

100 mg/g

Majjali

Orali

Repubblika Ċeka

| Novartis Animal Health d.o.o., Verovškova 57, |
| --- |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o., Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % premix ad us.vet.

Premix

100 mg/g

Majjali

Tiġieġ

Dundjani

Orali

Repubblika Ċeka

| Novartis Animal Health d.o.o., Verovškova 57, |
| --- |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o., Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 2 % premix ad us.vet.

Premix

20 mg/g

Majjali

Tiġieġ

Dundjani

Orali

Franza

| Novartis Sante Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Sante Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Denagard prémélange tiamuline 16,2 pneumonie volaille - porc

Premix

16,2 mg/g

Majjali

Dundjani

Tiġieġ

Orali

Franza

| Novartis Sante Animale |
| --- |
| 14 Boulevard Richelieu |
| 92500 Rueil Malmaison |
| FRANCE |

Novartis Sante Animale

14 Boulevard Richelieu

92500 Rueil Malmaison

FRANCE

Denagard prémélange tiamuline 6,5 enterite porc enterocolite lapin

Premix

6,5 mg/g

Fniek

Majjali

Orali

Ġermanja

| Novartis Tiergesundheit GmbH |
| --- |
| Zielstattstr. 40, |
| 81379 München |
| GERMANY |

Novartis Tiergesundheit GmbH

Zielstattstr. 40,

81379 München

GERMANY

Denagard 10 % AMV

Premix

100 g/kg

Majjali

Orali

Greċja

| Premier Shukuroglou Hellas S.A |
| --- |
| Mesogion Av 198, |
| 15561 Holargos |
| GREECE |

Premier Shukuroglou Hellas S.A

Mesogion Av 198,

15561 Holargos

GREECE

Denagard 2 %

Premix

20 mg/g

Majjali

Orali

Greċja

| Premier Shukuroglou Hellas S.A |
| --- |
| Mesogion Av 198, |
| 15561 Holargos |
| GREECE |

Premier Shukuroglou Hellas S.A

Mesogion Av 198,

15561 Holargos

GREECE

Denagard 10 %

Premix

100 mg/g

Majjali

Orali

Ungerija

| Novartis Animal Health d.o.o. |
| --- |
| Verovskova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovskova 57,

1000 Ljubljana

SLOVENIA

Denagard 10 % gyógypremix A.U.V.

Premix

100 mg/g

Majjali

Orali

Irlanda

| Novartis Animal Health Ireland Ltd., |
| --- |
| Industrial Park, |
| Cork Road, |
| Waterford |
| IRELAND |

Novartis Animal Health Ireland Ltd.,

Industrial Park,

Cork Road,

Waterford

IRELAND

Tiamutin 2 %

Premix

20 mg/g

Majjali

Orali

Irlanda

| Novartis Animal Health Ireland Ltd., |
| --- |
| Industrial Park, |
| Cork Road, |
| Waterford |
| IRELAND |

Novartis Animal Health Ireland Ltd.,

Industrial Park,

Cork Road,

Waterford

IRELAND

Tiamutin 80 %

Premix

800 mg/g

Majjali

Orali

Italja

| Novartis Animal Health S.P.A |
| --- |
| Largo Umberto Boccioni, 1 |
| 21040 Origlio (Varese) |
| ITALY |

Novartis Animal Health S.P.A

Largo Umberto Boccioni, 1

21040 Origlio (Varese)

ITALY

Denagard 10 % Premix

Premix

100 mg/g

Majjali

Tiġieġ

Orali

Italja

| Novartis Animal Health S.P.A |
| --- |
| Largo Umberto Boccioni, 1 |
| 21040 Origlio (Varese) |
| ITALY |

Novartis Animal Health S.P.A

Largo Umberto Boccioni, 1

21040 Origlio (Varese)

ITALY

Denagard 10 % Premix Plus

Premix

100 mg/g

Majjali

Orali

Latvja

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % premix

Premix

100 mg/g

Majjali

Orali

Litwanja

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % vaistinis premiksas kiaulėms

Premix

100 mg/g

Majjali

Orali

Portugall

| Novartis Farma Produtos Farmacêuticos S.A |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 |
| Quinta da Beloura |
| 2710-444 Sintra |
| PORTUGAL |

Novartis Farma Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edifício 8

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Denagard 20 g/Kg

Premix

20 g/kg

Majjali

Tiġieġ

Dundjani

Orali

Portugall

| Novartis Farma Produtos Farmacêuticos S.A |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 |
| Quinta da Beloura |
| 2710-444 Sintra |
| PORTUGAL |

Novartis Farma Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edifício 8

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Denagard 100 g/Kg

Premix

100 g/kg

Majjali

Tiġieġ

Dundjani

Fniek

Orali

Portugall

| Novartis Farma Produtos Farmacêuticos S.A |
| --- |
| Rua do Centro Empresarial |
| Edifício 8 |
| Quinta da Beloura |
| 2710-444 Sintra |
| PORTUGAL |

Novartis Farma Produtos Farmacêuticos S.A

Rua do Centro Empresarial

Edifício 8

Quinta da Beloura

2710-444 Sintra

PORTUGAL

Dynamutilin 100 g/Kg

Premix

100 g/kg

Majjali

Tiġieġ

Dundjani

Orali

Polonja

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % premiks leczniczy dla świń

Premix

100 mg/g

Majjali

Orali

Polonja

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 2 % 20 mg/g premiks do sporządzania paszy leczniczej dla świń

Premix

20 mg/g

Majjali

Orali

Rumanija

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % Premix pentru furaje medicamentate pentru porci

Premix

100 mg/g

Majjali

Tiġieġ

Dundjani

Orali

Rumanija

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| SI-1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

SI-1000 Ljubljana

SLOVENIA

Tiamutin 80 % coated

Premix

800 g/100 kg

Majjali

Tiġieġ

Dundjani

Orali

Slovakja

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 10 % prm. ad us. vet.

Premix

100 mg/g

Majjali

Tiġieġ

Dundjani

Orali

Slovakja

| Novartis Animal Health d.o.o. |
| --- |
| Verovškova 57, |
| 1000 Ljubljana |
| SLOVENIA |

Novartis Animal Health d.o.o.

Verovškova 57,

1000 Ljubljana

SLOVENIA

Tiamutin 2 % prm. ad us. vet.

Premix

20 mg/g

Majjali

Tiġieġ

Dundjani

Orali

Spanja

| Novartis Sanidad Animal, S.L. |
| --- |
| c/De la Marina, 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal, S.L.

c/De la Marina, 206

08013 Barcelona

SPAIN

Denagard 100 g/kg Premezcla medicamentosa

Premix

100 g/kg

Majjali

Tiġieġ

Dundjani

Fniek

Orali

Spanja

| Novartis Sanidad Animal, S.L. |
| --- |
| c/De la Marina, 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal, S.L.

c/De la Marina, 206

08013 Barcelona

SPAIN

Denagard 20 g/kg Premezcla medicamentosa

Premix

20 g/kg

Majjali

Fniek

Orali

Spanja

| Novartis Sanidad Animal, S.L. |
| --- |
| c/De la Marina, 206 |
| 08013 Barcelona |
| SPAIN |

Novartis Sanidad Animal, S.L.

c/De la Marina, 206

08013 Barcelona

SPAIN

Dynamutilin 10 %

Premix

100 g/kg

Majjali

Tiġieġ

Dundjani

Orali

Żvezja

| Novartis Healthcare A/S |
| --- |
| Animal Health |
| Lyngbyvej 172 |
| DK-2100 Köpenhamn Ö |
| DENMARK |

Novartis Healthcare A/S

Animal Health

Lyngbyvej 172

DK-2100 Köpenhamn Ö

DENMARK

Denagard vet.

Premix

20 mg/g

Majjali

Orali

Olanda

| Novartis Consumer health |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| The NETHERLANDS |

Novartis Consumer health

Claudius Prinsenlaan 142

4818 CP Breda

The NETHERLANDS

Tiamutin 10 %

Premix

100 g/kg

Majjali

Orali

Olanda

| Novartis Consumer health |
| --- |
| Claudius Prinsenlaan 142 |
| 4818 CP Breda |
| The NETHERLANDS |

Novartis Consumer health

Claudius Prinsenlaan 142

4818 CP Breda

The NETHERLANDS

Denagard 2 %

Premix

20 g/kg

Majjali

Orali

Renju Unit

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

Denagard 2 % w/w

Premix

2 mg/g

Majjali

Orali

Renju Unit

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

Denagard 80 % w/w

Premix

80 mg/g

Majjali

Orali

Renju Unit

| Novartis Animal Health UK Ltd |
| --- |
| Frimley Business Park |
| Frimley |
| Camberley |
| Surrey |
| GU16 7SR |
| United Kingdom |

Novartis Animal Health UK Ltd

Frimley Business Park

Frimley

Camberley

Surrey

GU16 7SR

United Kingdom

Denagard 10 % w/w

Premix

100 mg/g

Majjali

Orali

---

ANNESS XIV

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI/DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru (UE/ŻEE) | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Applikant | Isem (ivvintat) | Qawwa | Għamla farmaċewtika | Mnejn u kif jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| Il-Belġju | | IDL, 36 avenue Hoche, |
| 75008 Paris. FRANZA |

Stat Membru (UE/ŻEE)

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Applikant

Isem (ivvintat)

Qawwa

Għamla farmaċewtika

Mnejn u kif jingħata

Il-Belġju

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 25 mg

25 mg

kapsula

Użu orali

Il-Belġju

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 50 mg

50 mg

kapsula

Użu orali

Il-Belġju

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 100 mg

100 mg

kapsula

Użu orali

Il-Ġermanja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 25 mg

25 mg

kapsula

Użu orali

Il-Ġermanja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 50 mg

50 mg

kapsula

Użu orali

Il-Ġermanja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 100 mg

100 mg

kapsula

Użu orali

L-Italja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporina IDL 25 mg

25 mg

kapsula

Użu orali

L-Italja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporina IDL 50 mg

50 mg

kapsula

Użu orali

L-Italja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporina IDL 100 mg

100 mg

kapsula

Użu orali

Il-Pajjiżi l-Baxxi

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche

75008 Paris. FRANZA

Ciclosporin IDL 25 mg

25 mg

kapsula, ratba

Użu orali

Il-Pajjiżi l-Baxxi

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche

75008 Paris. FRANZA

Ciclosporin IDL 50 mg

50 mg

kapsula, ratba

Użu orali

Il-Pajjiżi l-Baxxi

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche

75008 Paris. FRANZA

Ciclosporin IDL 100 mg

100 mg

kapsula, ratba

Użu orali

Spanja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporina IDL 25 mg

25 mg

kapsula

Użu orali

Spanja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporina IDL 50 mg

50 mg

kapsula

Użu orali

Spanja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporina IDL 100 mg

100 mg

kapsula

Użu orali

L-Isvezja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciklosporin IDL 25 mg

25 mg

kapsula

Użu orali

L-Isvezja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciklosporin IDL 50 mg

50 mg

kapsula

Użu orali

L-Iżvezja

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciklosporin IDL 100 mg

100 mg

kapsula

Użu orali

Ir-Renju Unit

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 25 mg

25 mg

kapsula

Użu orali

Ir-Renju Unit

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 50 mg

50 mg

kapsula

Użu orali

Ir-Renju Unit

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANZA |

IDL, 36 avenue Hoche,

75008 Paris. FRANZA

Ciclosporin IDL 100 mg

100 mg

kapsula

Użu orali

---

ANNESS XV

LISTA TAL-ISMIJIET INVENTAT, GĦAMLA FARMAĊEWTIKA, QAWWIETTAL-PRODOTTI MEDIĊINALI,MNEJN JINGĦATA U ID-DETENTUR(I) TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI (EU/EEA)

| Stat Membru EU/EEA | Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq | Isem inventat | Qawwa | Għamla farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- |
| Awstrija | Abbott GmbH |
| Perfektastraße 84A |
| A-1230 Wien |
| Awstrija |

Stat Membru EU/EEA

Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq

Isem inventat

Qawwa

Għamla farmaċewtika

Mnejn jingħata

Awstrija

Abbott GmbH

Perfektastraße 84A

A-1230 Wien

Awstrija

Reductil 10 mg - Hartkapseln

10 mg

Kapsula, iebsa

Għal użu orali

Awstrija

| Abott GmbH |
| --- |
| Perfektastraße 84A |
| A-1230 Wien |
| Awstrija |

Abott GmbH

Perfektastraße 84A

A-1230 Wien

Awstrija

Reductil 15 mg - Hartkapseln

15 mg

Kapsula, iebsa

Għal użu orali

Awstrija

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Olanda

Sibutramin Teva 10 mg Kapseln

10 mg

Kapsula, iebsa

Għal użu orali

Awstrija

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Olanda

Sibutramin Teva 15 mg Kapseln

15 mg

Kapsula, iebsa

Għal użu orali

Belġjum

| Abbott SA |
| --- |
| rue du Bosquet 2 |
| 1348 Ottignies/LLN |
| Belġjum |

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belġjum

Reductil 10 mg

10 mg

Kapsula, iebsa

Għal użu orali

Belġjum

| Abbott SA |
| --- |
| rue du Bosquet 2 |
| 1348 Ottignies/LLN |
| Belġjum |

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belġjum

Reductil 15 mg

15 mg

Kapsula, iebsa

Għal użu orali

Belġjum

| Sandoz NV |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belġjum |

Sandoz NV

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belġjum

Sibutramin Sandoz 10 mg

10 mg

Kapsula, iebsa

Għal użu orali

Belġjum

| Sandoz NV |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belġjum |

Sandoz NV

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belġjum

Sibutramin Sandoz 15 mg

15 mg

Kapsula, iebsa

Għal użu orali

Belġjum

| Teva pharma belgium |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belġjum |

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belġjum

Sibutramin Teva 10 mg

10 mg

Kapsula, iebsa

Għal użu orali

Belġjum

| Teva pharma belgium |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belġjum |

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belġjum

Sibutramin Teva 15 mg

15 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Abbott GmbH & Co KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Abbott GmbH & Co KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| SI - 1000 Ljubljana |
| Slovenja |

Sandoz d.d.,

Verovskova 57

SI - 1000 Ljubljana

Slovenja

Sibutramin Sandoz

10 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI - 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovskova 57

SI - 1000 Ljubljana

Slovenja

Sibutramin Sandoz

15 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Republika Ċeka |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Republika Ċeka

Lindaxa

10 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Republika Ċeka |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Republika Ċeka

Lindaxa

15 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V. Gogol str. |
| Sredetz district |
| 1124 Sofia |
| Bulgarija |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgarija

Meissa

10 mg

Kapsula, iebsa

Għal użu orali

Bulgarija

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V. Gogol str. |
| Sredetz district |
| 1124 Sofia |
| Bulgarija |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgarija

Meissa

15 mg

Kapsula, iebsa

Għal użu orali

Republika Ċeka

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring-2 |
| 65202 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring-2

65202 Wiesbaden

Ġermanja

MERIDIA 10 MG

10 mg

Kapsula, iebsa

Għal użu orali

Republika Ċeka

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring-2 |
| 65202 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring-2

65202 Wiesbaden

Ġermanja

MERIDIA 15 MG

15 mg

Kapsula, iebsa

Għal użu orali

Republika Ċeka

| Zentiva, k.s. |
| --- |
| U kabelovny 130, 102 37 |
| Prague 10 |
| Republika Ċeka |

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Republika Ċeka

LINDAXA 10

10 mg

Kapsula, iebsa

Għal użu orali

Republika Ċeka

| Zentiva, k.s. |
| --- |
| U kabelovny 130, 102 37 |
| Prague 10 |
| Republika Ċeka |

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Republika Ċeka

LINDAXA 15

15 mg

Kapsula, iebsa

Għal użu orali

Republika Ċeka

| TEVA Pharmaceuticals ČR, s.r.o. |
| --- |
| Radlická 3185/Ic |
| 150 00 Prague 5 |
| Republika Ċeka |

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Republika Ċeka

SIBUTRAMIN-TEVA 10 MG TOBOLKY

10 mg

Kapsula, iebsa

Għal użu orali

Republika Ċeka

| TEVA Pharmaceuticals ČR, s.r.o. |
| --- |
| Radlická 3185/Ic |
| 150 00 Prague 5 |
| Republika Ċeka |

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Republika Ċeka

SIBUTRAMIN-TEVA 15 MG TOBOLKY

15 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| Abbott Scandinavia AB |
| --- |
| Postboks 509 |
| SE-169 29, Solna |
| Svezja |

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Svezja

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| Abbott Scandinavia AB |
| --- |
| Postboks 509 |
| SE-169 29, Solna |
| Svezja |

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Svezja

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| 1A Farma A/S |
| --- |
| Herstedøstervej 27-29 |
| DK-2620 Albertslund |
| Danimarka |

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Danimarka

Sibutramin “1A Farma”

10 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| 1A Farma A/S |
| --- |
| Herstedøstervej 27-29 |
| DK-2620 Albertslund |
| Danimarka |

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Danimarka

Sibutramin “1A Farma”

15 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danimarka |

Sandoz A/S

C. F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danimarka

Sibutramin “Sandoz”

10 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danimarka |

Sandoz A/S

C. F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danimarka

Sibutramin “Sandoz”

15 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| Teva Danimarka A/S |
| --- |
| Østergade 38 |
| DK-1100 København K |
| Danimarka |

Teva Danimarka A/S

Østergade 38

DK-1100 København K

Danimarka

Sibutramin “Teva”

10 mg

Kapsula, iebsa

Għal użu orali

Danimarka

| Teva Danimarka A/S |
| --- |
| Østergade 38 |
| DK-1100 København K |
| Danimarka |

Teva Danimarka A/S

Østergade 38

DK-1100 København K

Danimarka

Sibutramin “Teva”

15 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

REDUCTIL

10 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

REDUCTIL

15 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenja

SIBUTRIL

10 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenja

SIBUTRIL

15 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Zentiva, k.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| Republika Ċeka |

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Republika Ċeka

LINDAXA 10

10 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Zentiva, k.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| Republika Ċeka |

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Republika Ċeka

LINDAXA 15

15 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Olanda

SIBUTRAMINE TEVA

10 mg

Kapsula, iebsa

Għal użu orali

Estonja

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Olanda

SIBUTRAMINE TEVA

15 mg

Kapsula, iebsa

Għal użu orali

Finlandja

| Abbott Scandinavia AB |
| --- |
| P.O. Box 509 |
| 16929 Solna |
| Svezja |

Abbott Scandinavia AB

P.O. Box 509

16929 Solna

Svezja

Reductil

10 mg, 15 mg

Kapsula, iebsa

Għal użu orali

Finlandja

| Sandoz A/S C.F. |
| --- |
| Tietgens Boulevard 40 |
| 5220 Odense SØ |
| Danimarka |

Sandoz A/S C.F.

Tietgens Boulevard 40

5220 Odense SØ

Danimarka

Sibutramin Sandoz

10 mg, 15 mg

Kapsula, iebsa

Għal użu orali

Finlandja

| Teva Svezja AB |
| --- |
| Järnvägsgatan 11 |
| Box 1070 |
| 25110 Helsingborg |
| Svezja |

Teva Svezja AB

Järnvägsgatan 11

Box 1070

25110 Helsingborg

Svezja

Sibutramine Teva

10 mg, 15 mg

Kapsula, iebsa

Għal użu orali

Franza

| ABBOTT France |
| --- |
| 10, RUE D'ARCUEIL |
| SILIC 233 |
| 94528 RUNGIS CEDEX |
| Franza |

ABBOTT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

Franza

SIBUTRAL 10 mg, gélule

10 mg

Kapsula

Għal użu orali

Franza

| ABBOTT France |
| --- |
| 10, RUE D'ARCUEIL |
| SILIC 233 |
| 94528 RUNGIS CEDEX |
| Franza |

ABBOTT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

Franza

SIBUTRAL 15 mg, gélule

15 mg

Kapsula

Għal użu orali

Ġermanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil 10 mg Hartkapseln

10 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil 15 mg Hartkapseln

15 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Zelium 10 mg Hartkapseln

10 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Zelium 15 mg Hartkapseln

15 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reduxade 10 mg Hartkapseln

10 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reduxade 15 mg Hartkapseln

15 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Ġermanja |

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Ġermanja

Sibutramin - 1A Pharma 10 mg Hartkapseln

10 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Ġermanja |

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Ġermanja

Sibutramin - 1A Pharma 15 mg Hartkapseln

15 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| Ġermanja |

HEXAL AG

Postfach 1263

83602 Holzkirchen

Ġermanja

Sibutramin-HEXAL 10 mg Hartkapseln

10 mg

Kapsula, iebsa

Għal użu orali

Ġermanja

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| Ġermanja |

HEXAL AG

Postfach 1263

83602 Holzkirchen

Ġermanja

Sibutramin-HEXAL 15 mg Hartkapseln

15 mg

Kapsula, iebsa

Għal użu orali

Greċja

| Abbott Laboratories (Hellas) S.A. |
| --- |
| 512, Vouliagmenis Avenue |
| GR 17456, Alimos |
| Ateni |
| Greċja |

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Ateni

Greċja

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Greċja

| Abbott Laboratories (Hellas) S.A. |
| --- |
| 512, Vouliagmenis Avenue |
| GR 17456, Alimos |
| Ateni |
| Greċja |

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Ateni

Greċja

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Greċja

| Teva Pharmaceuticals Europe B.V. |
| --- |
| European Headquarters |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

Olanda

Sibutramine/Teva

10 mg

Kapsula, iebsa

Għal użu orali

Greċja

| Teva Pharmaceuticals Europe B.V. |
| --- |
| European Headquarters |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

Olanda

Sibutramine/Teva

15 mg

Kapsula, iebsa

Għal użu orali

Ungerija

| Zentiva k. s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Republika Ċeka |

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Republika Ċeka

LINDAXA

10 mg

Kapsula, iebsa

Għal użu orali

Hungary

| Zentiva k. s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Republika Ċeka |

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Republika Ċeka

LINDAXA

15 mg

Kapsula, iebsa

Għal użu orali

Hungary

| Teva Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Ungerija |

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Ungerija

MINIMECTIL

10 mg

Kapsula, iebsa

Għal użu orali

Hungary

| Teva Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Ungerija |

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Ungerija

MINIMECTIL

15 mg

Kapsula, iebsa

Għal użu orali

Hungary

| Abbott Laboratories Kft. |
| --- |
| Teve u. 1/a-c |
| 1139 Budapest |
| Ungerija |

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Ungerija

REDUCTIL

10 mg

Kapsula, iebsa

Għal użu orali

Hungary

| Abbott Laboratories Kft. |
| --- |
| Teve u. 1/a-c |
| 1139 Budapest |
| Ungerija |

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Ungerija

REDUCTIL

15 mg

Kapsula, iebsa

Għal użu orali

Iceland

| Abbott Scandinavia |
| --- |
| Gårdsvägen 8 |
| Box 5091 |
| SE-169 29 Solna |
| Svezja |

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Svezja

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Iceland

| Abbott Scandinavia |
| --- |
| Gårdsvägen 8 |
| Box 5091 |
| SE-169 29 Solna |
| Svezja |

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Svezja

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Ireland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 Dr Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Olanda

Sibutramine Teva 10 mg Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Ireland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 Dr Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Olanda

Sibutramine Teva 15 mg Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

Ireland

| Abbott Laboratories Ireland Ltd |
| --- |
| 4051 Kingswood Drive |
| Citywest Business Campus |
| Dublin 24 |
| Irlanda |

Abbott Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Irlanda

Reductil 10 mg Kapsuli, hard

10 mg

Kapsula, iebsa

Għal użu orali

Ireland

| Abbott Laboratories Ireland Ltd |
| --- |
| 4051 Kingswood Drive |
| Citywest Business Campus |
| Dublin 24 |
| Irlanda |

Abbott Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Irlanda

Reductil 15 mg Kapsuli, hard

15 mg

Kapsula, iebsa

Għal użu orali

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co.Cork |
| Irlanda |

Rowex Ltd

Bantry

Co.Cork

Irlanda

Sitrane 10 mg hard Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Ireland

| Rowex Ltd |
| --- |
| Bantry |
| Co.Cork |
| Irlanda |

Rowex Ltd

Bantry

Co.Cork

Irlanda

Sitrane 15 mg hard Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

Italja

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italja |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italja

REDUXATE

10 mg

Kapsula

Għal użu orali

Italja

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italja |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italja

REDUXATE

15 mg

Kapsula

Għal użu orali

Italja

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italja |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italja

ECTIVA

10 mg

Kapsula

Għal użu orali

Italja

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italja |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italja

ECTIVA

15 mg

Kapsula

Għal użu orali

Italja

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italja |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italja

REDUCTIL

10 mg

Kapsula

Għal użu orali

Italja

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italja |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italja

REDUCTIL

15 mg

Kapsula

Għal użu orali

Latvija

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil 15 mg hard Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

Latvija

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil 10 mg hard Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Latvija

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenja

Sibutril 15 mg Kapsuli, hard

15 mg

Kapsula, iebsa

Għal użu orali

Latvija

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenja

Sibutril 10 mg Kapsuli, hard

10 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Zentiva k. s. |
| --- |
| U kabelovny 130 |
| 10237 Prague 10 Dolni Mecholupy Republika Ċeka |

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Republika Ċeka

Lindaxa

10 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Zentiva k. s. |
| --- |
| U kabelovny 130 |
| 10237 Prague 10 Dolni Mecholupy Republika Ċeka |

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Republika Ċeka

Lindaxa

15 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenja

Sibutril

10 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenja |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenja

Sibutril

15 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Olanda

Sibutramine Teva

10 mg

Kapsula, iebsa

Għal użu orali

Litwanja

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Olanda |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Olanda

Sibutramine Teva

15 mg

Kapsula, iebsa

Għal użu orali

Lussemburgu

| Abbott Laboratoires |
| --- |
| 2, rue du Bosquet |
| B- 1348 Ottignies L.L.N. |
| Belgium |

Abbott Laboratoires

2, rue du Bosquet

B- 1348 Ottignies L.L.N.

Belgium

Reductil

10 mg

Kapsula

Għal użu orali

Lussemburgu

| Abbott Laboratoires |
| --- |
| 2, rue du Bosquet |
| B- 1348 Ottignies L.L.N. |
| Belgium |

Abbott Laboratoires

2, rue du Bosquet

B- 1348 Ottignies L.L.N.

Belgium

Reductil

15 mg

Kapsula

Għal użu orali

Malta

| Abbott Laboratories Limited Queenborough |
| --- |
| Kent |
| ME11 5EL |
| Renju Unit |

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

Renju Unit

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Malta

| Abbott Laboratories Limited Queenborough |
| --- |
| Kent |
| ME11 5EL |
| Renju Unit |

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

Renju Unit

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Abbott B.V. |
| --- |
| Siriusdreef 51 |
| 2132 WT, Hoofddorp |
| Olanda |

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Olanda

Reductil 10 mg, Kapsuli, hard

10 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Abbott B.V. |
| --- |
| Siriusdreef 51 |
| 2132 WT, Hoofddorp |
| Olanda |

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Olanda

Reductil 15 mg, Kapsuli, hard

15 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH, Almere |
| Olanda |

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Olanda

Sibutramine HCL monohydraat Sandoz 10 mg, harde Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH, Almere |
| Olanda |

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Olanda

Sibutramine HCL monohydraat Sandoz 15 mg, harde Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Medcor Pharmaceuticals B.V.Ketelmeerstraat 142-144 |
| --- |
| 8226 JX, Lelystad |
| Olanda |

Medcor Pharmaceuticals B.V.Ketelmeerstraat 142-144

8226 JX, Lelystad

Olanda

Reductil 15 mg, Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Medcor Pharmaceuticals B.V.Ketelmeerstraat 142-144 |
| --- |
| 8226 JX, Lelystad |
| Olanda |

Medcor Pharmaceuticals B.V.Ketelmeerstraat 142-144

8226 JX, Lelystad

Olanda

Reductil 10 mg, Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA, Haarlem |
| Olanda |

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Olanda

Sibutramine HCL- monohydraat 10 mg PCH, Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Olanda

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA, Haarlem |
| Olanda |

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Olanda

Sibutramine HCL- monohydraat 15 mg PCH, Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

Norveġja

| Abbott Scandinavia |
| --- |
| AB Box 509 |
| 169 29 Solna |
| Svezja |

Abbott Scandinavia

AB Box 509

169 29 Solna

Svezja

REDUCTIL

10 mg

Kapsula, iebsa

Għal użu orali

Norveġja

| Abbott Scandinavia |
| --- |
| AB Box 509 |
| 169 29 Solna |
| Svezja |

Abbott Scandinavia

AB Box 509

169 29 Solna

Svezja

REDUCTIL

15 mg

Kapsula, iebsa

Għal użu orali

Norveġja

| Euromedica Norge AS |
| --- |
| Jerikoveien 28 C |
| 1067 Oslo |
| Norveja |

Euromedica Norge AS

Jerikoveien 28 C

1067 Oslo

Norveja

REDUCTIL

10 mg

Kapsula, iebsa

Għal użu orali

Norveġja

| Euromedica Norge AS |
| --- |
| Jerikoveien 28 C |
| 1067 Oslo |
| Norveja |

Euromedica Norge AS

Jerikoveien 28 C

1067 Oslo

Norveja

REDUCTIL

15 mg

Kapsula, iebsa

Għal użu orali

Norveġja

| Sandoz A/ |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 København S |
| Danimarka |

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danimarka

SIBUTRAMIN SANDOZ

10 mg

Kapsula, iebsa

Għal użu orali

Norveġja

| Sandoz A/ |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 København S |
| Danimarka |

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danimarka

SIBUTRAMIN SANDOZ

15 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| 53 Emilii Plater St. |
| 00-113 Warsaw |
| Polonja |

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Polonja

Afibron

10 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| 53 Emilii Plater St. |
| 00-113 Warsaw |
| Polonja |

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Polonja

Afibron

15 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Praha 10 |
| Republika Ċeka |

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Republika Ċeka

Lindaxa 10

10 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Praha 10 |
| Republika Ċeka |

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Republika Ċeka

Lindaxa 15

15 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Abbott Laboratories Polonja Sp. z o. o. |
| --- |
| ul. Postępu 18A |
| 02-676 Warsaw |
| Polonja |

Abbott Laboratories Polonja Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Polonja

Meridia 10

10 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Abbott Laboratories Polonja Sp. z o. o. |
| --- |
| ul. Postępu 18A |
| 02-676 Warsaw |
| Polonja |

Abbott Laboratories Polonja Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Polonja

Meridia 15

15 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Awstrija

Obesan

10 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Awstrija |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Awstrija

Obesan

15 mg

Kapsula, iebsa

Għal użu orali

Polonja

| 1A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Ġermanja |

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Ġermanja

Sibutramine-1A Pharma

10 mg

Kapsula, iebsa

Għal użu orali

Polonja

| 1A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Ġermanja |

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Ġermanja

Sibutramine-1A Pharma

15 mg

Kapsula, iebsa

Għal użu orali

Polonja

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198 |
| Poznan |
| Polonja |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Polonja

Zelixa

10 mg

Film-coated tablet

Għal użu orali

Polonja

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198 |
| Poznan |
| Polonja |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Polonja

Zelixa

15 mg

Film-coated tablet

Għal użu orali

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Zelium

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Zelium

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| ABBOTT LABORATORIOS, LDA |
| --- |
| Estrada Alfragide 67-AlfraparK-Edifício D, |
| 2610-008 AMADORA |
| Portugal |

ABBOTT LABORATORIOS, LDA

Estrada Alfragide 67-AlfraparK-Edifício D,

2610-008 AMADORA

Portugal

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Teva Pharma – |
| --- |
| Produtos Farmacêuticos, Lda. |
| Empreendimento Lagoas Park |
| Edifício 1 - 3 |
| 2740-264 Porto Salvo |
| Portugal |

Teva Pharma –

Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 1 - 3

2740-264 Porto Salvo

Portugal

Sibutramina Teva

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Teva Pharma – |
| --- |
| Produtos Farmacêuticos, Lda. |
| Empreendimento Lagoas Park |
| Edifício 1 - 3 |
| 2740-264 Porto Salvo |
| Portugal |

Teva Pharma –

Produtos Farmacêuticos, Lda.

Empreendimento Lagoas Park

Edifício 1 - 3

2740-264 Porto Salvo

Portugal

Sibutramina Teva

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda. |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda.

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Sibulaite

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Sibulaite

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Solufarma

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Solufarma - Produtos Farmacêuticos Unipessoal, Lda |
| --- |
| Rua do Tejo, 56 - 9o A Esq |
| 2775-325 Parede |
| Portugal |

Solufarma - Produtos Farmacêuticos Unipessoal, Lda

Rua do Tejo, 56 - 9o A Esq

2775-325 Parede

Portugal

Sibutramina Solufarma

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Farmoz

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Farmoz - Sociedade Técnico Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Farmoz - Sociedade Técnico Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Farmoz

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no2 -Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 -Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no2 Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no2 Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Atrolex

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Atrolex

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Argam

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Argam

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Orexinib

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Orexinib

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Snomas

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Snomas

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Arpedex

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Arpedex

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Marcoliz

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Marcoliz

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Ocram

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Ocram

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda |
| --- |
| Av. Sidónio Pais, n.o 24, |
| rés-do-chão esq |
| São Sebastião da Pedreira |
| 1000 Lisboa |
| Portugal |

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda

Av. Sidónio Pais, n.o 24,

rés-do-chão esq

São Sebastião da Pedreira

1000 Lisboa

Portugal

Sibutramina Strami

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda |
| --- |
| Av. Sidónio Pais, n.o 24, |
| rés-do-chão esq, |
| São Sebastião da Pedreira |
| 1000 Lisboa |
| Portugal |

Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda

Av. Sidónio Pais, n.o 24,

rés-do-chão esq,

São Sebastião da Pedreira

1000 Lisboa

Portugal

Sibutramina Strami

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Fililex

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina Fililex

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina West Pharma

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Tecnimede - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, 2 |
| Abrunheira |
| 2710-089 Sintra |
| Portugal |

Tecnimede - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, 2

Abrunheira

2710-089 Sintra

Portugal

Sibutramina West Pharma

15 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, |
| Edifício 4, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura,

Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Sibutramina Generis

8,37 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura, |
| Edifício 4, |
| Quinta da Beloura |
| 2710-444 Sintra |
| Portugal |

Generis Farmacêutica, S.A.

Office Park da Beloura,

Edifício 4,

Quinta da Beloura

2710-444 Sintra

Portugal

Sibutramina Generis

12,556 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, |
| Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura,

Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Sibutramina Sandoz

10 mg

Kapsula, iebsa

Għal użu orali

Portugal

| Sandoz Farmacêutica, Lda. |
| --- |
| Alameda da Beloura, Edifício 1, 2o - Escritório 15 |
| 2710-693 Sintra |
| Portugal |

Sandoz Farmacêutica, Lda.

Alameda da Beloura, Edifício 1, 2o - Escritório 15

2710-693 Sintra

Portugal

Sibutramina Sandoz

15 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

REDUCTIL 10 mg, capsule

10 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Ġermanja |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Ġermanja

REDUCTIL 15 mg, capsule

15 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| SANDOZ S.R.L. ROMÂNIA |
| --- |
| Str. Livezeni nr. 7A, |
| Târgu Mureș, |
| Rumanija |

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureș,

Rumanija

MINIMACIN 10 mg, capsule

10 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| SANDOZ S.R.L. ROMÂNIA |
| --- |
| Str. Livezeni nr. 7A, |
| Târgu Mureș, |
| Rumanija |

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureș,

Rumanija

MINIMACIN 15 mg, capsule

15 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii, nr. 124, |
| Cluj-Napoca, |
| Rumanija |

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Rumanija

SILUTON 10 mg, capsule

10 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii, nr. 124, |
| Cluj-Napoca, |
| Rumanija |

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Rumanija

SILUTON 15 mg, capsule

15 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra nr 12, parter, |
| Sector 2, București |
| Rumanija |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra nr 12, parter,

Sector 2, București

Rumanija

SIBUTRAMINĂ TEVA 10 mg, capsule

10 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra nr 12, parter, |
| Sector 2, București |
| Rumanija |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra nr 12, parter,

Sector 2, București

Rumanija

SIBUTRAMINĂ TEVA 15 mg, capsule

15 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| ZENTIVA a.s., |
| --- |
| U kabelovny 130, |
| 102 37 Praga-10 Dolní Měcholupy, Republika Ċeka |

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy, Republika Ċeka

LINDAXA 10 mg, capsule

10 mg

Kapsula, iebsa

Għal użu orali

Rumanija

| ZENTIVA a.s., |
| --- |
| U kabelovny 130, |
| 102 37 Praga-10 Dolní Měcholupy |
| Republika Ċeka |

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy

Republika Ċeka

LINDAXA 15 mg, capsule

15 mg

Kapsula, iebsa

Għal użu orali

Slovakkja

| Zentiva, k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Republika Ċeka |

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Republika Ċeka

LINDAXA 10

10 mg

Kapsula, iebsa

Għal użu orali

Slovakkja

| Zentiva, k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Republika Ċeka |

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Republika Ċeka

LINDAXA 15

15 mg

Kapsula, iebsa

Għal użu orali

Slovakkja

| TEVA Pharmaceuticals Slovakkja s.r.o. |
| --- |
| Teslova 26, 821 02, Bratislava |
| Republika Slovakka |

TEVA Pharmaceuticals Slovakkja s.r.o.

Teslova 26, 821 02, Bratislava

Republika Slovakka

Sibutramin - Teva 10 mg kapsuly

10 mg

Kapsula, iebsa

Għal użu orali

Slovakkja

| TEVA Pharmaceuticals Slovakkja s.r.o. |
| --- |
| Teslova 26, 821 02, Bratislava |
| Republika Slovakka |

TEVA Pharmaceuticals Slovakkja s.r.o.

Teslova 26, 821 02, Bratislava

Republika Slovakka

Sibutramin - Teva 15 mg kapsuly

15 mg

Kapsula, iebsa

Għal użu orali

Slovakkja

| Abbott Laboratories Slovakkja s.r.o. |
| --- |
| Karadžicova 10 |
| 821 08 Bratislava |
| Republika Slovakka |

Abbott Laboratories Slovakkja s.r.o.

Karadžicova 10

821 08 Bratislava

Republika Slovakka

Reductil 10 mg

10 mg

Kapsula

Għal użu orali

Slovakkja

| Abbott Laboratories Slovakkja s.r.o. |
| --- |
| Karadžicova 10 |
| 821 08 Bratislava |
| Republika Slovakka |

Abbott Laboratories Slovakkja s.r.o.

Karadžicova 10

821 08 Bratislava

Republika Slovakka

Reductil 15 mg

15 mg

Kapsula

Għal użu orali

Slovenja

| Abbott Laboratories d.o.o. |
| --- |
| Dolenjska c. 242c |
| SI-1000 Ljubljana |
| Slovenja |

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI-1000 Ljubljana

Slovenja

Reductil 10 mg trde kapsule

10 mg

Kapsula, iebsa

Għal użu orali

Slovenja

| Abbott Laboratories d.o.o. |
| --- |
| Dolenjska c. 242c |
| SI-1000 Ljubljana |
| Slovenja |

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI-1000 Ljubljana

Slovenja

Reductil 15 mg trde kapsule

15 mg

Kapsula, iebsa

Għal użu orali

Slovenja

| Lek farmacevtska družba d.d., Verovškova c. 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenja |

Lek farmacevtska družba d.d., Verovškova c. 57

SI-1000 Ljubljana

Slovenja

Sibutramin Lek 10 mg trde kapsule

10 mg

Kapsula, iebsa

Għal użu orali

Slovenja

| Lek farmacevtska družba d.d., Verovškova c. 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenja |

Lek farmacevtska družba d.d., Verovškova c. 57

SI-1000 Ljubljana

Slovenja

Sibutramin Lek 15 mg trde kapsule

15 mg

Kapsula, iebsa

Għal użu orali

Spanja

| ABBOTT LABORATORIES, S.A. |
| --- |
| Avda. de Burgos |
| 28050 Madrid |
| Spanja |

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spanja

REDUCTIL

10 mg

Kapsula, iebsa

Għal użu orali

Spanja

| ABBOTT LABORATORIES, S.A. |
| --- |
| Avda. de Burgos |
| 28050 Madrid |
| Spanja |

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spanja

REDUCTIL

15 mg

Kapsula, iebsa

Għal użu orali

Spanja

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzmán el Bueno 133 |
| Edificio Britania 4oIzq. |
| 28003 MADRID |
| Spanja |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spanja

SIBUTRAMINA TEVA

10 mg

Kapsula, iebsa

Għal użu orali

Spanja

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzmán el Bueno 133 |
| Edificio Britania 4oIzq. |
| 28003 MADRID |
| Spanja |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spanja

SIBUTRAMINA TEVA

15 mg

Kapsula, iebsa

Għal użu orali

Spanja

| IDIFARMA, DESARROLLO FARMACEUTICO |
| --- |
| Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) |
| Spanja |

IDIFARMA, DESARROLLO FARMACEUTICO

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spanja

SIBUTRAMINA IDIFARMA

10 mg

Kapsula, iebsa

Għal użu orali

Spanja

| IDIFARMA, DESARROLLO FARMACEUTICO. |
| --- |
| Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) |
| Spanja |

IDIFARMA, DESARROLLO FARMACEUTICO.

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spanja

SIBUTRAMINA IDIFARMA

15 mg

Kapsula, iebsa

Għal użu orali

Svezja

| Abbott Scandinavia AB |
| --- |
| Box 509 169 29 Solna |
| Svezja |

Abbott Scandinavia AB

Box 509 169 29 Solna

Svezja

Reductil

10 mg

Kapsula, iebsa

Għal użu orali

Svezja

| Abbott Scandinavia AB |
| --- |
| Box 509 169 29 Solna |
| Svezja |

Abbott Scandinavia AB

Box 509 169 29 Solna

Svezja

Reductil

15 mg

Kapsula, iebsa

Għal użu orali

Svezja

| Sandoz A/S, C.F. |
| --- |
| Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danimarka |

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK-5220 Odense SØ

Danimarka

Sibutramin Sandoz

10 mg

Kapsula, iebsa

Għal użu orali

Svezja

| Sandoz A/S, C.F. |
| --- |
| Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danimarka |

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK-5220 Odense SØ

Danimarka

Sibutramin Sandoz

15 mg

Kapsula, iebsa

Għal użu orali

Svezja

| Teva Svezja AB |
| --- |
| Box 1070 |
| 251 10 Helsingborg |
| Svezja |

Teva Svezja AB

Box 1070

251 10 Helsingborg

Svezja

Sibutramine Teva

10 mg

Kapsula, iebsa

Għal użu orali

Svezja

| Teva Svezja AB |
| --- |
| Box 1070 |
| 251 10 Helsingborg |
| Svezja |

Teva Svezja AB

Box 1070

251 10 Helsingborg

Svezja

Sibutramine Teva

15 mg

Kapsula, iebsa

Għal użu orali

Renju Unit

| Abbott Laboratories Limited |
| --- |
| Queenborough |
| Kent ME11 5EL |
| Renju Unit |

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

Renju Unit

Reductil 10 mg

10 mg

Kapsula, iebsa

Għal użu orali

Renju Unit

| Abbott Laboratories Limited |
| --- |
| Queenborough |
| Kent ME11 5EL |
| Renju Unit |

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

Renju Unit

Reductil 15 mg

15 mg

Kapsula, iebsa

Għal użu orali

Renju Unit

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne, East Sussex BN22 9AG |
| Renju Unit |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne, East Sussex BN22 9AG

Renju Unit

Sibutramine Hydrochloride 10 mg Kapsuli

10 mg

Kapsula, iebsa

Għal użu orali

Renju Unit

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne, East Sussex BN22 9AG |
| Renju Unit |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne, East Sussex BN22 9AG

Renju Unit

Sibutramine Hydrochloride 15 mg Kapsuli

15 mg

Kapsula, iebsa

Għal użu orali

---

ANNESS XVI

LISTA TAL-ISEM, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI VETERINARJU, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT, MOD TA’ AMMINISTRAZZJONI, DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Applikant jew Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem kummerċjali tal-Prodott | Għamla Farmaċewtika | Qawwa | Speċi li fuqhom għandu jintuża l-prodott | Frekwenza u mod ta’ amministrazzjoni | Doża rrakkomandata | Perjodu ta’ tiżmim |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Ir-Renju Unit | CEVA Animal Health Limited | Tildren 500 mg lyophilisate għal soluzzjoni għal infużjoni | Lyophilisate għal soluzzjoni għal infużjoni | 500 mg | Żwiemel | Darba (il-kura tista’ tiġi ripetuta fuq parir tal-kirurgu veterinarju)
  Użu għal ġol-vina. | 1 mg/kg piż korporali (5 ml soluzzjoni rikostitwita għal kull 100 kg) | Żero jiem
  Mhux permess għall-użu f’annimali li jipproduċu l-ħalib għall-konsum mill-bniedem |
| Il-Ġermanja | CEVA Animal Health Limited | Tildren 500 mg lyophilisate għal soluzzjoni għal infużjoni | Lyophilisate għal soluzzjoni għal infużjoni | 500 mg | Żwiemel | Darba (il-kura tista’ tiġi ripetuta fuq parir tal-kirurgu veterinarju)
  Użu għal ġol-vina. | 1 mg/kg piż korporali (5 ml soluzzjoni rikostitwita għal kull 100 kg) | Żero jiem
  Mhux permess għall-użu f’annimali li jipproduċu l-ħalib għall-konsum mill-bniedem |

Stat Membru

Applikant jew Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem kummerċjali tal-Prodott

Għamla Farmaċewtika

Qawwa

Speċi li fuqhom għandu jintuża l-prodott

Frekwenza u mod ta’ amministrazzjoni

Doża rrakkomandata

Perjodu ta’ tiżmim

Ir-Renju Unit

CEVA Animal Health Limited

Tildren 500 mg lyophilisate għal soluzzjoni għal infużjoni

Lyophilisate għal soluzzjoni għal infużjoni

500 mg

Żwiemel

Darba (il-kura tista’ tiġi ripetuta fuq parir tal-kirurgu veterinarju)

Użu għal ġol-vina.

1 mg/kg piż korporali (5 ml soluzzjoni rikostitwita għal kull 100 kg)

Żero jiem

Mhux permess għall-użu f’annimali li jipproduċu l-ħalib għall-konsum mill-bniedem

Il-Ġermanja

CEVA Animal Health Limited

Tildren 500 mg lyophilisate għal soluzzjoni għal infużjoni

Lyophilisate għal soluzzjoni għal infużjoni

500 mg

Żwiemel

Darba (il-kura tista’ tiġi ripetuta fuq parir tal-kirurgu veterinarju)

Użu għal ġol-vina.

1 mg/kg piż korporali (5 ml soluzzjoni rikostitwita għal kull 100 kg)

Żero jiem

Mhux permess għall-użu f’annimali li jipproduċu l-ħalib għall-konsum mill-bniedem

---

ANNESS XVII

LISTA TAL-ISMIJIET IVVINTATI, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINAGĦATA, U D-DETENTURI TA’ L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI (EEA)

| Stat Membru | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat Isem | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Dermapharm GmbH |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Stat Membru

Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

Isem Ivvintat Isem

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Creme

50 mg/g

Krema

Użu għall-ġilda

L-Awstrija

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - dermatologische Emulsion

50 mg/g

Emulsjoni għall-ġilda

Użu għall-ġilda

L-Awstrija

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Fettsalbe

50 mg/g

Ingwent

Użu għall-ġilda

L-Awstrija

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Salbe

50 mg/g

Ingwent

Użu għall-ġilda

Il-Bulgarija

| Stada Arzneimittel AG, |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG,

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S Forte

Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg

Suppositorju

Użu għal ġor-rektum

Il-Bulgarija

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S

Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g

Ingwent għar-rektum

Użu għal ġor-rektum

Ir-Repubblika Ceka

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

MASTU S FORTE

Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg

Suppositorju

Użu għal ġor-rektum

Ir-Repubblika Ceka

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

MASTU S

Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g

Ingwent għar-rektum

Użu għal ġor-rektum

Franza

| Pierre Fabre Medicament |
| --- |
| 45 place Abel Gance |
| 92654 Boulogne cedex |
| France |

Pierre Fabre Medicament

45 place Abel Gance

92654 Boulogne cedex

France

BUFAL 5 POUR CENT, crème en tube

5 g/100 g

Krema

Użu għall-ġilda

Franza

| Coopération Pharmaceutique Française |
| --- |
| Place Lucien Auvert |
| 77020 Melun cedex |
| France |

Coopération Pharmaceutique Française

Place Lucien Auvert

77020 Melun cedex

France

BUFEXAMAC COOPER 5 pour cent, crème

5 g/100 g

Krema

Użu għall-ġilda

Franza

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

BUFEXAMAC NOVALIS 5 pour cent, crème

5 g/100 g

Krema

Użu għall-ġilda

Franza

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

CALMADERM, crème pour application cutannée

5 g/100 g

Krema

Użu għall-ġilda

Franza

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

PARFENAC 5 POUR CENT, crème

5 g/100 g

Krema

Użu għall-ġilda

Franza

| Wyeth Pharmaceuticals France |
| --- |
| Cœur Défense Tour A |
| la Défanse 4 |
| 92931 Paris La Défense Cedex |
| France |

Wyeth Pharmaceuticals France

Cœur Défense Tour A

la Défanse 4

92931 Paris La Défense Cedex

France

PARFENOIDE, crème pour application locale

5 g/100 g

Krema

Użu għall-ġilda

L-Ungerija

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S

50 mg Bufexamac (+5 mg Lidocaine)/ 1g

Ingwent

Użu għall-ġilda

L-Ungerija

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S Forte

250 mg Bufexamac, +10 mg Lidocaine

Suppositorju

Użu għal ġor-rektum

L-Italja

| Farmigea spa |
| --- |
| Via Giovan Battista Oliva 6/8 |
| 56121 PISA |
| Italy |

Farmigea spa

Via Giovan Battista Oliva 6/8

56121 PISA

Italy

FANSAMAC

5 g/100 g

Krema

Użu għall-ġilda

Il-Latvja

| Stada Arzneimittel AG, |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG,

Stadastraße 2-18

61118 Bad Vilbel

Germany

Mastu S ointment

Bismuthi subgallas 50 mg, Bufexamacum 50 mg, Titanii dioxidum 50 mg Lidocaini hydrochloridum 5 mg/g

Ingwent

Użu għal ġor-rektum and Użu għall-ġilda

Il-Latvja

| Stada Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| 61118 Bad Vilbel, |
| Germany |

Stada Arzneimittel AG

Stadastraße 2-18

61118 Bad Vilbel,

Germany

Mastu S forte suppositories

Titanii dioxidum 250 mg, Lidocaini hydrochloridum 100 mg, Bismuthi subgallas 100 mg, Bufexamacum 10 mg

Suppositorju

Użu għal ġor-rektum

Il-Litwanja

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S

Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride monohydrate 5 mg/g

Ingwent

Użu għall-ġilda

Il-Litwanja

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

Mastu S forte

Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride monohydrate 10 mg

Suppositorju

Użu għal ġor-rektum

Il-Lussemburgu

| PF MEDICAMENT |
| --- |
| 45, Place Abel Gance |
| 92654 Boulogne Cedex |
| France |

PF MEDICAMENT

45, Place Abel Gance

92654 Boulogne Cedex

France

BUFAL

5 g/100g

Krema

Użu għall-ġilda

Il-Portugall

| Home Products de Portugal, Lda. Rua Dr. António Loureiro Borges |
| --- |
| 2 - Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Home Products de Portugal, Lda. Rua Dr. António Loureiro Borges

2 - Arquiparque - Miraflores

1495-131 Algés

Portugal

Parfenac

50 mg/g

Ingwent

Użu għall-ġilda

Ir-Rumanija

| STADA ARZNEIMITTEL AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA ARZNEIMITTEL AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

PROCTOSAN FORTE, suppository

250 mg

Suppositorju

Użu għal ġor-rektum

Ir-Rumanija

| STADA ARZNEIMITTEL AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Germany |

STADA ARZNEIMITTEL AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

PROCTOSAN, rectal cream

50 mg

Krema għar-rektum

Użu għal ġor-rektum

Is-Slovakkja

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2 - 18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

MASTU S

50 mg / 1 g

Ingwent għar-rektum

Użu għal ġor-rektum

Is-Slovakkja

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2 - 18 |
| 61118 Bad Vilbel |
| Germany |

STADA Arzneimittel AG

Stadastrasse 2 - 18

61118 Bad Vilbel

Germany

MASTU S forte

250 mg

Suppositorju

Użu għal ġor-rektum

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