# Den Europæiske Unions C 295/2010

| | ISSN 1725-2393
  doi:10.3000/17252393.C_2010.295.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 295 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 53. årgang29. oktober 2010 |

ISSN 1725-2393

doi:10.3000/17252393.C_2010.295.dan

Den Europæiske Unions

Tidende

C 295

Dansk udgave

Meddelelser og oplysninger

53. årgang29. oktober 2010

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| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2010/C 295/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2010 til 31. august 2010 (Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004) | 1 |
| 2010/C 295/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2010 til 31. august 2010 (Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
  eller artikel 38 i direktiv 2001/82/EF) | 17 |

Informationsnummer

Indhold

Side

IV   Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

2010/C 295/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2010 til 31. august 2010 (Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004

1

2010/C 295/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2010 til 31. august 2010 (Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
  eller artikel 38 i direktiv 2001/82/EF)

Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF

eller artikel 38 i direktiv 2001/82/EF

17

| DA | |
| --- | --- |

DA

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IV Oplysninger

OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER

Europa-Kommissionen

| 29.10.2010 | DA | Den Europæiske Unions Tidende | C 295/1 |
| --- | --- | --- | --- |

29.10.2010

DA

Den Europæiske Unions Tidende

C 295/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2010 til 31. august 2010

(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (1))

2010/C 295/01

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for beslutningen | Lægemidlets navn | INN-navn
  (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode
  (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.7.2010 | Daxas | roflumilast | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/10/636/001-003 | Filmovertrukket tablet | R03DX07 | 8.7.2010 |
| 27.7.2010 | Leflunomide medac | leflunomid | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | EU/1/10/637/001-009 | Filmovertrukket tablet | L04AA13 | 30.7.2010 |
| 27.7.2010 | Ozurdex | Dexamethason | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | EU/1/10/638/001 | Intravitrealt implantat i applikator | 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 | Pulver til infusionsvæske, opløsning | A16AB10 | 30.8.2010 |
| 31.8.2010 | PecFent | Fentanyl | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | EU/1/10/644/001-004 | Næsespray, opløsning | N02AB03 | 6.9.2010 |

Dato for beslutningen

Lægemidlets navn

INN-navn

(International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode

(Anatomical Therapeutic Chemical Code)

Dato for notifikation

5.7.2010

Daxas

roflumilast

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

EU/1/10/636/001-003

Filmovertrukket tablet

R03DX07

8.7.2010

27.7.2010

Leflunomide medac

leflunomid

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

EU/1/10/637/001-009

Filmovertrukket tablet

L04AA13

30.7.2010

27.7.2010

Ozurdex

Dexamethason

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

EU/1/10/638/001

Intravitrealt implantat i applikator

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

Pulver til infusionsvæske, opløsning

A16AB10

30.8.2010

31.8.2010

PecFent

Fentanyl

Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom

EU/1/10/644/001-004

Næsespray, opløsning

N02AB03

6.9.2010

—   Ændring af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 GmbH Binger 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 Ltd Ramsgate 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 | 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 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 KGaA Frankfurter 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 Belgique | 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, Ελλάδα | 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 |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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 GmbH Binger 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 Ltd Ramsgate 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

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 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 KGaA Frankfurter 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 Belgique

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, Ελλάδα

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

—   Udstedelse af markedsføringstilladelse (artikel 13 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Afslået

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Ændring af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Godkendt

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004): Afslået

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 26.8.2010 | Masivet | AB Science S.A. 3 avenue George V, 75008 Paris, France | EU/2/08/087/001-002 | 31.8.2010 |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

26.8.2010

Masivet

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

EU/2/08/087/001-002

31.8.2010

—   Tilbagekaldelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004)

| Dato for beslutningen | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 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 |

Dato for beslutningen

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Alle interesserede kan ved henvendelse på nedenstående adresse få tilsendt den offentlige evalueringsrapport om de pågældende lægemidler og de afgørelser, der er truffet vedrørende disse:

| 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)  EUT L 136 af 30.4.2004, s. 1.

---

| 29.10.2010 | DA | Den Europæiske Unions Tidende | C 295/17 |
| --- | --- | --- | --- |

29.10.2010

DA

Den Europæiske Unions Tidende

C 295/17

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. juli 2010 til 31. august 2010

(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
   (1)
  eller artikel 38 i direktiv 2001/82/EF
   (2))

2010/C 295/02

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for beslutningen | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 16.8.2010 | Porcilis M Hyo and associated names | Se bilaget I | Se bilaget I | 17.8.2010 |
| 16.8.2010 | Porcilis PRRS and associated names | Se bilaget II | Se bilaget II | 17.8.2010 |
| 7.7.2010 | Levact and associated names | Se bilaget III | Se bilaget III | 9.7.2010 |
| 26.8.2010 | Valproic acid/valproate | Se bilaget IV | Se bilaget IV | 30.8.2010 |
| 1.7.2010 | Gadolinium | Se bilaget V | Se bilaget V | 5.7.2010 |
| 13.7.2010 | Valtrex and associated names | Se bilaget VI | Se bilaget VI | 16.7.2010 |
| 27.7.2010 | Famvir and associated names | Se bilaget VII | Se bilaget VII | 28.7.2010 |
| 7.7.2010 | Vascace | Se bilaget VIII | Se bilaget VIII | 8.7.2010 |
| 13.7.2010 | Atacand and associated names | Se bilaget IX | Se bilaget IX | 16.7.2010 |
| 1.7.2010 | Sortis | Se bilaget X | Se bilaget X | 6.7.2010 |
| 1.7.2010 | Quinolones and Fluoroquinolones | Se bilaget XI | Se bilaget XI | 6.7.2010 |
| 26.8.2010 | Seroquel XR and associated names | Se bilaget XII | Se bilaget XII | 30.8.2010 |
| 27.7.2010 | Tiamutin premix and associated names | Se bilaget XIII | Se bilaget XIII | 28.7.2010 |
| 5.7.2010 | Daxas | Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Disse beslutninger er rettet til medlemsstaterne | 7.7.2010 |
| 27.7.2010 | Leflunomide medac | medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, D-20354 Hamburg, Deutschland | Disse beslutninger er rettet til medlemsstaterne | 29.7.2010 |
| 27.7.2010 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland | Disse beslutninger er rettet til medlemsstaterne | 28.7.2010 |
| 1.7.2010 | Retacrit | HOSPIRA Enterprises B.V., Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland | Disse beslutninger er rettet til medlemsstaterne | 9.7.2010 |
| 1.7.2010 | Silapo | STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland | Disse beslutninger er rettet til medlemsstaterne | 5.7.2010 |
| 5.7.2010 | Thelin | Encysive (UK) Limited, Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom | Disse beslutninger er rettet til medlemsstaterne | 7.7.2010 |

Dato for beslutningen

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

16.8.2010

Porcilis M Hyo and associated names

Se bilaget I

Se bilaget I

17.8.2010

16.8.2010

Porcilis PRRS and associated names

Se bilaget II

Se bilaget II

17.8.2010

7.7.2010

Levact and associated names

Se bilaget III

Se bilaget III

9.7.2010

26.8.2010

Valproic acid/valproate

Se bilaget IV

Se bilaget IV

30.8.2010

1.7.2010

Gadolinium

Se bilaget V

Se bilaget V

5.7.2010

13.7.2010

Valtrex and associated names

Se bilaget VI

Se bilaget VI

16.7.2010

27.7.2010

Famvir and associated names

Se bilaget VII

Se bilaget VII

28.7.2010

7.7.2010

Vascace

Se bilaget VIII

Se bilaget VIII

8.7.2010

13.7.2010

Atacand and associated names

Se bilaget IX

Se bilaget IX

16.7.2010

1.7.2010

Sortis

Se bilaget X

Se bilaget X

6.7.2010

1.7.2010

Quinolones and Fluoroquinolones

Se bilaget XI

Se bilaget XI

6.7.2010

26.8.2010

Seroquel XR and associated names

Se bilaget XII

Se bilaget XII

30.8.2010

27.7.2010

Tiamutin premix and associated names

Se bilaget XIII

Se bilaget XIII

28.7.2010

5.7.2010

Daxas

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

Disse beslutninger er rettet til medlemsstaterne

7.7.2010

27.7.2010

Leflunomide medac

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

Disse beslutninger er rettet til medlemsstaterne

29.7.2010

27.7.2010

Ozurdex

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

Disse beslutninger er rettet til medlemsstaterne

28.7.2010

1.7.2010

Retacrit

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

Disse beslutninger er rettet til medlemsstaterne

9.7.2010

1.7.2010

Silapo

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

Disse beslutninger er rettet til medlemsstaterne

5.7.2010

5.7.2010

Thelin

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

Disse beslutninger er rettet til medlemsstaterne

7.7.2010

—   Afvisning af en national markedsføringstilladelse

| Dato for beslutningen | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 22.7.2010 | Ciclosporin IDL | Se bilaget XIV | Se bilaget XIV | 29.7.2010 |

Dato for beslutningen

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

22.7.2010

Ciclosporin IDL

Se bilaget XIV

Se bilaget XIV

29.7.2010

—   Suspension af en national markedsføringstilladelse

| Dato for beslutningen | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 22.7.2010 | Ciclosporin IDL | Se bilaget XIV | Se bilaget XIV | 29.7.2010 |
| 6.8.2010 | Sibutramine | Se bilaget XV | Se bilaget XV | 10.8.2010 |
| 22.7.2010 | Tildren | Se bilaget XVI | Se bilaget XVI | 23.7.2010 |

Dato for beslutningen

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

22.7.2010

Ciclosporin IDL

Se bilaget XIV

Se bilaget XIV

29.7.2010

6.8.2010

Sibutramine

Se bilaget XV

Se bilaget XV

10.8.2010

22.7.2010

Tildren

Se bilaget XVI

Se bilaget XVI

23.7.2010

—   Ophævelse af en national markedsføringstilladelse

| Dato for beslutningen | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 27.7.2010 | Bufexamac | Se bilaget XVII | Se bilaget XVII | 29.7.2010 |

Dato for beslutningen

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

27.7.2010

Bufexamac

Se bilaget XVII

Se bilaget XVII

29.7.2010

---

(1)  EUT L 311 af 28.11.2001, s. 67.

(2)  EUT L 311 af 28.11.2001, s. 1.

---

ANNEX I

LISTE OVER VETERINÆRLÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, ADMINISTRATIONSVEJ, TILBAGEHOLDELSESTID, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSSTATERNE

| Medlemstat/EU | Indehaver af Markedsførings- tilladelsen | Lægemidlets navn | Styrke | Lægemiddelform | Dyre-arter | Indikationer | Tilbage-holdelses- tid |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Østrig | Intervet GmbH |
| Siemensstrasse 107 |
| 1210 Wien |
| Austria |

Medlemstat/EU

Indehaver af Markedsførings- tilladelsen

Lægemidlets navn

Styrke

Lægemiddelform

Dyre-arter

Indikationer

Tilbage-holdelses- tid

Østrig

Intervet GmbH

Siemensstrasse 107

1210 Wien

Austria

PORCILIS M HYO

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Belgien

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Cypern

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Tjekkiet

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Danmark

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Estland

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Finland

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Frankrig

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Tyskland

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

Intervet Deutschland GmbH

Postfach 1130

85701

Unterschleißheim Germany

Porcilis M Hyo

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Grækenland

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Ungarn

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Irland

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Italien

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Letland

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Litauen

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Luxembourg

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Norge

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

Polen

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

0 døgn

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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

Slovakiet

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

Slovenien

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

Spanien

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

Sverige

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

Holland

| 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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

England

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

Inaktiveret helcellekoncentrat af Mycoplasma hyopneumoniae stamme 11: ≥ 7.0 log2 Ab titer

Injektionsvæske, suspension

Svin (slagtesvin)

Til aktiv immunisering af svin for at reducere lungelæsioner forårsaget af infektion med Mycoplasma hyopneumoniae.

Zero days

---

ANNEX II

LISTE OVER DET VETERINÆRLÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, DYREARTER, ADMINISTRATIONSVEJ, TILBAGEHOLDELSESTID, INDEHAVER AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSSTATERNE

| Medlemstat/EU | Indehaver af Markedsførings-tilladelsen | Læge-midlets navn | Styrke | Lægemiddel-form | Dyre-arter | Indikationer | Tilbage-holdelses-tid |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Østrig | Intervet GmbH |
| Siemensstrasse 107 |
| 1210 Wien |
| Austria |

Medlemstat/EU

Indehaver af Markedsførings-tilladelsen

Læge-midlets navn

Styrke

Lægemiddel-form

Dyre-arter

Indikationer

Tilbage-holdelses-tid

Østrig

Intervet GmbH

Siemensstrasse 107

1210 Wien

Austria

Porcilis PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Belgien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Frankrig

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

INTERVET

RUE OLIVIER DE SERRES

ANGERS TECHNOPOLE

49071 BEAUCOUZE

France

PORCILIS PRRS IM

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Tyskland

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

Intervet Deutschland GmbH

Postfach 1130

85701 Unterschleißheim

Germany

Porcilis PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Grækenland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Irland

| 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

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Irland

| 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

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr.dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Italien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Porsilis PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr.dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Luxembourg

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr.dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

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

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Spanien

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

PORCILIS PRSS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr.dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

Holland

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

Intervet International BV

Wim de Körverstraat 35

5831 AN Boxmeer

Nederland

Porcilis PRRS

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr. dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

England

| 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

Levende svækket PRRS virus stamme DV: 104.0 - 106.3 TCID50 pr.dosis

Lyofilisat og solvens til injektionsvæske, suspension

Svin

Aktiv immunisering af klinisk raske svin i et PRRS-viruskontamineret miljø for at reducere viræmi forårsaget af infektion med europæiske PRRS virusstammer.

0 døgn

---

BILAG III

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsstat EU/EØS | Indehaver af markedsføringstilladelse | SærnavnNavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Astellas Pharma GmbH |
| Georg-Brauchle-Ring 64-66 |
| 80992 München |
| Tyskland |

Medlemsstat EU/EØS

Indehaver af markedsføringstilladelse

SærnavnNavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

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

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Belgien

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Danmark

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Ribomustin

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Finland

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Ribomustin

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Frankrig

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Tyskland

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Irland

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Italien

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Ribomustin

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Norge

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Polen

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Spanien

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Levact

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

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

Astellas Pharma GmbH

Georg-Brauchle-Ring 64-66

80992 München

Tyskland

Ribomustin

2,5 mg/ml

Pulver til koncentrat til infusionsvæske, opløsning

Intravenøs anvendelse

---

BILAG IV

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Gerot Pharmazeutika G.m.b.H |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Medlemsstat

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 150 mg - Kapseln

150 mg

Enterokapsler, bløde

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 200 mg - Kapseln

200 mg

Enterokapsler, bløde

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 300 mg - Kapseln

300 mg

Enterokapsler, bløde

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 300 mg - Filmtabletten

300 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 500 mg - Kapseln

500 mg

Enterokapsler, bløde

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 50 mg/ml - Sirup für Kinder

50 mg/ml

syrup

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 300 mg/ml - Lösung zum Einnehmen

300 mg/ml

Oral opløsning

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 300 mg - Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Østrig

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

Gerot Pharmazeutika G.m.b.H

Arnethgasse 3

A-1160 Wien

Østrig

Convulex 500 mg - Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine chrono retard 300 mg - Filmtabletten

300 mg

Depottabletter

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine chrono retard 500 mg - Filmtabletten

500 mg

Depottabletter

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 500-1 000 mg/Dosis - Retardgranulat

500 -1000 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 50-200 mg/Dosis - Retardgranulat

50 - 200 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 50-350 mg/Dosis - Retardgranulat

50 - 350 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 100 mg - Retardgranulat in Beuteln

100 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 1 000 mg - Retardgranulat in Beuteln

1 000 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 250 mg - Retardgranulat in Beuteln

250 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 50 mg - Retardgranulat in Beuteln

50 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 500 mg - Retardgranulat in Beuteln

500 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine Chronosphere 750 mg - Retardgranulat in Beuteln

750 mg

Depotgranulat

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine 300 mg - Filmtabletten

300 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

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

Sanofi-aventis GmbH

SATURN Tower,

Leonard-Bernstein-Str. 10

Vienna DC, A-1220 Wien

Østrig

Depakine 300 mg/ml - Tropfen

300 mg/ml

orale dråber, opløsning

Oral anvendelse

Østrig

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

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-G. 3

A-1140 Wien

Østrig

Natriumvalproat »ratiopharm« retard 300 mg - Filmtabletten

300 mg

Depottabletter

Oral anvendelse

Østrig

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

Ratiopharm Arzneimittel Vertriebs-GmbH

Albert-Schweitzer-G. 3

A-1140 Wien

Østrig

Natriumvalproat »ratiopharm« retard 500 mg - Filmtabletten

500 mg

Depottabletter

Oral anvendelse

Østrig

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

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Østrig

Natriumvalproat G.L. 300 mg - Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Østrig

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

G. L. Pharma GmbH

Schloßplatz 1

8502 Lannach

Østrig

Natriumvalproat G.L. 500 mg - Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Belgien

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

CONVULEX

50 mg/ml

syrup

Oral anvendelse

Belgien

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

CONVULEX 300

300 mg

Enterokapsel, hård

Oral anvendelse

Belgien

| NYCOMED BELGIUM N.V. |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

NYCOMED BELGIUM N.V.

Gentsesteenweg 615

1080 Brussels

Belgien

CONVULEX 500

500 mg

Enterokapsel, hård

Oral anvendelse

Belgien

| NYCOMED BELGIUM N.V |
| --- |
| Gentsesteenweg 615 |
| 1080 Brussels |
| Belgien |

NYCOMED BELGIUM N.V

Gentsesteenweg 615

1080 Brussels

Belgien

CONVULEX-150

150 mg

Enterokapsel, hård

Oral anvendelse

Belgien

| NYCOMED BELGIUM N.V |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgien |

NYCOMED BELGIUM N.V

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE

300 mg/ml

orale dråber, opløsning

Oral anvendelse

Belgien

| NYCOMED BELGIUM N.V |
| --- |
| Culliganlaan 1 C |
| 1831 Diegem |
| Belgien |

NYCOMED BELGIUM N.V

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE 300 MG/5 ML

300 mg/5 ml

syrup

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE CHRONO 300

200,00 mg/87,00 mg

Depottabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE CHRONO 500

333,00 mg/145,00 mg

Depottabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE CHRONO MICROGRANULES 0,33G/G

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

Depotgranulat

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE ENTERIC 150

150 mg

Enterotabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE ENTERIC 300

300 mg

Enterotabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKINE ENTERIC 500

500 mg

Enterotabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKOTE 250

269,10 mg

Enterotabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAKOTE 500

538,20 mg

Enterotabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

DEPAMIDE

300 mg

Enterotabletter

Oral anvendelse

Belgien

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade b22 |
| 1020 Laken |
| Belgien |

EUROGENERICS N.V.

Heizel Esplanade b22

1020 Laken

Belgien

VALPROATE RETARD EG 300 MG

200,00 mg/87,00 mg

Depottabletter

Oral anvendelse

Belgien

| EUROGENERICS N.V. |
| --- |
| Heizel Esplanade b22 |
| 1020 Laken |
| Belgien |

EUROGENERICS N.V.

Heizel Esplanade b22

1020 Laken

Belgien

VALPROATE RETARD EG 500 MG

333,00 mg/145,00 mg

Depottabletter

Oral anvendelse

Belgien

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgien |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgien

VALPROATE RETARD MYLAN 300 MG

300 mg

Depottabletter

Oral anvendelse

Belgien

| MYLAN BVBA/SPRL |
| --- |
| Terhulpsesteenweg 6A |
| 1560 Hoeilaart |
| Belgien |

MYLAN BVBA/SPRL

Terhulpsesteenweg 6A

1560 Hoeilaart

Belgien

VALPROATE RETARD MYLAN 500 MG

500 mg

Depottabletter

Oral anvendelse

Belgien

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgien

VALPROATE SANDOZ 300 MG

199,80 mg/87,00 mg

Depottabletter

Oral anvendelse

Belgien

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

SANDOZ N.V.

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgien

VALPROATE SANDOZ 500 MG

333,00 mg/145,00 mg

Depottabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

VALPROIM CHRONO 300

200,00 mg/87,00 mg

Depottabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

VALPROIM CHRONO 500

333,00 mg/145,00 mg

Depottabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

VALPROIM LA 300

300,00 mg

Enterotabletter

Oral anvendelse

Belgien

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

SANOFI-AVENTIS BELGIUM N.V.

Culliganlaan 1 C

1831 Diegem

Belgien

VALPROIM LA 500

500,00 mg

Enterotabletter

Oral anvendelse

Belgien

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

Kristina De Turck

KDT Consulting

Chaussée de Ninove 2

1540 Herne

Belgien

VALPROSTAT 300 MG

199,80 mg/87,00 mg

Depottabletter

Oral anvendelse

Belgien

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

Kristina De Turck

KDT Consulting

Chaussée de Ninove 2

1540 Herne

Belgien

VALPROSTAT 500 MG

333,00 mg/145,00 mg

Depottabletter

Oral anvendelse

Bulgarien

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

AWD. pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Tyskland

Convulsofin

333 mg

tablet

Oral anvendelse

Bulgarien

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

G.L.Pharma GmbH Schlossplatz 1,

A-8502 Lannach,

Østrig

Convulex chrono

500 mg

Depottabletter

Oral anvendelse

Bulgarien

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

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Østrig

Convulex chrono

300 mg

Depottabletter

Oral anvendelse

Bulgarien

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

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Østrig

Convulex

500 mg

Enterokapsel

Oral anvendelse

Bulgarien

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

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Østrig

Convulex

150 mg

Enterokapsel

Oral anvendelse

Bulgarien

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

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Østrig

Convulex

300 mg

Enterokapsel

Oral anvendelse

Bulgarien

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

G.L.Pharma GmbH Schlossplatz 1

A-8502 Lannach

Østrig

Convulex

50 mg/ml

syrup

Oral anvendelse

Bulgarien

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

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

Bulgarien

Depakine Chrono

300 mg

Depottabletter

Oral anvendelse

Bulgarien

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

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

Bulgarien

Depakine Chrono

500 mg

Depottabletter

Oral anvendelse

Bulgarien

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

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

Bulgarien

Depakine

5,764 g/100 ml

syrup

Oral anvendelse

Bulgarien

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

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

Bulgarien

Depakine

200 mg

Enterotabletter

Oral anvendelse

Bulgarien

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

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

Bulgarien

Depakine

500 mg

Enterotabletter

Oral anvendelse

Bulgarien

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

Depakine chronosphere

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Bulgarien

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

Depakine chronosphere

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Bulgarien

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

Depakine chronosphere

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Bulgarien

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

Depakine chronosphere

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONO

500 mg

tablet

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONOSPHERE

50 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONOSPHERE

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONOSPHERE

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONOSPHERE

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONOSPHERE

750 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Sanofi-Aventis Cyprus Ltd

Charalambou

Mouskou 14

2015 Strovolos

Cypern

DEPAKINE CHRONOSPHERE

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Cypern

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

Remedica Ltd

Aharnon street

P.O.Box 51706

3508 Lemesos

Cypern

PETILIN

500 mg

Enterotabletter

Oral anvendelse

Cypern

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

Remedica Ltd

Aharnon street

P.O.Box 51706

3508 Lemesos

Cypern

PETILIN

200 mg/5ml

syrup

Oral anvendelse

Tjekkiet

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor 300 mg

300 mg

Depottabletter

Oral anvendelse

Tjekkiet

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor 500 mg

500 mg

Depottabletter

Oral anvendelse

Tjekkiet

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

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Tjekkiet

DEPAKINE

5,764/100 ml

syrup

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX 300 mg / ml

300 mg/1 ml of drops

orale dråber, opløsning

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX

50 mg/ml

syrup

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX CR 300 mg

300 mg

Depottabletter

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX CR 500 mg

500 mg

Depottabletter

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX 150

150 mg

kapsel, blød

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX 300

300 mg

kapsel, blød

Oral anvendelse

Tjekkiet

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

G.L. Pharma GmbH

Schlossplatz 1

8502 Lannach

Østrig

CONVULEX 500

500 mg

kapsel, blød

Oral anvendelse

Tjekkiet

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

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Tjekkiet

DEPAKINE CHRONO 500 mg sécable

500 mg (333 mg/145 mg)

Tabletter med modificeret udløsning

Oral anvendelse

Tjekkiet

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

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Tjekkiet

DEPAKINE CHRONO 300 mg sécable

300 mg (199,8 mg/87 mg)

Tabletter med modificeret udløsning

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril 150

150 mg

Enterotabletter

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril 300

300 mg

Enterotabletter

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril 600

600 mg

Enterotabletter

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril long 150 mg

150 mg

Depotkapsler, hård

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril long 300 mg

300 mg

Depotkapsler, hård

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril long 500 mg

500 mg

Depottabletter

Oral anvendelse

Tjekkiet

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

Orfiril long 1 000 mg

1 000 mg

Depottabletter

Oral anvendelse

Tjekkiet

| SANDOZ GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Østrig |

SANDOZ GmbH

Biochemiestrasse 10

A-6250 Kundl

Østrig

Valproat Chrono Sandoz 300 mg

300 mg

(200 mg/87 mg)

Depottabletter

Oral anvendelse

Tjekkiet

| SANDOZ GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Østrig |

SANDOZ GmbH

Biochemiestrasse 10

A-6250 Kundl

Østrig

Valproat Chrono Sandoz 500 mg

500 mg

(333 mg/145 mg)

Depottabletter

Oral anvendelse

Tjekkiet

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

sanofi-aventis, s.r.o.

Hadovka Office Park

Evropská 846/176a

160 00 Praha 6

Tjekkiet

DEPAKINE CHRONOSPHERE 500 MG

500 mg

(333,30 mg/145,14 mg)

Granulat med modificeret udløsning

Oral anvendelse

Tjekkiet

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| Tyskland |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Tyskland

Valproat-ratiopharm Chrono 300 mg

300 mg

(200 mg/87 mg)

Depottabletter

Oral anvendelse

Tjekkiet

| ratiopharm GmbH |
| --- |
| Graf-Arco-Straße 3 |
| 89079 Ulm |
| Tyskland |

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Tyskland

Valproat-ratiopharm Chrono 500 mg

500 mg

(333 mg/145 mg)

Depottabletter

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine

100 mg

Enterotabletter

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine

300 mg

Enterotabletter

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine

500 mg

Enterotabletter

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine

200 mg/ml

Orale dråber

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine

60 mg/ml

Oral opløsning

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine Retard

300 mg

Enterotabletter

Oral anvendelse

Danmark

| Sanofi-aventis Danmark A/S |
| --- |
| Slotsmarken 13 |
| DK-2970 Hørsholm |
| Danmark |

Sanofi-aventis Danmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Danmark

Deprakine Retard

500 mg

Enterotabletter

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril

60 mg/ml

Oral opløsning

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril

300 mg

Enterotabletter

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril

600 mg

Enterotabletter

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril Long

150 mg

Depotkapsler

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril Long

300 mg

Depotkapsler

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril Long

500 mg

Depotgranulat

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril Long

1 000 mg

Depotgranulat

Oral anvendelse

Danmark

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

Desitin Arzneimittel Gmbh

Weg beim Jaeger 214

DE-22335 Hamburg

Tyskland

Orfiril Retard

300 mg

Depottabletter

Oral anvendelse

Danmark

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

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Danmark

Valproat »Hexal«

300 mg

Depottabletter

Oral anvendelse

Danmark

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

HEXAL A/S

Kanalholmen 8-12

DK-2650 Hvidovre

Danmark

Valproat »Hexal«

500 mg

Depottabletter

Oral anvendelse

Danmark

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danmark

Valproat »Sandoz«

300 mg

Depottabletter

Oral anvendelse

Danmark

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

Sandoz A/S

Edvard Thomsens Vej 14

DK-2300 København S

Danmark

Valproat »Sandoz«

500 mg

Depottabletter

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

300 mg

tablet

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

100 mg

Enterotabletter

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

300 mg

Enterotabletter

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

500 mg

Enterotabletter

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

200 mg/ml

orale dråber, opløsning

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine Retard

300 mg

Depottabletter

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine Retard

500 mg

Depottabletter

Oral anvendelse

Danmark

| Orion Corporation Orion Pharma |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Delepsine

60 mg/ml

Oral opløsning

Oral anvendelse

Estland

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Finland

ABSENOR

500 mg

Depottabletter

Oral anvendelse

Estland

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Finland

ABSENOR

300 mg

Depottabletter

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

50 mg/ml

syrup

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 150 MG

150 mg

Enterokapsler, bløde

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 300 MG

300 mg

Enterokapsler, bløde

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 300 MG/ML

300 mg/ml

orale dråber, opløsning

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH, |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH,

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 500 MG

500 mg

Enterokapsler, bløde

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX RETARD 300 MG

300 mg

Depottabletter

Oral anvendelse

Estland

| GEROT PHARMAZEUTIKA GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX RETARD 500 MG

500 mg

Depottabletter

Oral anvendelse

Estland

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

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estland

DEPAKINE

50 mg/1ml

syrup

Oral anvendelse

Estland

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

Sanofi-Aventis Estonia OÜ,

Pärnu mnt 139E/2

11317 Tallinn

Estland

DEPAKINE CHRONO 300 mg

300 mg

Depottabletter

Oral anvendelse

Estland

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

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estland

DEPAKINE CHRONO 500 mg

500 mg

Depottabletter

Oral anvendelse

Estland

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

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estland

DEPAKINE CHRONOSPHERE

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Estland

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

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estland

DEPAKINE CHRONOSPHERE

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Estland

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

Sanofi-Aventis Estonia OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estland

DEPAKINE CHRONOSPHERE

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL 150

150 mg

Enterotabletter

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL 300

300 mg

Enterotabletter

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL 600

600 mg

Enterotabletter

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL LONG 1 000 MG

1 000 mg

Depotgranulat

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL LONG 150 MG

150 mg

Depotkapsler, hård

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg,

Tyskland

ORFIRIL LONG 300 MG

300 mg

Depotkapsler, hård

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH,

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL LONG 500 MG

500 mg

Depotgranulat

Oral anvendelse

Estland

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335 Hamburg

Tyskland

ORFIRIL SAFT

60 mg/ml

Oral opløsning

Oral anvendelse

Estland

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

STADA ARZNEIMITTEL AG

Stadastr. 2-18

D-61118 Bad Vilbel

Tyskland

PRODEPA

500 mg

Depottabletter

Oral anvendelse

Estland

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Slovenia

VALPROATE SODIUM SANDOZ 300 MG

300 mg

Depottabletter

Oral anvendelse

Estland

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.,

Verovskova 57

1000 Ljubljana

Slovenia

VALPROATE SODIUM SANDOZ 500 MG

500 mg

Depottabletter

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

100 mg/dose

Depotgranulat

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

1 000 mg/dose

Depotgranulat

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

250 mg/dose

Depotgranulat

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

300 mg

Depottabletter

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

500 mg

Depottabletter

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

500 mg/dose

Depotgranulat

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

100 mg

Enterotabletter

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

300 mg

Enterotabletter

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

500 mg

Enterotabletter

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

60 mg/ml

Oral opløsning

Oral anvendelse

Finland

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

sanofi-aventis Oy

Huopalahdentie 24

B.O. Box 22

FI-00351 Helsinki

Finland

DEPRAKINE

200 mg/ml

orale dråber, opløsning

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

300 mg

Depottabletter

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

500 mg

Depottabletter

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

100 mg

Enterotabletter

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

300 mg

Enterotabletter

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

500 mg

Enterotabletter

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

60 mg/ml

Oral opløsning

Oral anvendelse

Finland

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

Orion Oyj

Orionintie 1

B.O. Box 65

FI-02201 Espoo

Finland

ABSENOR

200 mg/ml

orale dråber, opløsning

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

NATRIUMVALPRO-AATTI LONG DESITIN

150 mg

Depotkapsler, hård

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

NATRIUMVALPRO-AATTI LONG DESITIN

300 mg

Depotkapsler, hård

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

NATRIUMVALPRO-AATTI LONG DESITIN

1 000 mg/dose

Depotgranulat

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

NATRIUMVALPRO-AATTI LONG DESITIN

500 mg/dose

Depotgranulat

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL

60 mg/ml

Oral opløsning

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG

150 mg

Depotkapsler, hård

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG

300 mg

Depotkapsler, hård

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG

1 000 mg

Depotgranulat

Oral anvendelse

Finland

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG

500 mg

Depotgranulat

Oral anvendelse

Finland

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

Sandoz A/S

C.F. Tietgens Boulevard 40, 5220 Odense SØ Danmark

VALPROAT SANDOZ

300 mg

Depottabletter

Oral anvendelse

Finland

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

Sandoz A/S

C.F. Tietgens Boulevard 40, 5220 Odense SØ Danmark

VALPROAT SANDOZ

500 mg

Depottabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE

200 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE

500 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE

200 mg/ml

Oral opløsning

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONO

500 mg

prolonged-release Filmovertrukken tablet

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE

57,64 mg/ml

syrup

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAMIDE

300 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKOTE

125 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKOTE

250 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKOTE

500 mg

Enterotabletter

Oral anvendelse

Frankrig

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

VENIPHARM

4, BUREAUX DE LA COLLINE

92213 SAINT-CLOUD

Frankrig

IMASLAV LP

500 mg

Filmovertrukken depotablet

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

100 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

1 000 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

250 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

50 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

500 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

750 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

MICROPAKINE LP

0,33g/g

Depotgranulat

Oral anvendelse

Frankrig

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

ALTER

3, avenue de la Baltique

91140 Villebon Sur Yvette

Frankrig

VALPROATE DE SODIUM ALTER L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

ARROW GENERIQUES

26, avenue Tony Garnier

69007 Lyon

Frankrig

VALPROATE DE SODIUM ARROW L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

BIOGARAN

15, boulevard Charles de Gaulle

92700 Colombes

Frankrig

VALPROATE DE SODIUM BIOGARAN L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret FRANKRIG

VALPROATE DE SODIUM GNR LP

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

| EG LABO - LABORATOIRES EUROGENERICS |
| --- |
| »Le Quintet« - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Frankrig |

EG LABO - LABORATOIRES EUROGENERICS

»Le Quintet« - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

Frankrig

VALPROATE DE SODIUM EG L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM DAKOTA PHARM,

200 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM DAKOTA PHARM,

500 mg

Enterotabletter

Oral anvendelse

Frankrig

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

MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

Frankrig

VALPROATE DE SODIUM MYLAN L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

QUALIMED (LYON)

117, allée des Parcs

69800 Saint-Priest

Frankrig

VALPROATE DE SODIUM QUALIMED L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

RATIOPHARM (ALLEMAGNE)

Graf Arco Strasse 3

89079 Ulm

Tyskland

VALPROATE DE SODIUM RATIOPHARM L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

RANBAXY PHARMACIE GENERIQUES

11-15 Quai Dion Bouton

92800 Puteaux

Frankrig

VALPROATE DE SODIUM RPG L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

SANDOZ

49, avenue Georges Pompidou

92300 Levallois-Perret

Frankrig

VALPROATE DE SODIUM SANDOZ L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

TEVA CLASSICS

Le Palatin 1

92936 Paris la Défense Cedex

Frankrig

VALPROATE DE SODIUM TEVA L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM WINTHROP

20 %

Oral opløsning

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM WINTHROP

200 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM WINTHROP

500 mg

Enterotabletter

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM WINTHROP L.P.

500 mg

Filmovertrukken depottablet

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

100 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

1 000 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

250 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

50 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

500 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P.

750 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

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

100 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

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

1 000 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

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

250 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

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

50 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

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

500 mg

Depotgranulat

Oral anvendelse

Frankrig

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

SANOFI AVENTIS FRANCE

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

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

750 mg

Depotgranulat

Oral anvendelse

Tyskland

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Tyskland |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Tyskland

CONVULEX 150

150 mg

Enterokapsel

Oral anvendelse

Tyskland

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Tyskland |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Tyskland

Convulex 300

300 mg

Enterokapsel

Oral anvendelse

Tyskland

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Tyskland |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Tyskland

Convulex 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Tyskland |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Tyskland

Convulex 500

500 mg

Enterokapsel

Oral anvendelse

Tyskland

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Tyskland |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Tyskland

Convulex 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Lundbeck GmbH |
| --- |
| Postfach 900662 |
| D-21046 Hamburg |
| Tyskland |

Lundbeck GmbH

Postfach 900662

D-21046 Hamburg

Tyskland

Convulex Tropflösung

300 mg

Oral opløsning

Oral anvendelse

Tyskland

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Tyskland

Convulsofin Tabletten

500 mg

tablet

Oral anvendelse

Tyskland

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

Steiner & Co.

Ostpreussendamm 72-74

D-12207 Berlin

Tyskland

Convulsofin-Tropfen

30 g

orale dråber, opløsning

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl 150 mg

150 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl 300 mg

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl 500 mg

500 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl chrono 300 mg

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl chrono 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Chronosphere 100 mg Retardgranulat

100 mg

Depotgranulat

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Chronosphere 1 000 mg Retardgranulat

1 000,6 mg

Depotgranulat

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Chronosphere 250 mg Retardgranulat

250 mg

Depotgranulat

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Chronosphere 50 mg Retardgranulat

50 mg

Depotgranulat

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Chronosphere 500 mg Retardgranulat

500,3 mg

Depotgranulat

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Chronosphere 750 mg Retardgranulat

750 mg

Depotgranulat

Oral anvendelse

Tyskland

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

D-65926 Frankfurt am Main

Tyskland

Ergenyl Lösung

300 mg

Oral opløsning

Oral anvendelse

Tyskland

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Tyskland |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Tyskland

espa-valept 150 mg

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Tyskland |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Tyskland

espa-valept 300 mg retard

300 mg

Depottabletter

Oral anvendelse

Tyskland

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Tyskland |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Tyskland

espa-valept 300 mg

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Tyskland |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Tyskland

espa-valept 500 mg retard

500 mg

Depottabletter

Oral anvendelse

Tyskland

| esparma GmbH |
| --- |
| Seepark 7 |
| D-39116 Magdeburg |
| Tyskland |

esparma GmbH

Seepark 7

D-39116 Magdeburg

Tyskland

espa-valept 600 mg

600 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Tyskland

Leptilan 150 mg

150 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Tyskland

Leptilan 300 mg

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Dolorgiet GmbH & Co.

Postfach 1252

D-53730 St.Augustin

Tyskland

Leptilan 600 mg

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Natriumvalproat Desitin retard 1 000 mg

1 000 mg

Depottabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Natriumvalproat Desitin retard 150 mg

150 mg

Depotkapsler

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Natriumvalproat Desitin retard 300 mg

300 mg

Depotkapsler

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Natriumvalproat Desitin retard 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril 150

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril 200 mg

200 mg

Enterotabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril 300

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril 500 mg

500 mg

Enterotabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril 600

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril long 1 000 mg

1 000 mg

Depottabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril long 150 mg

150 mg

Depotkapsler

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril long 300 mg

300 mg

Depotkapsler

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril long 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Orfiril Saft

60 mg

Oral opløsning

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valberg PR 300 mg

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valberg PR 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valdia PR 300 mg

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valdia PR 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valhel PR 300 mg

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valhel PR 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

| ALIUD PHARMA GmbH |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |
| Tyskland |

ALIUD PHARMA GmbH

Postfach 1380

D-89146 Laichingen

Tyskland

Valpro AL 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| ALIUD PHARMA GmbH |
| --- |
| Postfach 1380 |
| D-89146 Laichingen |
| Tyskland |

ALIUD PHARMA GmbH

Postfach 1380

D-89146 Laichingen

Tyskland

Valpro AL 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Tyskland |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Tyskland

Valpro beta

300 mg

Oral opløsning

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Tyskland |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Tyskland

Valpro beta 150

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Tyskland |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Tyskland

Valpro beta 300

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Tyskland |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Tyskland

Valpro beta 600

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Tyskland |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Tyskland

Valpro beta chrono 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| betapharm Arzneimittel GmbH |
| --- |
| Kobelweg 95 |
| D-86156 Augsburg |
| Tyskland |

betapharm Arzneimittel GmbH

Kobelweg 95

D-86156 Augsburg

Tyskland

Valpro beta chrono 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Tyskland |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Tyskland

Valpro TAD 150 mg

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Tyskland |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Tyskland

Valpro TAD 300 mg

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Tyskland |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Tyskland

Valpro TAD 600 mg

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Tyskland |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Tyskland

Valpro TAD chrono 300 mg

300 mg

Depottabletter

Oral anvendelse

Tyskland

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Tyskland |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Tyskland

Valpro TAD chrono 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

| TAD Pharma GmbH |
| --- |
| Postfach 720 |
| D-27457 Cuxhaven |
| Tyskland |

TAD Pharma GmbH

Postfach 720

D-27457 Cuxhaven

Tyskland

Valpro TAD Lösung

300 mg

Oral opløsning

Oral anvendelse

Tyskland

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

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Tyskland

Valproat AbZ 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

AbZ-Pharma GmbH

Dr. Georg-Spohn-Str. 7

D-89143 Blaubeuren

Tyskland

Valproat AbZ 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Tyskland

Valproat AWD 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

AWD.pharma GmbH & Co. KG

Wasastr. 50

D-01445 Radebeul

Tyskland

Valproat AWD 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Valproat chrono Desitin 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| Desitin Arzneimittel GmbH |
| --- |
| Postfach 630164 |
| D-22311 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Postfach 630164

D-22311 Hamburg

Tyskland

Valproat chrono Desitin 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Tyskland |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Tyskland

Valproat Chrono Winthrop 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Tyskland |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Tyskland

Valproat Chrono Winthrop 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Tyskland

Valproat chrono-CT 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Tyskland

Valproat chrono-CT 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Tyskland

Valproat Heumann chrono 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

Heumann Pharma GmbH & Co. Generica KG

Südwestpark 50

D-90449 Nürnberg

Tyskland

Valproat Heumann chrono 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Tyskland

Valproat HEXAL 150 mg Filmtabletten

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Tyskland

Valproat HEXAL 300 mg Filmtabletten

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Tyskland

Valproat HEXAL 300 mg/ml Lösung

300 mg

Oral opløsning

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Tyskland

Valproat HEXAL 600 mg Filmtabletten

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Tyskland

Valproat HEXAL chrono 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| D-83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

D-83602 Holzkirchen

Tyskland

Valproat HEXAL chrono 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

Orion Corporation

Postfach P.O. Box 65

FIN-02101 ESPOO

Finland

Valproat Orion 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

Orion Corporation

Postfach P.O. Box 65

FIN-02101 ESPOO

Finland

Valproat Orion 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Tyskland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Tyskland

Valproat Sandoz 150 mg magensaftresistente Filmtabletten

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Tyskland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Tyskland

Valproat Sandoz 300 mg magensaftresistente Filmtabletten

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Tyskland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Tyskland

Valproat Sandoz 600 mg magensaftresistente Filmtabletten

600 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Tyskland

Valproat STADA 300 mg retard

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

Stadapharm GmbH

Stadastr. 2-18

D-61118 Bad Vilbel

Tyskland

Valproat STADA 500 mg retard

500 mg

Depottabletter

Oral anvendelse

Tyskland

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Tyskland |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Tyskland

Valproat Win 300 mg Retardtabletten

200 mg

Depottabletter

Oral anvendelse

Tyskland

| Winthrop Arzneimittel GmbH |
| --- |
| Potsdamer Str. 8 |
| 10785 Berlin |
| Tyskland |

Winthrop Arzneimittel GmbH

Potsdamer Str. 8

10785 Berlin

Tyskland

Valproat Win 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Tyskland

Valproat-CT 150 mg Filmtabletten

150 mg

Enterotabletter

Oral anvendelse

Tyskland

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

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Tyskland

Valproat-CT 300 mg Filmtabletten

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

CT Arzneimittel GmbH

Lengeder Str. 42 a

D-13407 Berlin

Tyskland

Valproat-CT 600 mg Filmtabletten

600 mg

Enterotabletter

Oral anvendelse

Tyskland

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

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Tyskland

Valproat-neuraxpharm

300 mg

Oral opløsning

Oral anvendelse

Tyskland

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

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Tyskland

Valproat-neuraxpharm 150

150 mg

Enterotabletter

Oral anvendelse

Tyskland

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

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Tyskland

Valproat-neuraxpharm 300

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Tyskland

Valproat-neuraxpharm 600

600 mg

Enterotabletter

Oral anvendelse

Tyskland

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

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Tyskland

Valproat-neuraxpharm chrono 300 mg

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

neuraxpharm Arzneimittel GmbH u. Co.KG

Elisabeth-Selbert-Str. 23

D-40764 Langenfeld

Tyskland

Valproat-neuraxpharm chrono 500 mg

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Tyskland

Valproat-RPh 150 mg

150 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Tyskland

Valproat-RPh 300 mg

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Tyskland

Valproat-RPh 600 mg

600 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Dr. Lach Pharma Consulting

Bahnhofstr. 6

D-79359 Riegel

Tyskland

Valproat-RPh Lösung

300 mg

Oral opløsning

Oral anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Tyskland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Tyskland

Valproat-Sandoz 300 mg Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| D-83607 Holzkirchen |
| Tyskland |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

D-83607 Holzkirchen

Tyskland

Valproat-Sandoz 500 mg Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Tyskland

valprodura 150 mg

150 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Tyskland

valprodura 300 mg

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

Mylan dura GmbH

Postfach 10 06 35

D-64206 Darmstadt

Tyskland

valprodura 600 mg

600 mg

Enterotabletter

Oral anvendelse

Tyskland

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

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Tyskland

Valproinsäure Valeant 300

300 mg

Enterotabletter

Oral anvendelse

Tyskland

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

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Tyskland

Valproinsäure Valeant 300 Retard

300 mg

Depottabletter

Oral anvendelse

Tyskland

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

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Tyskland

Valproinsäure Valeant 500 Retard

500 mg

Depottabletter

Oral anvendelse

Tyskland

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

MEDA Pharma GmbH & Co. KG

Benzstrasse 1

61352 Bad Homburg

Tyskland

Valproinsäure Valeant 600

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Tyskland |

ratiopharm GmbH

D-89070 Ulm

Tyskland

Valproinsäure-ratiopharm 150

150 mg

Enterotabletter

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Tyskland |

ratiopharm GmbH

D-89070 Ulm

Tyskland

Valproinsäure-ratiopharm 300 Filmtabletten

300 mg

Enterotabletter

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Tyskland |

ratiopharm GmbH

D-89070 Ulm

Tyskland

Valproinsäure-ratiopharm 600

600 mg

Enterotabletter

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Tyskland |

ratiopharm GmbH

D-89070 Ulm

Tyskland

Valproinsäure-ratiopharm chrono 300 Retardtabletten

300 mg

Depottabletter

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Tyskland |

ratiopharm GmbH

D-89070 Ulm

Tyskland

Valproinsäure-ratiopharm chrono 500 Retardtabletten

500 mg

Depottabletter

Oral anvendelse

Tyskland

| ratiopharm GmbH |
| --- |
| D-89070 Ulm |
| Tyskland |

ratiopharm GmbH

D-89070 Ulm

Tyskland

Valproinsäure-ratiopharm Lösung

300 mg

Oral opløsning

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valsil PR 300 mg

199,8 mg

Depottabletter

Oral anvendelse

Tyskland

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

IIP-Institut für industrielle Pharmazie

Benzstr. 2 a

D-63741 Aschaffenburg

Tyskland

Valsil PR 500 mg

333 mg

Depottabletter

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674, Athens

Grækenland

DEPAKINE CHRONO

500 MG/TAB

Depottabletter

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO

300 MG/TAB

Depottabletter

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO (SPHERE)

50 MG/SACHET

Granulat med modificeret udløsning

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO (SPHERE)

100 MG/SACHET

Granulat med modificeret udløsning

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO (SPHERE)

250 MG/SACHET

Granulat med modificeret udløsning

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO (SPHERE)

500 MG/SACHET

Granulat med modificeret udløsning

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO (SPHERE)

750 MG/SACHET

Granulat med modificeret udløsning

Oral anvendelse

Grækenland

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

SANOFI-AVENTIS AEBE

348 Syggrou Avenue, Building A’

Kallithea 17674

Athens

Grækenland

DEPAKINE CHRONO (SPHERE)

1 000 MG/SACHET

Granulat med modificeret udløsning

Oral anvendelse

Ungarn

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

Orion Corporation

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

Finland

ABSENOR

300 mg

Tabletter med modificeret udløsning

Oral anvendelse

Ungarn

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

Orion Corporation

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

Finland

ABSENOR

500 mg

Tabletter med modificeret udløsning

Oral anvendelse

Ungarn

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

150 mg

Kapsel, hård

Oral anvendelse

Ungarn

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

300 mg

Kapsel, hård

Oral anvendelse

Ungarn

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

300 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

500 mg

Kapsel, hård

Oral anvendelse

Ungarn

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

500 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

| Gerot Pharmazeutica GmbH |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutica GmbH

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

43,38 mg/1 ml

syrup

Oral anvendelse

Ungarn

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

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Ungarn

DEPAKINE CHRONO

300 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

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

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Ungarn

DEPAKINE CHRONO

500 mg

Filmovertrukken tablet

Oral anvendelse

Ungarn

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

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Ungarn

DEPAKINE CHRONOSPHERE

50 mg

(14,51 mg/33,33 mg)

Granulat med modificeret udløsning

Oral anvendelse

Ungarn

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

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Ungarn

DEPAKINE CHRONOSPHERE

100 mg

(29,03 mg/66,66 mg)

Granulat med modificeret udløsning

Oral anvendelse

Ungarn

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

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Ungarn

DEPAKINE CHRONOSPHERE

250 mg

(72,61 mg/166,76 mg)

Granulat med modificeret udløsning

Oral anvendelse

Ungarn

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

Sanofi-aventis

Tó u. 1-5

HU-1045 Budapest

Ungarn

DEPAKINE

7,50g/150 ml

syrup

Oral anvendelse

Ungarn

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Tyskland

ORFIRIL

300 mg

Enterotabletter

Oral anvendelse

Ungarn

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Tyskland

ORFIRIL

300 mg

Overtrukne tabletter

Oral anvendelse

Ungarn

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

Desitin Arzneimittel GmbH

Weg beim Jäger 214

D-22335, Hamburg

Tyskland

ORFIRIL

600 mg

Overtrukne tabletter

Oral anvendelse

Island

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

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

Norge

Depakine

200 mg/ml

Oral opløsning

Oral anvendelse

Island

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

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

Norge

Depakine

200 mg

Enterotabletter

Oral anvendelse

Island

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

Sanofi-aventis Norge A/S

Strandveien 15

1325 Lysaker

Norge

Depakine

500 mg

Enterotabletter

Oral anvendelse

Island

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

60 mg/ml

Oral opløsning

Oral anvendelse

Island

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

150 mg

Enterotabletter

Oral anvendelse

Island

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

300 mg

Enterotabletter

Oral anvendelse

Island

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

600 mg

Enterotabletter

Oral anvendelse

Island

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril Retard

300 mg

tablet

Oral anvendelse

Italien

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

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma Italien

ORFILEPT

300 mg

Depotkapsler, hård

Oral anvendelse

Italien

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

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma Italien

ORFILEPT

500 mg

Depotgranulat

Oral anvendelse

Italien

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

Biofutura Pharma S.p.A.

Via Pontina Km 30,400 00040

Pomezia - Roma Italien

ORFILEPT

1 000 mg

Depotgranulat

Oral anvendelse

Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italien

NAVALAC

300 mg

Depottabletter

Oral anvendelse

Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italien

NAVALAC

500 mg

Depottabletter

Oral anvendelse

Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italien

TOVAPROX

300 mg

Depottabletter

Oral anvendelse

Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italien

TOVAPROX

500 mg

Depottabletter

Oral anvendelse

Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italien

ACIDO VALPROICO SANDOZ

300 mg

Depottabletter

Oral anvendelse

Italien

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

Sandoz S.p.A.

Largo Boccioni, 1

21040 Origgio (VA)

Italien

ACIDO VALPROICO SANDOZ

500 mg

Depottabletter

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

200 mg

Enterotabletter

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

500 mg

Enterotabletter

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

200 mg/ml

Oral opløsning

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN CHRONO

300 mg

Depottabletter

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN CHRONO

500 mg

Depottabletter

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Italien

| 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

Granulat med modificeret udløsning

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

50 mg

Granulat med modificeret udløsning

Oral anvendelse

Italien

| Sanofi-Aventis France S.A. |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France S.A.

1-13, boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKIN

750 mg

Granulat med modificeret udløsning

Oral anvendelse

Italien

| Sanofi-Aventis spa |
| --- |
| Viale Luigi/Bodio, 37B |
| 20158 Milano |

Sanofi-Aventis spa

Viale Luigi/Bodio, 37B

20158 Milano

DEPAMIDE

300 mg

Enterotabletter

Oral anvendelse

Italien

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italien |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

Italien

DEPAMAG

200 mg

Enterotabletter

Oral anvendelse

Italien

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italien |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

Italien

DEPAMAG

500 mg

Enterotabletter

Oral anvendelse

Italien

| Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. |
| --- |
| Viale Shakespeare, 47 |
| 00144 Roma |
| Italien |

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.

Viale Shakespeare, 47

00144 Roma

Italien

DEPAMAG

100 mg/ml

Oral opløsning

Oral anvendelse

Italien

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Tyskland |

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Tyskland

ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM

300 mg

Depottabletter

Oral anvendelse

Italien

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Tyskland |

Ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Tyskland

ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM

500 mg

Depottabletter

Oral anvendelse

Italien

| EG Laboratori EuroGenerici S.P.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italien |

EG Laboratori EuroGenerici S.P.A.

Via Pavia, 6

20136 Milano

Italien

ACIDO VALPROICO E SODIO VALPROATO EG

300 mg

Depottabletter

Oral anvendelse

Italien

| EG Laboratori EuroGenerici S.P.A. |
| --- |
| Via Pavia, 6 |
| 20136 Milano |
| Italien |

EG Laboratori EuroGenerici S.P.A.

Via Pavia, 6

20136 Milano

Italien

ACIDO VALPROICO E SODIO VALPROATO EG

500 mg

Depottabletter

Oral anvendelse

Italien

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italien |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italien

SODIO VALPROATO WINTHROP

500 mg

Enterotabletter

Oral anvendelse

Italien

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italien |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italien

SODIO VALPROATO WINTHROP

200 mg/ml

Oral opløsning

Oral anvendelse

Italien

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italien |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italien

SODIO VALPROATO WINTHROP

300 mg

Depottabletter

Oral anvendelse

Italien

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italien |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italien

SODIO VALPROATO WINTHROP

500 mg

Depottabletter

Oral anvendelse

Italien

| Winthrop Pharmaceuticals Italia S.r.l. |
| --- |
| Viale Luigi Bodio, 37b |
| 20158 Milano |
| Italien |

Winthrop Pharmaceuticals Italia S.r.l.

Viale Luigi Bodio, 37b

20158 Milano

Italien

SODIO VALPROATO WINTHROP

200 mg

Enterotabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epi-Chrono

PA 540/149/1

200 mg

Depottabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epi-Chrono

PA 540/149/2

300 mg

Depottabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epi-Chrono

PA 540/149/3

500 mg

Depottabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Crushable

PA 540/150/1

100 mg

tablet

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Enteric

PA 540/150/2

200 mg

Overtrukne Enterotabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Enteric

PA 540/150/3

500 mg

Overtrukne Enterotabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chronosphere

PA 540/150/4

50 mg

Depotgranulat

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chronosphere

PA 540/150/5

100 mg

Depotgranulat

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chronosphere

PA 540/150/6

250 mg

Depotgranulat

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chronosphere

PA 540/150/7

500 mg

Depotgranulat

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chronosphere

PA 540/150/8

750 mg

Depotgranulat

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chronosphere

PA 540/150/9

1 000 mg

Depotgranulat

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chrono

PA 540/150/10

200 mg

Depottabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chrono

PA 540/150/11

300 mg

Depottabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Chrono

PA 540/150/12

500 mg

Depottabletter

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Intravenous

PA 540/150/13

400 mg

Pulver og solvens til infusion, opløsning

Intravenøs anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Liquid

PA 540/150/14

200 mg/5ml

Oral opløsning

Oral anvendelse

Irland

| Sanofi-aventis Ireland Limited |
| --- |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Sanofi-aventis Ireland Limited

Citywest Business Campus

Dublin 24

Irland

Epilim Syrup

PA 540/150/15

200 mg/5ml

syrup

Oral anvendelse

Letland

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz 300 mg gastro-resistant capsules, soft

300 mg

Depottabletter

Oral anvendelse

Letland

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz 500 mg Prolonged release tablets

500 mg

Depottabletter

Oral anvendelse

Letland

| Stada Arzneimittel AG |
| --- |
| Stadastraße 2-18 |
| D-61118 Bad Vilbel |
| Tyskland |

Stada Arzneimittel AG

Stadastraße 2-18

D-61118 Bad Vilbel

Tyskland

Convulex 150 mg gastro-resistant capsules, soft

150 mg

Enterokapsler, bløde

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex 300 mg gastro-resistant capsules, soft

300 mg

Enterokapsler, bløde

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex 500 mg gastro-resistant capsules, soft

500 mg

Enterokapsler, bløde

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex 500 mg gastro-resistant capsules, soft

500 mg

Enterokapsler, bløde

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex retard 300 mg prolonged release tablets

300 mg

Depottabletter

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex retard 500 mg prolonged release tablets

500 mg

Depottabletter

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex 50 mg/ ml syrup

50 mg/ml

syrup

Oral anvendelse

Letland

| Gerot Pharmazeutika Ges.m.b.H |
| --- |
| Arnethgasse 3 |
| AT-1160 Wien |
| ØSTRIG |

Gerot Pharmazeutika Ges.m.b.H

Arnethgasse 3

AT-1160 Wien

ØSTRIG

Convulex 300 mg/ml Oral solution

300 mg/ml

Oral opløsning

Oral anvendelse

Letland

| Sanofi-aventis Letland SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Letland |

Sanofi-aventis Letland SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Letland

Depakine Chrono 300 mg prolonged release tablets

300 mg

Depottabletter

Oral anvendelse

Letland

| Sanofi-aventis Letland SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Letland |

Sanofi-aventis Letland SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Letland

Depakine Chrono 500 mg prolonged release tablets

500 mg

Depottabletter

Oral anvendelse

Letland

| Sanofi-aventis Letland SIA |
| --- |
| Kr. Valdemāra iela 33 - 8 |
| LV - 1010 Riga |
| Letland |

Sanofi-aventis Letland SIA

Kr. Valdemāra iela 33 - 8

LV - 1010 Riga

Letland

Depakine 57,64 mg/ml syrup

57,64 mg/ml

syrup

Oral anvendelse

Letland

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI - 02200 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

FI - 02200 Espoo

FINLAND

Absenor 500 mg prolonged release tablets

500 mg

Depottabletter

Oral anvendelse

Letland

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI - 02200 Espoo |
| FINLAND |

Orion Corporation

Orionintie 1

FI - 02200 Espoo

FINLAND

Absenor 300 mg prolonged release tablets

300 mg

Depottabletter

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex retard

500 mg

Depottabletter

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex retard

300 mg

Depottabletter

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex

50 mg/ml

syrup

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex

300 mg/ml

Oral opløsning

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex

150 mg

Enterokapsler, bløde

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex

300 mg

Enterokapsler, bløde

Oral anvendelse

Litauen

| Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 |
| --- |
| A-1160 Vienna |
| Østrig |

Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3

A-1160 Vienna

Østrig

Convulex

500 mg

Enterokapsler, bløde

Oral anvendelse

Litauen

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor

500 mg

Depottabletter

Oral anvendelse

Litauen

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Absenor

300 mg

Depottabletter

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine

57,64 mg/ml

syrup

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

50 mg

Granulat med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

750 mg

Granulat med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chrono

500 mg

Tabletter med modificeret udløsning

Oral anvendelse

Litauen

| UAB »Sanofi Aventis« Lietuva |
| --- |
| A. Juozapaviciaus 6/2 |
| LT-09310 Vilnius |
| Litauen |

UAB »Sanofi Aventis« Lietuva

A. Juozapaviciaus 6/2

LT-09310 Vilnius

Litauen

Depakine Chronosphere

300 mg

Tabletter med modificeret udløsning

Oral anvendelse

Litauen

| Stada Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Tyskland |

Stada Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Tyskland

Prodepa

500 mg

Depottabletter

Oral anvendelse

Litauen

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz

300 mg

Depottabletter

Oral anvendelse

Litauen

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenia |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenia

Valproate sodium Sandoz

500 mg

Depottabletter

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE

30 %

solution

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE

6 %

syrup

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE CHRONO

300 mg

tablet

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE CHRONO

500 mg

tablet

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE ENTERIC

150 mg

tablet

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE ENTERIC

300 mg

tablet

Oral anvendelse

Luxembourg

| Sanofi-Aventis Belgium |
| --- |
| Culliganlaan 1C |
| B-1831 Diegem |
| Belgien |

Sanofi-Aventis Belgium

Culliganlaan 1C

B-1831 Diegem

Belgien

DEPAKINE ENTERIC

500 mg

tablet

Oral anvendelse

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

300 mg

Depottabletter

Oral anvendelse

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

500 mg

Depottabletter

Oral anvendelse

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

250 mg/5ml

syrup

Oral anvendelse

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

300 mg

Kapsler

Oral anvendelse

Luxembourg

| Gerot Pharmazeutika GmbH Arnethgasse 3 |
| --- |
| A-1160 Wien |
| Østrig |

Gerot Pharmazeutika GmbH Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX

500 mg

Kapsler

Oral anvendelse

Luxembourg

| Ratiopharm GmbH Arzneimittel Postfach 3380 |
| --- |
| D-89070 Ulm |
| Tyskland |

Ratiopharm GmbH Arzneimittel Postfach 3380

D-89070 Ulm

Tyskland

Valproinsäure-Ratiopharm

300 mg

Depottabletter

Oral anvendelse

Luxembourg

| Ratiopharm GmbH Arzneimittel Postfach 3380 |
| --- |
| D-89070 Ulm |
| Tyskland |

Ratiopharm GmbH Arzneimittel Postfach 3380

D-89070 Ulm

Tyskland

Valproinsäure-Ratiopharm

500 mg

Depottabletter

Oral anvendelse

Luxembourg

| Hexal AG |
| --- |
| Industriestrasse 25 |
| D-83607 Holzkirchen |
| Tyskland |

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Tyskland

Valproat-Hexal Chrono

300 mg

tablet

Oral anvendelse

Luxembourg

| Hexal AG |
| --- |
| Industriestrasse 25 |
| D-83607 Holzkirchen |
| Tyskland |

Hexal AG

Industriestrasse 25

D-83607 Holzkirchen

Tyskland

Valproat-Hexal Chrono

500 mg

tablet

Oral anvendelse

Luxembourg

| Eurogenerics s.a. |
| --- |
| Esplanade Heysel B.22 |
| B-1020 Bruxelles |
| Belgien |

Eurogenerics s.a.

Esplanade Heysel B.22

B-1020 Bruxelles

Belgien

Valproate Retard-EG

300 mg

Depottabletter

Oral anvendelse

Luxembourg

| Eurogenerics s.a. |
| --- |
| Esplanade Heysel |
| B.22 B-1020 Bruxelles |
| Belgien |

Eurogenerics s.a.

Esplanade Heysel

B.22 B-1020 Bruxelles

Belgien

Valproate Retard-EG

500 mg

Depottabletter

Oral anvendelse

Malta

| Norton Healthcare Limited |
| --- |
| Ivax Pharmaceuticals |
| Ivax Quays |
| Albert Basin, Royal Docks |
| London E16 2QJ |
| England |

Norton Healthcare Limited

Ivax Pharmaceuticals

Ivax Quays

Albert Basin, Royal Docks

London E16 2QJ

England

Sodium valproate Oral opløsning BP

200 mg/5ml

Oral opløsning

Oral anvendelse

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/5ml

Oral opløsning

Oral anvendelse

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

Depottabletter

Oral anvendelse

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

Depottabletter

Oral anvendelse

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

Depottabletter

Oral anvendelse

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

Granulat med modificeret udløsning

Oral anvendelse

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

Granulat med modificeret udløsning

Oral anvendelse

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

Granulat med modificeret udløsning

Oral anvendelse

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

Granulat med modificeret udløsning

Oral anvendelse

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

Granulat med modificeret udløsning

Oral anvendelse

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

Granulat med modificeret udløsning

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril Long

500 mg

Depotgranulat

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril Long

1 000 mg

Depotgranulat

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril Long

150 mg

Depotkapsler

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril Long

300 mg

Depotkapsler

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril Retard

300 mg

Depottabletter

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

150 mg

Enterotabletter

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

300 mg

Enterotabletter

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

600 mg

Enterotabletter

Oral anvendelse

Norge

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norge |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norge

Deprakine

100 mg

Enterotabletter

Oral anvendelse

Norge

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norge |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norge

Deprakine

300 mg

Enterotabletter

Oral anvendelse

Norge

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norge |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norge

Deprakine

500 mg

Enterotabletter

Oral anvendelse

Norge

| Destin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Destin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril

60 mg/mL

Oral opløsning

Oral anvendelse

Norge

| Sanofi-Aventis Norge AS |
| --- |
| PB 133 |
| 1325 Lysaker |
| Norge |

Sanofi-Aventis Norge AS

PB 133

1325 Lysaker

Norge

Deprakine

60 mg/mL

Oral opløsning

Oral anvendelse

Polen

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Østrig |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Østrig

Convulex 150

150 mg

kapsel, blød

Oral anvendelse

Polen

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Østrig |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Østrig

Convulex 300

300 mg

kapsel, blød

Oral anvendelse

Polen

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Østrig |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Østrig

Convulex

500 mg

kapsel, blød

Oral anvendelse

Polen

| G.L. Pharma GmbH |
| --- |
| Schloβplatz 1 |
| A-8502 Lannach |
| Østrig |

G.L. Pharma GmbH

Schloβplatz 1

A-8502 Lannach

Østrig

Convulex

50 mg/ml

syrup

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril

300 mg/5 ml (60 mg/ml)

Oral opløsning

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril 150

150 mg

Enterotabletter

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril 300

300 mg

Enterotabletter

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril 600

600 mg

Enterotabletter

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril 300 retard

300 mg

Depot Enterotabletter

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril Long 150

150 mg

Depotkapsler

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril Long 300

300 mg

Depotkapsler

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril Long 500

500 mg

mini-depottablet

Oral anvendelse

Polen

| Desitin Arznemittel GmbH |
| --- |
| Weg beim Jager 214 |
| Hamburg 22335 |
| Tyskland |

Desitin Arznemittel GmbH

Weg beim Jager 214

Hamburg 22335

Tyskland

Orfiril Long 1 000

1 000 mg

mini-depottablet

Oral anvendelse

Polen

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Tyskland |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Tyskland

Valproic Acid ER-APC 300

300 mg

Depottabletter

Oral anvendelse

Polen

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm89079 |
| Tyskland |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm89079

Tyskland

Valproic Acid ER-APC 500

500 mg

Depottabletter

Oral anvendelse

Polen

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Tyskland |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Tyskland

Valpro-ratiopharm Chrono 300 mg

199,8 mg + 87 mg

Depottabletter

Oral anvendelse

Polen

| ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| Ulm 89079 |
| Tyskland |

ratiopharm GmbH

Graf-Arco-Strasse 3

Ulm 89079

Tyskland

Valpro-ratiopharm Chrono 500 mg

333 mg + 145 mg

Depottabletter

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| Warsaw 00-203 |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

Warsaw 00-203

Polen

Depakine Chrono 300

200 mg + 87 mg

Filmovertrukken depottablet

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Polen

Depakine Chrono 500

333 mg + 145 mg

Filmovertrukken depottablet

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Polen

Depakine Chronosphere 100

66,66 mg + 29,03 mg

Depotgranulat

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Polen

Depakine Chronosphere 250

166,76 mg + 72,61 mg

Depotgranulat

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Polen

Depakine Chronosphere 500

333,30 mg + 145,14 mg

Depotgranulat

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Polen

Depakine Chronosphere 750

500,06 mg + 217,75 mg

Depotgranulat

Oral anvendelse

Polen

| Sanofi-Aventis Sp. z o.o. |
| --- |
| ul. Bonifraterska 17 |
| 00.-203 Warsaw |
| Polen |

Sanofi-Aventis Sp. z o.o.

ul. Bonifraterska 17

00.-203 Warsaw

Polen

Depakine Chronosphere 1 000

666,60 mg + 290,27 mg

Depotgranulat

Oral anvendelse

Polen

| Sanofi-Aventis France |
| --- |
| 1-13 bld Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France

1-13 bld Romain Rolland

75014 Paris

Frankrig

Depakine

288,2 mg/5 ml

syrup

Oral anvendelse

Polen

| Sanofi-Aventis France |
| --- |
| 1-13 bld Romain Rolland |
| 75014 Paris |
| Frankrig |

Sanofi-Aventis France

1-13 bld Romain Rolland

75014 Paris

Frankrig

Depakine 200

200 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| ICN Polfa Rzeszów S.A. |
| --- |
| Przemysłowa 2 st. |
| Rzeszów 35-959 |
| Polen |

ICN Polfa Rzeszów S.A.

Przemysłowa 2 st.

Rzeszów 35-959

Polen

Dipromal

200 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| Kundl 6250 |
| Østrig |

Sandoz GmbH

Biochemiestrasse 10

Kundl 6250

Østrig

ValproLEK 300

300 mg

Depottabletter

Oral anvendelse

Polen

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| Kundl 6250 |
| Østrig |

Sandoz GmbH

Biochemiestrasse 10

Kundl 6250

Østrig

ValproLEK 500

500 mg

Depottabletter

Oral anvendelse

Polen

| Orion Corporation |
| --- |
| Orionintie 1 |
| Espoo 02200 |
| Finland |

Orion Corporation

Orionintie 1

Espoo 02200

Finland

Absenor

300 mg

Tabletter med modificeret udløsning

Oral anvendelse

Polen

| Orion Corporation |
| --- |
| Orionintie 1 |
| Espoo 02200 |
| Finland |

Orion Corporation

Orionintie 1

Espoo 02200

Finland

Absenor

500 mg

Tabletter med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine

200 mg/ml

Oral opløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chrono 300

300 mg

Depottabletter

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park |
| Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park

Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chrono 500

500 mg

Depottabletter

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil

200 mg

Overtrukne tabletter

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil

500 mg

Enterotabletter

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil

200 mg/ml

Oral opløsning

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil-R

250 mg

Overtrukne tabletter

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil-R

500 mg

Overtrukne tabletter

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine

40 mg/ml

syrup

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 150

150 mg

Depotkapsler

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 300

300 mg

Depotkapsler

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 500

500 mg

Depotgranulat

Oral anvendelse

Portugal

| Tecnifar - Indústria Técnica Farmacêutica S.A. |
| --- |
| Rua Tierno Galvan - Amoreiras - Torre 3 - 12o |
| 1099-036 Lisboa |
| Portugal |

Tecnifar - Indústria Técnica Farmacêutica S.A.

Rua Tierno Galvan - Amoreiras - Torre 3 - 12o

1099-036 Lisboa

Portugal

Diplexil 1 000

1 000 mg

Depotgranulat

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 50/350

50 - 350 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 500/1 000

500 - 1000 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 50 mg

50 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 100 mg

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 250 mg

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 500 mg

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 750 mg

750 mg

Granulat med modificeret udløsning

Oral anvendelse

Portugal

| Sanofi-Aventis - Produtos Farmacêuticos S.A. |
| --- |
| Empreendimento Lagoas Park, Edifício 7 - 3o |
| 2740-299 Porto Salvo |
| Portugal |

Sanofi-Aventis - Produtos Farmacêuticos S.A.

Empreendimento Lagoas Park, Edifício 7 - 3o

2740-299 Porto Salvo

Portugal

Depakine Chronosphere 1 000 mg

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

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

Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada

300 mg

Depottabletter

Oral anvendelse

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

Ácido Valpróico Generis

500 mg

Depottabletter

Oral anvendelse

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

Ácido Valpróico Generis

300 mg

Depottabletter

Oral anvendelse

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

Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada

500 mg

Depottabletter

Oral anvendelse

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada

300 mg

Depottabletter

Oral anvendelse

Portugal

| Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda. |
| --- |
| Rua Quinta do Pinheiro |
| Edifício Tejo - 6o Piso |
| 2790-143 Carnaxide |
| Portugal |

Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.

Rua Quinta do Pinheiro

Edifício Tejo - 6o Piso

2790-143 Carnaxide

Portugal

Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada

500 mg

Depottabletter

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONOSPHERE 100 mg

29,03 mg/66,66 mg

Depotgranulat

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONOSPHERE 250 mg

72,61 mg/166,76 mg

Depotgranulat

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONOSPHERE 500 mg

145,14 mg/333,3 mg

Depotgranulat

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONOSPHERE 750 mg

217,75 mg/500,06 mg

Depotgranulat

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONOSPHERE 1 000 mg

290,27 mg/666,60 mg

Depotgranulat

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE

57,64 mg/ml

syrup

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONO 300 mg

87 mg/199,8 mg

Depottablet

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE CHRONO 500 mg

145 mg/333 mg

Depottablet

Oral anvendelse

Romænien

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

SANOFI AVENTIS FRANCE

1-13 boulevard Romain Rolland

75014 Paris

Frankrig

DEPAKINE 200 mg

200 mg

Enterotablet

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL 150

150 mg

Enterotablet

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL 300

300 mg

Enterotablet

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL 600

600 mg

Enterotablet

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG 150 mg

150 mg

Depotkapsler

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG 300 mg

300 mg

Depotkapsler

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG 500 mg

500 mg

Depotgranulat

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL LONG 1 000 mg

1 000 mg

Depotgranulat

Oral anvendelse

Romænien

| DESITIN ARZNEIMITTEL GmbH |
| --- |
| Weg Beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

DESITIN ARZNEIMITTEL GmbH

Weg Beim Jäger 214

22335 Hamburg

Tyskland

ORFIRIL SIROP

300 mg/5 ml

syrup

Oral anvendelse

Romænien

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 150 mg

150 mg

Enterokapsler, bløde

Oral anvendelse

Romænien

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 300 mg

300 mg

Enterokapsler, bløde

Oral anvendelse

Romænien

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 500 mg

500 mg

Enterokapsler, bløde

Oral anvendelse

Romænien

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX RETARD 300 mg

300 mg

Depottabletter

Oral anvendelse

Romænien

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX RETARD 500 mg

500 mg

Depottabletter

Oral anvendelse

Romænien

| GEROT PHARMAZEUTIKA Ges.m.b.H. |
| --- |
| Arnethgasse 3 |
| A-1160 Wien |
| Østrig |

GEROT PHARMAZEUTIKA Ges.m.b.H.

Arnethgasse 3

A-1160 Wien

Østrig

CONVULEX 50 mg/ml

50 mg/ml

syrup

Oral anvendelse

Romænien

| REMEDICA Ltd. |
| --- |
| Limassol Industrial Estate |
| Aharnon P.O Box 51706 |
| 3508 Limassol |
| Cypern |

REMEDICA Ltd.

Limassol Industrial Estate

Aharnon P.O Box 51706

3508 Limassol

Cypern

PETILIN 200

200 mg

Filmovertrukken tablet

Oral anvendelse

Romænien

| S.C. ARENA GROUP S.A. |
| --- |
| Str. Ștefan Mihăileanu nr. 31 |
| Sector 2, București |
| România |

S.C. ARENA GROUP S.A.

Str. Ștefan Mihăileanu nr. 31

Sector 2, București

România

VALEPIL

200 mg/5 ml

syrup

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Propymal Enteric 150 mg

150 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Propymal Enteric 300 mg

300 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Propymal Enteric 450 mg

450 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Propymal Enteric 600 mg

600 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Zuur

125 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Zuur

250 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Zuur

500 mg

Enterokapsler, bløde

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine

300 mg

tablet

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine

300 mg/ml

orale dråber, opløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Retard

300 mg

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Enteric

150 mg

Enterotabletter

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Enteric

300 mg

Enterotabletter

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Enteric

500 mg

Enterotabletter

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine vloeistof voor kinderen

300 mg/ml

Oral opløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine suikervrije stroop

40 mg/ml

syrup

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Natriumvalproaat Enteric Winthrop 150 mg

150 mg

Enterotabletter

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Natriumvalproaat Enteric Winthrop 300 mg

300 mg

Enterotabletter

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Natriumvalproaat Enteric Winthrop 500 mg

500 mg

Enterotabletter

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Natrii Valproas

300 mg

Enterotabletter

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Natriumvalproaat Apotex 150 mg

150 mg

Enterotabletter

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Natriumvalproaat Apotex 300 mg

300 mg

Enterotabletter

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Natriumvalproaat Apotex 600 mg

600 mg

Enterotabletter

Oral anvendelse

Holland

| Apotex Europe B.V. |
| --- |
| Darwinweg 20 |
| 2333 CR Leiden |
| Holland |

Apotex Europe B.V.

Darwinweg 20

2333 CR Leiden

Holland

Natriumvalproaat Apotex 300 mg/5 ml

60 mg/ml

Oral opløsning

Oral anvendelse

Holland

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| Holland |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

Holland

Orfiril CR 150 mg

150 mg

modified-release Kapsler

Oral anvendelse

Holland

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| Holland |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

Holland

Orfiril CR 300 mg

300 mg

modified-release Kapsler

Oral anvendelse

Holland

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| Holland |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

Holland

Orfiril CR 500 mg

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Holland

| Pharmachemie BV |
| --- |
| Swensweg 5 |
| NL-2003 RN Haarlem |
| Holland |

Pharmachemie BV

Swensweg 5

NL-2003 RN Haarlem

Holland

Orfiril CR 1 000 mg

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Holland

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam |
| Holland |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam

Holland

Natriumvalproaat ratiopharm chrono 300 mg

300 mg

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| Ratiopharm Nederland B.V. |
| --- |
| Ronde Tocht 11 |
| NL-1507 CC Zaandam |
| Holland |

Ratiopharm Nederland B.V.

Ronde Tocht 11

NL-1507 CC Zaandam

Holland

Natriumvalproaat ratiopharm chrono 500 mg

500 mg

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chrono 300

200 mg sodium valproate and 87 mg valproic acid

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chrono 500

333 mg sodium valproate and 145 mg valproic acid

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Natriumvalproaat Chrono Winthrop 300 mg

200 mg sodium valproate and 87 mg valproic acid

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Natriumvalproaat Chrono Winthrop 500 mg

333 mg sodium valproate and 145 mg valproic acid

Tabletter med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere

220 mg sodium valproate and 95,8 mg valproic acid per gram

Granulat med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere 50 mg

33,33 sodium valproate and 14,51 mg valproic acid per sachet

Granulat med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere 100 mg

66,66 sodium valproate and 29,03 mg valproic acid per sachet

Granulat med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere 250 mg

166,76 sodium valproate and 72,61 mg valproic acid per sachet

Granulat med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere 500 mg

333,30 sodium valproate and 145,14 mg valproic acid per sachet

Granulat med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere 750 mg

500,06 sodium valproate and 217,75 mg valproic acid per sachet

Granulat med modificeret udløsning

Oral anvendelse

Holland

| sanofi-aventis Netherlands B.V. |
| --- |
| Kampenringweg 45 D-E |
| NL-2803 PE Gouda |
| Holland |

sanofi-aventis Netherlands B.V.

Kampenringweg 45 D-E

NL-2803 PE Gouda

Holland

Depakine Chronosphere 1 000 mg

666,60 sodium valproate and 290,27 mg valproic acid per sachet

Granulat med modificeret udløsning

Oral anvendelse

Holland

| Ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| Holland |

Ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

Holland

Natriumvalproaat ratiopharm chrono 300 mg

200 mg sodium valproate and 87 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Ratiopharm Nederland B.V. |
| --- |
| Florapark 4 |
| 2012 HK Haarlem |
| Holland |

Ratiopharm Nederland B.V.

Florapark 4

2012 HK Haarlem

Holland

Natriumvalproaat ratiopharm chrono 500 mg

333 mg sodium valproate and 145 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| 4879 AC Etten-Leur |
| Holland |

Centrafarm Services BV

Nieuwe Donk 9

4879 AC Etten-Leur

Holland

Natriumvalproaat Chrono CF 300 mg

200 mg sodium valproate and 87 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Centrafarm Services BV |
| --- |
| Nieuwe Donk 9 |
| 4879 AC Etten-Leur |
| Holland |

Centrafarm Services BV

Nieuwe Donk 9

4879 AC Etten-Leur

Holland

Natriumvalproaat Chrono CF 500 mg

333 mg sodium valproate and 145 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| Holland |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

Holland

Natriumvalproaat Chrono Sandoz 300 mg

200 mg sodium valproate and 87 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| Holland |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

Holland

Natriumvalproaat Chrono Sandoz 500 mg

333 mg sodium valproate and 145 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| Holland |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

Holland

Natriumvalproaat Sandoz Chrono 300

200 mg sodium valproate and 87 mg valproic acid

Depottabletter

Oral anvendelse

Holland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| NL-1327 AH Almere |
| Holland |

Sandoz B.V.

Veluwezoom 22

NL-1327 AH Almere

Holland

Natriumvalproaat Sandoz Chrono 500

333 mg sodium valproate and 145 mg valproic acid

Depottabletter

Oral anvendelse

Slovakiet

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintrie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintrie 1

02200 Espoo

Finland

Absenor 300 mg tablety s predĺženým uvoľňovaním

300 mg

Depottabletter

Oral anvendelse

Slovakiet

| Orion Corporation |
| --- |
| Orion Pharma |
| Orionintrie 1 |
| 02200 Espoo |
| Finland |

Orion Corporation

Orion Pharma

Orionintrie 1

02200 Espoo

Finland

Absenor 500 mg tablety s predĺženým uvoľňovaním

500 mg

Depottabletter

Oral anvendelse

Slovakiet

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

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Østrig

Convulex 150 mg kapsuly

150 mg

Kapsler

Oral anvendelse

Slovakiet

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

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Østrig

Convulex 300 mg kapsuly

300 mg

Kapsler

Oral anvendelse

Slovakiet

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

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Østrig

Convulex 500 mg kapsuly

500 mg

Kapsler

Oral anvendelse

Slovakiet

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

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Østrig

CONVULEX

50 mg/ml

syrup

Oral anvendelse

Slovakiet

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

G.L. Pharma GmbH Schlossplatz 1

8502 Lannach

Østrig

Convulex 300 mg/ml kvapky

300 mg/ml

Orale dråber

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

DEPAKINE

100 mg/ml

syrup

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

DEPAKINE CHRONO 500 mg

500 mg

Filmovertrukne Depottabletter

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

Depakine Chronosphere 50 mg

50 mg

Granulat med modificeret udløsning

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

Depakine Chronosphere 100 mg

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

Depakine Chronosphere 250 mg

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

Depakine Chronosphere 500 mg

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

Depakine Chronosphere 750 mg

750 mg

Granulat med modificeret udløsning

Oral anvendelse

Slovakiet

| Sanofi-aventis Slovakia, s.r.o., |
| --- |
| Žilinská 7-9 |
| 811 05 Bratislava |
| Slovenien |

Sanofi-aventis Slovakia, s.r.o.,

Žilinská 7-9

811 05 Bratislava

Slovenien

Depakine Chronosphere 1 000 mg

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril 150

150 mg

Enterotabletter

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril 300

300 mg

Enterotabletter

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril 600

600 mg

Enterotabletter

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril long 150 mg

150 mg

Depotkapsler

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril long 300 mg

300 mg

Depotkapsler

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril long 500 mg

500 mg

Depottabletter

Oral anvendelse

Slovakiet

| Desitin Arzneimittel GmbH |
| --- |
| Weg beim Jäger 214 |
| 22335 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg beim Jäger 214

22335 Hamburg

Tyskland

Orfiril long 1 000 mg

1 000 mg

Depottabletter

Oral anvendelse

Slovakiet

| Ratiopharm GmbH |
| --- |
| Graf-Arco-Strasse 3 |
| 89079 Ulm |
| Tyskland |

Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Tyskland

Valpro-ratiopharm Chrono 500 mg

500 mg

Depottabletter

Oral anvendelse

Slovakiet

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Valproát chrono Sandoz 300 mg tablety s predĺženým uvoľňovaním

300 mg

Depottabletter

Oral anvendelse

Slovakiet

| Sandoz Pharmaceuticals d.d., Verovškova 57 |
| --- |
| 1000 Ljubljana |
| Slovenia |

Sandoz Pharmaceuticals d.d., Verovškova 57

1000 Ljubljana

Slovenia

Valproát chrono Sandoz 500 mg tablety s predľženým uvoľňovaním

500 mg

Depottabletter

Oral anvendelse

Slovenia

| Sanofi-Aventis d.o.o. |
| --- |
| Dunajska c. 119 |
| 1000 Ljubljana |
| Slovenia |

Sanofi-Aventis d.o.o.

Dunajska c. 119

1000 Ljubljana

Slovenia

Depakine chrono 500 mg filmsko obložene tablet s podaljšanim sproščanjem

500 mg

Depottabletter

Oral anvendelse

Slovenia

| Sanofi-Aventis d.o.o. |
| --- |
| Dunajska c. 119 |
| 1000 Ljubljana |
| Slovenia |

Sanofi-Aventis d.o.o.

Dunajska c. 119

1000 Ljubljana

Slovenia

Depakine chrono 300 mg filmsko obložene tablet s podaljšanim sproščanjem

300 mg

Depottabletter

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE 200 mg comprimidos gastrorresistentes

200 mg

Enterotabletter

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE solución oral

200 mg/ml

Oral opløsning

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CRONO 500 mg comprimidos recubiertos

500 mg

Overtrukne tabletter

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CRONO 300 mg comprimidos recubiertos

300 mg

Overtrukne tabletter

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE 500 mg comprimidos gastrorresistentes

500 mg

Enterotabletter

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada

100 mg

Granulat med modificeret udløsning

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CHRONOSPHERE 250 mg granulado de liberación modificada

250 mg

Granulat med modificeret udløsning

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada

500 mg

Granulat med modificeret udløsning

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada

750 mg

Granulat med modificeret udløsning

Oral anvendelse

Spanien

| SANOFI AVENTIS, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

SANOFI AVENTIS, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

DEPAKINE CHRONOSPHERE 1 000 MG Granulado de liberación modificada

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

Spanien

| WINTHROP PHARMA ESPAÑA, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

WINTHROP PHARMA ESPAÑA, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

VALPROATO SODICO CRONO WINTHROP 300 mg comprimidos de liberación prolongada

300 mg

Depottabletter

Oral anvendelse

Spanien

| WINTHROP PHARMA ESPAÑA, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spanien |

WINTHROP PHARMA ESPAÑA, S.A.

Josep Plá, 2

08019 Barcelona

Spanien

VALPROATO SODICO CRONO WINTHROP 500 mg comprimidos de liberación prolongada

500 mg

Depottabletter

Oral anvendelse

Spanien

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Tyskland |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Tyskland

MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA

300 mg

Depotkapsler

Oral anvendelse

Spanien

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Tyskland |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Tyskland

MILZONE 1 000 MG GRÁNULOS DE LIBERACIÓN PROLONGADA

1 000 mg

Depotgranulat

Oral anvendelse

Spanien

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Tyskland |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Tyskland

MILZONE 500 MG GRÁNULOS DE LIBERACIÓN PROLONGADA

500 mg

Depotgranulat

Oral anvendelse

Spanien

| DESITIN ARZNEIMITTEL GMBH |
| --- |
| Weg beim Jäger 214 |
| Hamburgo D-22335 |
| Tyskland |

DESITIN ARZNEIMITTEL GMBH

Weg beim Jäger 214

Hamburgo D-22335

Tyskland

MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA

300 mg

Depotkapsler

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

200 mg/ml

orale dråber, opløsning

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

300 mg

tablet

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

100 mg

Enterotabletter

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

300 mg

Enterotabletter

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

500 mg

Enterotabletter

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor

60 mg/ml

Oral opløsning

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor Depot

300 mg

Depottabletter

Oral anvendelse

Sverige

| Orion Corporation |
| --- |
| Orionintie |
| FI-02200 Espoo |
| Finland |

Orion Corporation

Orionintie

FI-02200 Espoo

Finland

Absenor Depot

500 mg

Depottabletter

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl

200 mg/ml

orale dråber, opløsning

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl

100 mg

Enterotabletter

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl

300 mg

Enterotabletter

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl

500 mg

Enterotabletter

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl

60 mg/ml

Oral opløsning

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

300 mg

Depottabletter

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

500 mg

Depottabletter

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

100 mg

Depotgranulat

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

250 mg

Depotgranulat

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

500 mg

Depotgranulat

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

750 mg

Depotgranulat

Oral anvendelse

Sverige

| Sanofi-aventis AB |
| --- |
| Box 14142 |
| 167 14 Bromma |
| Sverige |

Sanofi-aventis AB

Box 14142

167 14 Bromma

Sverige

Ergenyl Retard

1 000 mg

Depotgranulat

Oral anvendelse

Sverige

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Tyskland

Orfiril

150 mg

Enterotabletter

Oral anvendelse

Sverige

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Tyskland

Orfiril

300 mg

Enterotabletter

Oral anvendelse

Sverige

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Tyskland

Orfiri long

150 mg

Depotkapsler, hård

Oral anvendelse

Sverige

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Tyskland

Orfiril long

300 mg

Depotkapsler, hård

Oral anvendelse

Sverige

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Tyskland

Orfiril long

500 mg

Depotgranulat

Oral anvendelse

Sverige

| Desitin Arzneimittel GmbH |
| --- |
| Weg Beim Jäger 214 |
| 223 35 Hamburg |
| Tyskland |

Desitin Arzneimittel GmbH

Weg Beim Jäger 214

223 35 Hamburg

Tyskland

Orfiril long

1 000 mg

Depotgranulat

Oral anvendelse

England

| Actavis UK Limited |
| --- |
| Whiddon Valley |
| Barnstaple |
| North Devon |
| EX32 8NS |
| England |

Actavis UK Limited

Whiddon Valley

Barnstaple

North Devon

EX32 8NS

England

SODIUM VALPROATE TABLETS BP 200 MG (E/C)

200 mg

Enterotabletter

Oral anvendelse

England

| TEVA UK LIMITED |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex |
| BN22 9AG |
| England |

TEVA UK LIMITED

Brampton Road

Hampden Park

Eastbourne

East Sussex

BN22 9AG

England

SODIUM VALPROATE ENTERIC COATED TABLETS 200 MG

200 mg

Overtrukne tabletter

Oral anvendelse

England

| TEVA UK LIMITED |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne |
| East Sussex |
| BN22 9AG |
| England |

TEVA UK LIMITED

Brampton Road

Hampden Park

Eastbourne

East Sussex

BN22 9AG

England

SODIUM VALPROATE ENTERIC COATED TABLETS 500 MG

500 mg

Overtrukne tabletter

Oral anvendelse

England

| NORTON HEALTHCARE LIMITED |
| --- |
| Albert Basin, Royal Dock |
| Canning Town |
| London E16 2QJ |
| England |

NORTON HEALTHCARE LIMITED

Albert Basin, Royal Dock

Canning Town

London E16 2QJ

England

SODIUM VALPROATE ORAL SOLUTION BP 200 MG/5ML

200 mg/5ml

Oral opløsning

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

DEPAKOTE 250 MG TABLETS

250 mg

Enterotabletter

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

DEPAKOTE 500 MG TABLETS

500 mg

Enterotabletter

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

EPILIM CHRONOSPHERE MR 50 MG MODIFIED RELEASE GRANULES

50 mg

Granulat med modificeret udløsning

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

EPILIM CHRONOSPHERE MR 100 MG MODIFIED RELEASE GRANULES

100 mg

Granulat med modificeret udløsning

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

EPILIM CHRONOSPHERE MR 250 MG MODIFIED RELEASE GRANULES

250 mg

Granulat med modificeret udløsning

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

EPILIM CHRONOSPHERE MR 500 MG MODIFIED RELEASE GRANULES

500 mg

Granulat med modificeret udløsning

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

EPILIM CHRONOSPHERE MR 750 MG MODIFIED RELEASE GRANULES

750 mg

Granulat med modificeret udløsning

Oral anvendelse

England

| AVENTIS PHARMA LIMITED |
| --- |
| 50 Kings Hill Avenue |
| Kings Hill |
| West Malling, Kent. ME194AH |
| England |

AVENTIS PHARMA LIMITED

50 Kings Hill Avenue

Kings Hill

West Malling, Kent. ME194AH

England

EPILIM CHRONOSPHERE MR 1 000 MG MODIFIED RELEASE GRANULES

1 000 mg

Granulat med modificeret udløsning

Oral anvendelse

England

| GENERICS (UK) LIMITED |
| --- |
| Station Close |
| Potters Bar |
| Herts, EN6 1TL |
| England |

GENERICS (UK) LIMITED

Station Close

Potters Bar

Herts, EN6 1TL

England

SODIUM VALPROATE TABLETS BP 200 MG

200 mg

Overtrukne tabletter

Oral anvendelse

England

| GENERICS (UK) LIMITED |
| --- |
| Station Close |
| Potters Bar |
| Herts, EN6 1TL |
| England |

GENERICS (UK) LIMITED

Station Close

Potters Bar

Herts, EN6 1TL

England

SODIUM VALPROATE TABLETS BP 500 MG EC

500 mg

Overtrukne tabletter

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Østrig

CONVULEX CAPSULES 300 MG

300 mg

Enterokapsel

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Østrig

CONVULEX CAPSULES 500 MG

500 mg

Enterokapsel

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Østrig

CONVULEX CAPSULES 150 MG

150 mg

Enterokapsel

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Østrig

CONVULEX CR 300 MG PROLONGED RELEASE TABLETS

300 mg

Depottabletter

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3, |
| A-1160, Vienna, |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3,

A-1160, Vienna,

Østrig

CONVULEX CR 500 MG PROLONGED RELEASE TABLETS

500 mg

Tabletter med modificeret udløsning

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Østrig

EPIVAL CR 500 MG PROLONGED RELEASE TABLETS

500 mg

Depottabletter

Oral anvendelse

England

| GEROT PHARMAZEUTIKA GES.M.B.H |
| --- |
| Arnethgasse 3 |
| A-1160, Vienna |
| Østrig |

GEROT PHARMAZEUTIKA GES.M.B.H

Arnethgasse 3

A-1160, Vienna

Østrig

EPIVAL CR 300 MG PROLONGED RELEASE TABLETS

300 mg

Depottabletter

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM 100 MG CRUSHABLE TABLET

100 mg

tablet

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM 200 EC TABLETS

200 mg

Enterotabletter

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM 500 ENTERIC COATED TABLETS

500 mg

Enterotabletter

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM CHRONO 300 CONTROLLED RELEASE

300 mg

Tabletter med modificeret udløsning

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM LIQUID OR SODIUM VALPROATE 200 MG/5ML LIQUID

200 mg/5ml

Oral opløsning

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM SYRUP 200 MG/5ML

200 mg/5ml

Oral opløsning

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM CHRONO 200 CONTROLLED RELEASE TABLETS 200 MG

200 mg

Tabletter med modificeret udløsning

Oral anvendelse

England

| SANOFI-SYNTHELABO LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

SANOFI-SYNTHELABO LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS 500 MG

500 mg

Tabletter med modificeret udløsning

Oral anvendelse

England

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street |
| Guildford, Surrey |
| GU1 4YS |
| England |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street

Guildford, Surrey

GU1 4YS

England

SODIUM VALPROATE 200 MG ENTERIC COATED TABLETS

200 mg

Enterotabletter

Oral anvendelse

England

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street |
| Guildford Surrey, |
| GU1 4YS |
| England |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street

Guildford Surrey,

GU1 4YS

England

SODIUM VALPROATE 500 MG ENTERIC COATED TABLETS

500 mg

Enterotabletter

Oral anvendelse

England

| RATIOPHARM GMBH |
| --- |
| Graff-Arco Strasse 3, Ulm, D-89079 |
| Tyskland |

RATIOPHARM GMBH

Graff-Arco Strasse 3, Ulm, D-89079

Tyskland

VALPROTEK CR 300 MG (PROLONGED RELEASE) TABLETS

300 mg

Depottabletter

Oral anvendelse

England

| RATIOPHARM GMBH |
| --- |
| Graff-Arco Strasse 3, Ulm, D-89079 |
| Tyskland |

RATIOPHARM GMBH

Graff-Arco Strasse 3, Ulm, D-89079

Tyskland

VALPROTEK CR 500 MG (PROLONGED RELEASE) TABLETS

500 mg

Depottabletter

Oral anvendelse

England

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| England |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

England

SODIUM VALPROATE LIQUID 200 MG/5ML

200 mg

Oral opløsning

Oral anvendelse

England

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| England |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

England

MAPHILEP 200 MG MR TABLETS

200 mg

Depottabletter

Oral anvendelse

England

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| England |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

England

MAPHILEP 300 MG MR TABLETS

300 mg

Tablet med modificeret udløsning

Oral anvendelse

England

| WINTHROP PHARMACEUTICALS UK LIMITED |
| --- |
| 1 Onslow Street, Guildford |
| Surrey, GU1 4YS |
| England |

WINTHROP PHARMACEUTICALS UK LIMITED

1 Onslow Street, Guildford

Surrey, GU1 4YS

England

MAPHILEP 500 MG MR TABLETS

500 mg

Tablet med modificeret udløsning

Oral anvendelse

England

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| England |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

England

EPISENTA 150 MG PROLONGED RELEASE CAPSULES

150 mg

Depotkapsler, hård

Oral anvendelse

England

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| England |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

England

EPISENTA 300 MG PROLONGED RELEASE CAPSULES

300 mg

Depotkapsler, hård

Oral anvendelse

England

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| England |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

England

EPISENTA 500 MG PROLONGED RELEASE CAPSULES

500 mg

Depotgranulat

Oral anvendelse

England

| BEACON PHARMACEUTICALS LIMITED |
| --- |
| 85 High Street |
| Tunbridge Wells, TN1 1YG |
| England |

BEACON PHARMACEUTICALS LIMITED

85 High Street

Tunbridge Wells, TN1 1YG

England

EPISENTA 1 000 MG PROLONGED RELEASE CAPSULES

1 000 mg

Depotgranulat

Oral anvendelse

England

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| England |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

England

ORLEPT (SF) LIQUID OR SODIUM VALPROATE 40 MG/ML ORAL SOLUTION

40 mg/ml

Oral opløsning

Oral anvendelse

England

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| England |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

England

ORLEPT 200 MG GASTRO-RESISTANT TABLETS

200 mg

Enterotabletter

Oral anvendelse

England

| WOCKHARDT UK LIMITED |
| --- |
| Ash Road North |
| Wrexham Industrial Estate |
| Wrexham, LL13 9UF |
| England |

WOCKHARDT UK LIMITED

Ash Road North

Wrexham Industrial Estate

Wrexham, LL13 9UF

England

ORLEPT 500 MG GASTRO-RESISTANT TABLETS

500 mg

Enterotabletter

Oral anvendelse

---

BILAG V

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstaat EU/EEA | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | GUERBET |
| BP 57400 |
| 95943 Roissy Charles de Gaulle Cedex |
| France |

Medlemsstaat EU/EEA

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

GUERBET

BP 57400

95943 Roissy Charles de Gaulle Cedex

France

Dotarem - Injektionslösung

279,32 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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

Injektionsvæske, opløsning/Infusionsvæske

Intravenøs anvendelse

Østrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Østrig

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| Insight Agents GmbH |
| --- |
| Ringstraat 19 B |
| 69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstraat 19 B

69115 Heidelberg

Germany

MAGNEGITA

500 micromol-ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| GE HEALTHCARE BVBA |
| --- |
| Kouterveldstraat 20 |
| 1831 DIEGEM |
| Belgium |

GE HEALTHCARE BVBA

Kouterveldstraat 20

1831 DIEGEM

Belgium

OMNISCAN

0,5 mmol-ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Belgien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Bulgarien

| Bayer Schering Pharma AG |
| --- |
| Muellerstrasse 178 |
| 13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Muellerstrasse 178

13353 Berlin

Germany

Gadovist

604,72 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Bulgarien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Bulgarien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Bulgarien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Bulgarien

| Insight Agents GmbH |
| --- |
| Ringstrasse 19 B |
| D–69115, Heidellberg |
| Germany |

Insight Agents GmbH

Ringstrasse 19 B

D–69115, Heidellberg

Germany

Magnegita

500 micromol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Cypern

| PHADISCO LTD |
| --- |
| 185 YIANNOU GRANIDIOTI AVE, |
| 2235 LATSIA |
| CYPRUS |

PHADISCO LTD

185 YIANNOU GRANIDIOTI AVE,

2235 LATSIA

CYPRUS

OMNISCAN

0,5 MMOL/ML

Injektionsvæske, opløsning

Intravenøs anvendelse

Cypern

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Cypern

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| Guerbet |
| --- |
| BP 57400 |
| 95943 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95943 Roissy CdG cedex

France

Dotarem

279,32 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Den Tjekkiske republik

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Gadovist 1,0 mmol/ml Injektioslösung

604,72 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| Bayer Vital GmbH |
| --- |
| D-51368 Leverkusen |
| Germany |

Bayer Vital GmbH

D-51368 Leverkusen

Germany

Magnevist 0,5 mmol/ml, Injektionslösung

469,01 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| Helm AG |
| --- |
| Nordkanalstr. 28 |
| D-20097 Hamburg |
| Germany |

Helm AG

Nordkanalstr. 28

D-20097 Hamburg

Germany

Gadopentetat Dimeglumin Helm AG Injektionslösung

469 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Tyskland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Danmark

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Estland

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

MAGNEVIST

469 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Estland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Estland

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

GADOVIST

1 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Estland

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

PRIMOVIST

0,25 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Estland

| Bayer Schering Pharma AG |
| --- |
| DE-13342 Berlin- |
| Germany |

Bayer Schering Pharma AG

DE-13342 Berlin-

Germany

PRIMOVIST

0,25 mmol/ml

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Estland

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

MAGNEGITA

469 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning, Injektionssprøjte

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning (syringe)

Intravenøs anvendelse

Spanien

| 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)

Injektionsvæske, opløsning (syringe)

Intravenøs anvendelse

Spanien

| 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)

Injektionsvæske, opløsning Hætteglas

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning Hætteglas

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning Injektionssprøjte og Cylinderampul

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning (syringe)

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| 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

Injektionsvæske, opløsning (syringe)

Intravenøs anvendelse

Spanien

| Guerbet |
| --- |
| BP 57400 |
| 95493 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95493 Roissy CdG cedex

France

Dotarem

0,5 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Spanien

| Guerbet |
| --- |
| BP 57400 |
| 95493 Roissy CdG cedex |
| France |

Guerbet

BP 57400

95493 Roissy CdG cedex

France

Dotarem

0,5 mmol/ml

Injektionsvæske, opløsning (syringe)

Intravenøs anvendelse

Finland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47 |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47

20210 Turku

Finland

MAGNEVIST

0,5 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B, |
| 69115 HEIDELBERG |
| Germany |

Insight Agents GmbH

Ringstr. 19 B,

69115 HEIDELBERG

Germany

MAGNEGITA

500 micromol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B, |
| 69115 HEIDELBERG |
| Germany |

Insight Agents GmbH

Ringstr. 19 B,

69115 HEIDELBERG

Germany

GADOPENTETATE INSIGHT

500 micromol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

PRIMOVIST

0,25 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

PRIMOVIST

0,25 mmol/ml

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Finland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

GADOVIST

1 mmol/ml

Injektionsvæske, opløsning (syringe)

Intravenøs anvendelse

Finland

| Bayer Schering Pharma Oy |
| --- |
| Pansiontie 47, |
| 20210 Turku |
| Finland |

Bayer Schering Pharma Oy

Pansiontie 47,

20210 Turku

Finland

GADOVIST

1 mmol/ml

Injektionsvæske, opløsning Injektionssprøjte

Intravenøs anvendelse

Finland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Frankrig

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Grækenland

| GE HEALTHCARE |
| --- |
| PLAPOUTA 139 & LAMIAS ST |
| NEO IRAKLEIO 14121 |
| GREECE |

GE HEALTHCARE

PLAPOUTA 139 & LAMIAS ST

NEO IRAKLEIO 14121

GREECE

OMNISCAN

287 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Grækenland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Grækenland

| GEROLYMATOS P.G.N. AEBE |
| --- |
| ASKLIPIOU ST KRYONERI |
| ATTICA |
| GREECE |

GEROLYMATOS P.G.N. AEBE

ASKLIPIOU ST KRYONERI

ATTICA

GREECE

MULTIHANCE

529 mg/mlm

Injektionsvæske, opløsning

Intravenøs anvendelse

Grækenland

| GEROLYMATOS P.G.N. AEBE |
| --- |
| ASKLIPIOU ST KRYONERI |
| ATTICA |
| GREECE |

GEROLYMATOS P.G.N. AEBE

ASKLIPIOU ST KRYONERI

ATTICA

GREECE

MULTIHANCE

529 mg/mlm

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Grækenland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Grækenland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Grækenland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Grækenland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Grækenland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

GR-Greece

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, Fyldt injektionssprøjte

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Ungarn

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning, Fyldt cylinderampul

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Irland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Island

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Island

| 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

Injektionsvæske, opløsning,Fyldt injektionssprøjte

Intravenøs anvendelse

Island

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Island

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| GE Healthcare |
| --- |
| Via Galeno 36, |
| 20126 Milano |
| Italy |

GE Healthcare

Via Galeno 36,

20126 Milano

Italy

Omniscan

287 mg/ml (0,5 mmol/ml)

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| 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)

Infusionsvæske, opløsning

Intravenøs anvendelse

Italien

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| Bayer SpA |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italy |

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Gadovist

604,72 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Italien

| Bayer SpA |
| --- |
| Viale Certosa, 130 |
| 20156 Milano |
| Italy |

Bayer SpA

Viale Certosa, 130

20156 Milano

Italy

Primovist

0,25 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Litauen

| Bayer Schering Pharma AG |
| --- |
| Müllerstrasse 178 |
| DE-13353 Berlin |
| Germany |

Bayer Schering Pharma AG

Müllerstrasse 178

DE-13353 Berlin

Germany

Gadovist

1 mmol/ml

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Litauen

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Litauen

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Litauen

| 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

Injektionsvæske, opløsning/Infusionsvæske

Intravenøs anvendelse

Litauen

| Insight Agents GmbH |
| --- |
| Ringstr. 19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr. 19 B

D-69115 Heidelberg

Germany

Magnegita

500 micromol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Litauen

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| Codali S.A. |
| --- |
| Avenue Henri Dunant 31 |
| 1140 Bruxelles |
| Belgium |

Codali S.A.

Avenue Henri Dunant 31

1140 Bruxelles

Belgium

DOTAREM

37,7 G

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| GE HEALTHCARE BVBA |
| --- |
| Kouterveldstraat 20 |
| 1831 DIEGEM |
| Belgium |

GE HEALTHCARE BVBA

Kouterveldstraat 20

1831 DIEGEM

Belgium

OMNISCAN

287 MG/1 ML

Injektionsvæske, opløsning

Intravenøs anvendelse

Luxembourg

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Letland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Letland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Letland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Letland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Letland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Letland

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

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)

Injektionsvæske, opløsning

Intravenøs anvendelse

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

Injektionsvæske, opløsning

Intravenøs anvendelse

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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Holland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Gadovisit

1,0 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Magnevist

0,5 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| Bayer B.V. |
| --- |
| Energieweg 1 |
| 3641 RT MIJDRECHT |
| Netherlands |

Bayer B.V.

Energieweg 1

3641 RT MIJDRECHT

Netherlands

Primovist

0,25 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Holland

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Norge

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Polen

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Polen

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Polen

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Gadovist 1,0

604,72 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Polen

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Magnevist

469 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Polen

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Polen

| Bayer Schering Pharma AG |
| --- |
| D-13342 Berlin |
| Germany |

Bayer Schering Pharma AG

D-13342 Berlin

Germany

Primovist

0,25 mmol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Portugal

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Portugal

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Portugal

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Portugal

| 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

Injektionsvæske, opløsning (Fyldt injektionssprøjte)

Intravenøs anvendelse

Portugal

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Portugal

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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)

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Rumænien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| Bracco SpA |
| --- |
| Via Egidio Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio Folli 50

I-20134 Milan

Italy

Multihance

334 mg/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| Bracco SpA |
| --- |
| Via Egidio. Folli 50 |
| I-20134 Milan |
| Italy |

Bracco SpA

Via Egidio. Folli 50

I-20134 Milan

Italy

Multihance

334 mg/ml

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning, Fyldt injektionssprøjte

Intravenøs anvendelse

Sverige

| Insight Agents GmbH |
| --- |
| Ringstr.19 B |
| D-69115 Heidelberg |
| Germany |

Insight Agents GmbH

Ringstr.19 B

D-69115 Heidelberg

Germany

Magnegita

500 mikromol/ml

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Sverige

| 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

Injektionsvæske, opløsning Fyldt injektionssprøjte

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovenien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovakiet

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovakiet

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovakiet

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovakiet

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Slovakiet

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

Storbritannien

| 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

Injektionsvæske, opløsning

Intravenøs anvendelse

---

BILAG VI

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat EU/EE | Indehaver af markedsføringstilladelse | Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien, |
| Østrig |

Medlemsstat EU/EE

Indehaver af markedsføringstilladelse

Navn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien,

Østrig

Valtrex 1 000 mg - Filmtabletten

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| Østrig |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

Østrig

Valaciclovir Sandoz 1 000 mg - Filmtabletten

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien |
| Østrig |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

Østrig

Valtrex 500 mg - Filmtabletten

500 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| Østrig |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

Østrig

Valaciclovir Sandoz 500 mg - Filmtabletten

500 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| --- |
| A-1140 Wien, |
| Østrig |

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien,

Østrig

Valtrex 250 mg - Filmtabletten

250 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| Sandoz GmbH |
| --- |
| Biochemiestraße 10, |
| 6250 Kundl |
| Østrig |

Sandoz GmbH

Biochemiestraße 10,

6250 Kundl

Østrig

Valaciclovir Sandoz 250 mg - Filmtabletten

250 mg

Filmovertrukken tablet

Oral anvendelse

Belgien

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgien

Zelitrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Belgien

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgien

Zelitrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| Glaxo Group Ltd |
| --- |
| Greenford Road |
| Greenford |
| Middlesex UB6 0NN |
| Storbritannien |

Glaxo Group Ltd

Greenford Road

Greenford

Middlesex UB6 0NN

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Cypern

| Glaxo Group Limited |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex, UB6 0NN, |
| Storbritannien |

Glaxo Group Limited

Berkeley Avenue

Greenford

Middlesex, UB6 0NN,

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| The Wellcome Foundation Ltd., Glaxo Wellcome House |
| --- |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| Storbritannien |

The Wellcome Foundation Ltd., Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

Storbritannien

Valtrex 500 mg

500 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Danmark |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Danmark

Zelitrex

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Danmark |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Danmark

Zelitrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| GlaxoSmithKline Pharma A/S, Nykaer 68 |
| --- |
| 2605 Broendby, |
| Danmark |

GlaxoSmithKline Pharma A/S, Nykaer 68

2605 Broendby,

Danmark

Zelitrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Estland

| Glaxo Wellcome Operations |
| --- |
| Glaxo Wellcome House, |
| Berkeley Avenue, Greenford, |
| Middlesex UB6 0NN, |
| Storbritannien |

Glaxo Wellcome Operations

Glaxo Wellcome House,

Berkeley Avenue, Greenford,

Middlesex UB6 0NN,

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| The Wellcome Foundation Ltd. Greenford, |
| --- |
| Middlesex, |
| Storbritannien |

The Wellcome Foundation Ltd. Greenford,

Middlesex,

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Orion Corporation |
| --- |
| Orionintie 1 |
| FI-02200 Espoo, |
| Finland |

Orion Corporation

Orionintie 1

FI-02200 Espoo,

Finland

Valavir

500 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| GlaxoSmithKline Oy |
| --- |
| Piispansilta 9 A, |
| 02230 Espoo, |
| Finland |

GlaxoSmithKline Oy

Piispansilta 9 A,

02230 Espoo,

Finland

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, Frankrig |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, Frankrig

Zelitrex 500 mg, comprimé enrobé

500 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, Frankrig |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, Frankrig

Zelitrex 1 000 mg, comprimé enrobé

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Laboratoires BIOGARAN 15, boulevard Charles de Gaulle |
| --- |
| 92707 COLOMBES Cedex |
| Frankrig |

Laboratoires BIOGARAN 15, boulevard Charles de Gaulle

92707 COLOMBES Cedex

Frankrig

Valaciclovir Biogaran 500 mg, comprimé enrobé

500 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| Laboratoire GlaxoSmithKline |
| --- |
| 100 route de Versailles |
| 78163 Marly-le-Roi cedex, Frankrig |

Laboratoire GlaxoSmithKline

100 route de Versailles

78163 Marly-le-Roi cedex, Frankrig

Valaciclovir GSK 500 mg, comprimé enrobé

500 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| sanofi-aventis France |
| --- |
| 1 – 13 boulevard Romain Rolland |
| 75014 PARIS |
| Frankrig |

sanofi-aventis France

1 – 13 boulevard Romain Rolland

75014 PARIS

Frankrig

Valaciclovir Winthrop 500 mg, comprimé enrobé

500 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Tyskland |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Tyskland

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Tyskland |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Tyskland

Valtrex S

500 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11, |
| --- |
| 80339 München, |
| Tyskland |

GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,

80339 München,

Tyskland

Valtrex S 250 mg

250 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Grækenland |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Grækenland

Valtrex

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Grækenland |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Grækenland

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens, |
| Grækenland |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens,

Grækenland

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Island

| GlaxoSmithKline ehf. |
| --- |
| Þverholt 14 |
| 105 Reykjavík, |
| Island |

GlaxoSmithKline ehf.

Þverholt 14

105 Reykjavík,

Island

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Island

| GlaxoSmithKline ehf. |
| --- |
| Þverholt 14 |
| 105 Reykjavík, |
| Island |

GlaxoSmithKline ehf.

Þverholt 14

105 Reykjavík,

Island

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Irland

GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Irland

Valtrex 500 mg Film-coated Tablet

500 mg

Filmovertrukken tablet

Oral anvendelse

Irland

GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Irland

Valtrex 250 mg Film-coated Tablet

250 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| Italien |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

Italien

Zelitrex

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| Italien |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

Italien

Talavir

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| Italien |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

Italien

Zelitrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| Italien |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

Italien

Talavir

500 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona, |
| Italien |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona,

Italien

Zelitrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| Sigma Tau Industrie Farmaceutiche Riunite S.p.A |
| --- |
| Viale Shakespeare, 47 – 00144 Roma, |
| Italien |

Sigma Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare, 47 – 00144 Roma,

Italien

Talavir

250 mg

Filmovertrukken tablet

Oral anvendelse

Letland

| GlaxoSmithKline Latvia SIA, Bruņinieku iela 5, |
| --- |
| Riga, LV-1001 |
| Letland |

GlaxoSmithKline Latvia SIA, Bruņinieku iela 5,

Riga, LV-1001

Letland

Valtrex 500 mg film-coated tablets

500 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

| The Wellcome Foundation Ltd, |
| --- |
| Glaxo Wellcome House, Berkeley Avenue, |
| Greenford, |
| Middlesex UB6 0NN, |
| Storbritannien |

The Wellcome Foundation Ltd,

Glaxo Wellcome House, Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgien

Zelitrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgien

Zelitrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Malta

| The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford, |
| --- |
| Middlesex, UB6 ONN, |
| Storbritannien |

The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford,

Middlesex, UB6 ONN,

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Holland

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZZeist, |
| Holland |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZZeist,

Holland

Zelitrex 500 mg

500 mg

Filmovertrukken tablet

Oral anvendelse

Holland

| GlaxoSmithKline BV |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ Zeist, |
| Holland |

GlaxoSmithKline BV

Huis ter Heideweg 62

3705 LZ Zeist,

Holland

Zelitrex 250 mg

250 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| Norge |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

Norge

Valtrex

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| Norge |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

Norge

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| GlaxoSmithKline AS |
| --- |
| Forskningsveien 2A |
| Postboks 180 Vinderen |
| 0319 Oslo, |
| Norge |

GlaxoSmithKline AS

Forskningsveien 2A

Postboks 180 Vinderen

0319 Oslo,

Norge

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex, |
| --- |
| TW8 9GS |
| Storbritannien |

GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex,

TW8 9GS

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Portugal

Valtrex

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Portugal |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Portugal

Valavir

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Portugal

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Portugal |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Portugal

Valavir

500 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3 |
| --- |
| Arquiparque - Miraflores |
| 1495-131 Algés |
| Portugal |

Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3

Arquiparque - Miraflores

1495-131 Algés

Portugal

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| Alter, SAEstrada Marco do Grilo |
| --- |
| Zemouto - Coina |
| 2830 Barreiro |
| Portugal |

Alter, SAEstrada Marco do Grilo

Zemouto - Coina

2830 Barreiro

Portugal

Valavir

250 mg

Filmovertrukken tablet

Oral anvendelse

Rumænien

| The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue, |
| --- |
| Greenford, |
| Middlesex UB6 0NN, |
| Storbritannien |

The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue,

Greenford,

Middlesex UB6 0NN,

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| GlaxoSmithKline Slovakia s.r.o., |
| --- |
| Galvaniho 7/A, |
| 82104 Bratislava |
| Slovakiet |

GlaxoSmithKline Slovakia s.r.o.,

Galvaniho 7/A,

82104 Bratislava

Slovakiet

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Slovenien

| GSK do.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| 1001 Ljubljana |
| Slovenien |

GSK do.o., Ljubljana

Knezov štradon 90

1001 Ljubljana

Slovenien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Valtrex

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Virval

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Allen Farmacéutica S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

Allen Farmacéutica S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Valaciclovir Allen

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Smithkline Beecham Farma S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

Smithkline Beecham Farma S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Valherpes

1 000 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| GlaxoSmithKline, S.A |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

GlaxoSmithKline, S.A

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| GlaxoSmithKline, S.A Severo Ochoa, 2, 28760, |
| --- |
| Tres Cantos Madrid |
| Spanien |

GlaxoSmithKline, S.A Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Virval

500 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Allen Farmacéutica S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

Allen Farmacéutica S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Valaciclovir Allen

500 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Smithkline Beecham Farma S.A. |
| --- |
| Severo Ochoa, 2, 28760, |
| Tres Cantos Madrid |
| Spanien |

Smithkline Beecham Farma S.A.

Severo Ochoa, 2, 28760,

Tres Cantos Madrid

Spanien

Valherpes

500 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| Sverige |

GlaxoSmithKline AB

Box 516

169 29 Solna,

Sverige

Valtrex

1 g

Filmovertrukken tablet

Oral anvendelse

Sverige

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| Sverige |

GlaxoSmithKline AB

Box 516

169 29 Solna,

Sverige

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| GlaxoSmithKline AB |
| --- |
| Box 516 |
| 169 29 Solna, |
| Sverige |

GlaxoSmithKline AB

Box 516

169 29 Solna,

Sverige

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| The Wellcome Foundation Ltd |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| Storbritannien |

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

Storbritannien

Trading as;

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| Storbritannien |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Storbritannien

Valtrex

500 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| The Wellcome Foundation Ltd |
| --- |
| Glaxo Wellcome House |
| Berkeley Avenue |
| Greenford |
| Middlesex |
| UB6 0NN, |
| Storbritannien |

The Wellcome Foundation Ltd

Glaxo Wellcome House

Berkeley Avenue

Greenford

Middlesex

UB6 0NN,

Storbritannien

Trading as;

| GlaxoSmithKline UK |
| --- |
| Stockley Park West |
| Uxbridge |
| Middlesex |
| UB11 1BT |
| Storbritannien |

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Storbritannien

Valtrex

250 mg

Filmovertrukken tablet

Oral anvendelse

---

BILAG VII

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, ANSØGERE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsstat EU/EEA | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Novartis Pharma GmbH |
| Brunner Strasse 59 |
| 1235 Wien |
| Østrig |

Medlemsstat EU/EEA

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

Østrig

Famvir 125 mg – Filmtabletten

125 mg

Filmovertrukne tabletter

Oral anvendelse

Østrig

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| Østrig |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

Østrig

Famvir 250 mg – Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Østrig

| Novartis Pharma GmbH |
| --- |
| Brunner Strasse 59 |
| 1235 Wien |
| Østrig |

Novartis Pharma GmbH

Brunner Strasse 59

1235 Wien

Østrig

Famvir 500 mg – Filmtabletten

500 mg

Filmovertrukne tabletter

Oral anvendelse

Cypern

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kasou P.O. Box 23490 |
| Nicosia |
| Cypern |

Demetriades & Papaellinas Ltd

21 Kasou P.O. Box 23490

Nicosia

Cypern

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Cypern

| Demetriades & Papaellinas Ltd |
| --- |
| 21 Kasou P.O. Box 23490 |
| Nicosia |
| Cypern |

Demetriades & Papaellinas Ltd

21 Kasou P.O. Box 23490

Nicosia

Cypern

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Danmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Danmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Danmark

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Danmark

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Danmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Danmark

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Finland

| Novartis Finland Oy |
| --- |
| Metsänneidonkuja 10 |
| FI-02130 Espoo |
| Finland |

Novartis Finland Oy

Metsänneidonkuja 10

FI-02130 Espoo

Finland

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Frankrig

| Novartis Pharma S.A.S. |
| --- |
| 2 - 4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| Frankrig |

Novartis Pharma S.A.S.

2 - 4, rue Lionel Terray

92500 Rueil-Malmaison

Frankrig

Oravir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Frankrig

| Novartis Pharma S.A.S. |
| --- |
| 2 - 4, rue Lionel Terray |
| 92500 Rueil-Malmaison |
| Frankrig |

Novartis Pharma S.A.S.

2 - 4, rue Lionel Terray

92500 Rueil-Malmaison

Frankrig

Oravir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Tyskland |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Tyskland

Famvir 125 mg Filmtabletten

125 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Tyskland |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Tyskland

Famvir 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| 90429 Nürnberg |
| Tyskland |

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Tyskland

Famvir Zoster 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Tyskland |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Tyskland

Famciclovir-Sandoz 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Tyskland |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Tyskland

Famciclovir-Sandoz 500 mg Filmtabletten

500 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Tyskland |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Tyskland

Famciclovir-SB 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Grünwalder Gesundheitsprodukte GmbH |
| --- |
| Ruhlandstr. 5 |
| 83646 Bad Tölz |
| Tyskland |

Grünwalder Gesundheitsprodukte GmbH

Ruhlandstr. 5

83646 Bad Tölz

Tyskland

Famciclovir-SB Zoster 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Grækenland |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Grækenland

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Grækenland |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Grækenland

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Novartis (Hellas) S.A.C.I. |
| --- |
| 12th Km National Road No. 1 |
| GR-144 51 Metamorphosis |
| Grækenland |

Novartis (Hellas) S.A.C.I.

12th Km National Road No. 1

GR-144 51 Metamorphosis

Grækenland

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Ungarn

| Novartis Hungaria Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Ungarn |

Novartis Hungaria Kft.

Bartók Béla út 43-47

H-1114 Budapest

Ungarn

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Ungarn

| Novartis Hungaria Kft. |
| --- |
| Bartók Béla út 43-47 |
| H-1114 Budapest |
| Ungarn |

Novartis Hungaria Kft.

Bartók Béla út 43-47

H-1114 Budapest

Ungarn

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Island

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Danmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Danmark

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Island

| Novartis Healthcare A/S |
| --- |
| Lyngbyvej 172 |
| 2100 Kopenhagen Ø |
| Danmark |

Novartis Healthcare A/S

Lyngbyvej 172

2100 Kopenhagen Ø

Danmark

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

750 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italien |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italien

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italien |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italien

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Novartis Farma S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italien |

Novartis Farma S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italien

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italien |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italien

Famciclovir Sandoz

125 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italien |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italien

Famciclovir Sandoz

250 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Sandoz S.p.A. |
| --- |
| Largo Umberto Boccioni 1 |
| I-21040 Origgio |
| Italien |

Sandoz S.p.A.

Largo Umberto Boccioni 1

I-21040 Origgio

Italien

Famciclovir Sandoz

500 mg

Filmovertrukne tabletter

Oral anvendelse

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Tyskland |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Tyskland

Famvir 125 mg Filmtabletten

125 mg

Filmovertrukne tabletter

Oral anvendelse

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Tyskland |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Tyskland

Famvir 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Luxembourg

| Novartis Pharma GmbH |
| --- |
| Roonstrasse 25 |
| D-90429 Nürnberg |
| Tyskland |

Novartis Pharma GmbH

Roonstrasse 25

D-90429 Nürnberg

Tyskland

Famvir Zoster 250 mg Filmtabletten

250 mg

Filmovertrukne tabletter

Oral anvendelse

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Malta

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Holland

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| Holland |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

Holland

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Holland

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| Holland |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

Holland

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Holland

| Novartis Pharma B.V. |
| --- |
| P.O. Box 241 |
| 6800 LZ Arnhem |
| Holland |

Novartis Pharma B.V.

P.O. Box 241

6800 LZ Arnhem

Holland

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanien |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanien

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanien |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanien

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanien |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanien

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Novartis Farmacéutica S.A. |
| --- |
| Gran Via de les Corts Catalanes 764. |
| E-08013 Barcelona |
| Spanien |

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes 764.

E-08013 Barcelona

Spanien

Famvir

750 mg

Filmovertrukne tabletter

Oral anvendelse

Sverige

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sverige |

Novartis Sverige AB

Box 1150

183 11 Täby

Sverige

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Sverige

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sverige |

Novartis Sverige AB

Box 1150

183 11 Täby

Sverige

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Sverige

| Novartis Sverige AB |
| --- |
| Box 1150 |
| 183 11 Täby |
| Sverige |

Novartis Sverige AB

Box 1150

183 11 Täby

Sverige

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

125 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

250 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

500 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Novartis Pharmaceuticals UK Ltd |
| --- |
| Frimley Business Park |
| Frimley, Camberley |
| Surrey GU16 7SR |
| Storbritannien |

Novartis Pharmaceuticals UK Ltd

Frimley Business Park

Frimley, Camberley

Surrey GU16 7SR

Storbritannien

Famvir

750 mg

Filmovertrukne tabletter

Oral anvendelse

---

BILAG VIII

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat EU | Indehaver af markedsførings-tilladelse | SærNavn Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Roche Austria GmbH, |
| Engelhorngasse 3, |
| A - 1211 VienNa |
| Østrig |

Medlemsstat EU

Indehaver af markedsførings-tilladelse

SærNavn Navn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 VienNa

Østrig

Inhibace »Roche« 0,5 mg - Filmtabletten

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Østrig

| Roche Austria GmbH, |
| --- |
| Engelhorngasse 3, |
| A - 1211 VienNa |
| Østrig |

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 VienNa

Østrig

Inhibace »Roche« 2,5 mg - Filmtabletten

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Østrig

| Roche Austria GmbH, |
| --- |
| Engelhorngasse 3, |
| A - 1211 VienNa |
| Østrig |

Roche Austria GmbH,

Engelhorngasse 3,

A - 1211 VienNa

Østrig

Inhibace »Roche« 5 mg - Filmtabletten

5 mg

Filmovertrukne tabletter

Oral anvendelse

Belgien

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgien |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgien

Inhibace

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Belgien

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgien |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgien

Inhibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Bulgarien

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Bulgarien |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Bulgarien

Inhibace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Bulgarien

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Bulgarien |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Bulgarien

Inhibace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Bulgarien

| Roche Bulgaria EOOD |
| --- |
| 16, Bvalo pole Str. |
| 1618 / Sofia |
| Bulgarien |

Roche Bulgaria EOOD

16, Bvalo pole Str.

1618 / Sofia

Bulgarien

Inhibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Tjekkiet

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Tjekkiet |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Tjekkiet

Inhibace 2,5 mg

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Tjekkiet

| Roche s.r.o. |
| --- |
| Dukelskych hrdinu 567/52 |
| 170 00 / Praha 7 |
| Tjekkiet |

Roche s.r.o.

Dukelskych hrdinu 567/52

170 00 / Praha 7

Tjekkiet

Inhibace 5 mg

5 mg

Filmovertrukne tabletter

Oral anvendelse

Frankrig

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| Frankrig |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

Frankrig

Justor 0,5 mg

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Frankrig

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| Frankrig |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

Frankrig

Justor 1 mg

1 mg

Filmovertrukne tabletter

Oral anvendelse

Frankrig

| Chiesi SA |
| --- |
| Immeuble le Doublon, bâtiment B |
| 11 avenue Dubonnet |
| 92 400 Courbevoie |
| Frankrig |

Chiesi SA

Immeuble le Doublon, bâtiment B

11 avenue Dubonnet

92 400 Courbevoie

Frankrig

Justor 2,5 mg

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Tyskland |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Tyskland

Dynorm 0,5

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Tyskland |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Tyskland

Dynorm 1,0

1 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Tyskland |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Tyskland

Dynorm 2,5

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Tyskland

| Roche Pharma AG |
| --- |
| Emil-Barell-Strasse 1 |
| 79639/Grenzach |
| Tyskland |

Roche Pharma AG

Emil-Barell-Strasse 1

79639/Grenzach

Tyskland

Dynorm 5,0

5 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Roche (Hellas) SA |
| --- |
| 4, AlamaNas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Grækenland |

Roche (Hellas) SA

4, AlamaNas & Delfon Str.

Maroussi 15125

Attiki

Grækenland

Vascace

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Roche (Hellas) SA |
| --- |
| 4, AlamaNas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Grækenland |

Roche (Hellas) SA

4, AlamaNas & Delfon Str.

Maroussi 15125

Attiki

Grækenland

Vascace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Roche (Hellas) SA |
| --- |
| 4, AlamaNas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Grækenland |

Roche (Hellas) SA

4, AlamaNas & Delfon Str.

Maroussi 15125

Attiki

Grækenland

Vascace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Grækenland

| Roche (Hellas) SA |
| --- |
| 4, AlamaNas & Delfon Str. |
| Maroussi 15125 |
| Attiki |
| Grækenland |

Roche (Hellas) SA

4, AlamaNas & Delfon Str.

Maroussi 15125

Attiki

Grækenland

Vascace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Ungarn

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Ungarn |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Ungarn

Inhibace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Ungarn

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Ungarn |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Ungarn

Inhibace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Ungarn

| Roche Hungary Ltd |
| --- |
| Edison ut 1 |
| 2040 / Budaörs |
| Ungarn |

Roche Hungary Ltd

Edison ut 1

2040 / Budaörs

Ungarn

Inhibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Irland

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| Italien |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

Italien

Inibace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Italien

| Roche S.p.A |
| --- |
| Via G.B Stucchi 110 |
| 20052/Monza |
| Italien |

Roche S.p.A

Via G.B Stucchi 110

20052/Monza

Italien

Inibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Luxembourg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgien |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgien

Inhibace

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Luxembourg

| N.V. Roche S.A. |
| --- |
| Rue Dante 75 |
| 1070 Bruxelles |
| Belgien |

N.V. Roche S.A.

Rue Dante 75

1070 Bruxelles

Belgien

Inhibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Holland

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| Holland |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

Holland

Vascase 0,5

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Holland

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| Holland |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

Holland

Vascase 2,5

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Holland

| Roche Nederland BV |
| --- |
| Beneluxlaan 2A |
| 3446 GG Woerden |
| Holland |

Roche Nederland BV

Beneluxlaan 2A

3446 GG Woerden

Holland

Vascase 5

5 mg

Filmovertrukne tabletter

Oral anvendelse

Polen

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Polen |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Polen

Inhibace

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Polen

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Polen |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Polen

Inhibace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Polen

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Polen |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Polen

Inhibace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Polen

| Roche Polska Sp.z.o.o. |
| --- |
| Ul. Domaniewska 39B |
| 02-672 / Warsaw |
| Polen |

Roche Polska Sp.z.o.o.

Ul. Domaniewska 39B

02-672 / Warsaw

Polen

Inhibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Portugal

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada NacioNal 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda.

Estrada NacioNal 249-1

2720-413 / Amadora

Portugal

Inibace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Portugal

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada NacioNal 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda.

Estrada NacioNal 249-1

2720-413 / Amadora

Portugal

Inibace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Portugal

| Roche Farmacêutica Química, Lda. |
| --- |
| Estrada NacioNal 249-1 |
| 2720-413 / Amadora |
| Portugal |

Roche Farmacêutica Química, Lda.

Estrada NacioNal 249-1

2720-413 / Amadora

Portugal

Inibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spanien |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spanien

Inhibace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spanien |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spanien

Inhibace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Spanien

| Roche Farma S.A. |
| --- |
| Eucalipto no 33 |
| 28016 / Madrid |
| Spanien |

Roche Farma S.A.

Eucalipto no 33

28016 / Madrid

Spanien

Inhibace

5 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

0,5 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

1 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

2,5 mg

Filmovertrukne tabletter

Oral anvendelse

Storbritannien

| Roche Products Ltd |
| --- |
| 6 Falcon Way, Shire Park |
| WelwynGardenCity / AL7 1TW |
| Storbritannien |

Roche Products Ltd

6 Falcon Way, Shire Park

WelwynGardenCity / AL7 1TW

Storbritannien

Vascace

5 mg

Filmovertrukne tabletter

Oral anvendelse

---

BILAG IX

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat EU/EØS | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | AstraZeneca Österreich GmbH., |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

Medlemsstat EU/EØS

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 2 mg - Tabletten

2 mg

Tablet

Oral anvendelse

Østrig

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 4 mg - Tabletten

4 mg

Tablet

Oral anvendelse

Østrig

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 8 mg - Tabletten

8 mg

Tablet

Oral anvendelse

Østrig

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 16 mg - Tabletten

16 mg

Tablet

Oral anvendelse

Østrig

| AstraZeneca Österreich GmbH., |
| --- |
| Schwarzenbergplatz 7, |
| A-1037 Wien, Austria |

AstraZeneca Österreich GmbH.,

Schwarzenbergplatz 7,

A-1037 Wien, Austria

Atacand 32 mg - Tabletten

32 mg

Tablet

Oral anvendelse

Østrig

| 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

Tablet

Oral anvendelse

Østrig

| 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

Tablet

Oral anvendelse

Østrig

| 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

Tablet

Oral anvendelse

Østrig

| 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

Tablet

Oral anvendelse

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

2 mg

Tablet

Oral anvendelse

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

4 mg

Tablet

Oral anvendelse

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

8 mg

Tablet

Oral anvendelse

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

16 mg

Tablet

Oral anvendelse

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

32 mg

Tablet

Oral anvendelse

Bulgarien

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Bulgarien

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Bulgarien

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral anvendelse

Cypern

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

4 mg

Tablet

Oral anvendelse

Cypern

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Cypern

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Cypern

| AstraZeneca AB, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral anvendelse

Tjekkiet

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 4 mg

4 mg

Tablet

Oral anvendelse

Tjekkiet

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 8 mg

8 mg

Tablet

Oral anvendelse

Tjekkiet

| AstraZeneca UK Ltd., Macclesfield, |
| --- |
| Cheshire, United Kingdom |

AstraZeneca UK Ltd., Macclesfield,

Cheshire, United Kingdom

Atacand 16 mg

16 mg

Tablet

Oral anvendelse

Danmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

4 mg

Tablet

Oral anvendelse

Danmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

8 mg

Tablet

Oral anvendelse

Danmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

16 mg

Tablet

Oral anvendelse

Danmark

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22

DK-2620 Albertslund,

Denmark

Atacand

32 mg

Tablet

Oral anvendelse

Estland

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Estland

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Estland

| AstraZeneca AB, Strängnäsvägen 44, |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB, Strängnäsvägen 44,

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral anvendelse

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

2 mg

Tablet

Oral anvendelse

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

4 mg

Tablet

Oral anvendelse

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

8 mg

Tablet

Oral anvendelse

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

16 mg

Tablet

Oral anvendelse

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Atacand

32 mg

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Frankrig

| 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

Tablet

Oral anvendelse

Tyskland

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 4 mg

4 mg

Tablet

Oral anvendelse

Tyskland

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 8 mg

8 mg

Tablet

Oral anvendelse

Tyskland

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand 16 mg

16 mg

Tablet

Oral anvendelse

Tyskland

| AstraZeneca GmbH |
| --- |
| 22876 Wedel, Germany |

AstraZeneca GmbH

22876 Wedel, Germany

Atacand PROTECT 32 mg Tabletten

32 mg

Tablet

Oral anvendelse

Tyskland

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 2 mg Tabletten

2 mg

Tablet

Oral anvendelse

Tyskland

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 4 mg Tabletten

4 mg

Tablet

Oral anvendelse

Tyskland

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 8 mg Tabletten

8 mg

Tablet

Oral anvendelse

Tyskland

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 16 mg Tabletten

16 mg

Tablet

Oral anvendelse

Tyskland

| Takeda Pharma GmbH |
| --- |
| Viktoriaallee 3-5 |
| 52066 Aachen |
| Germany |

Takeda Pharma GmbH

Viktoriaallee 3-5

52066 Aachen

Germany

Blopress 32 mg Tabletten

32 mg

Tablet

Oral anvendelse

Grækenland

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

2 mg

Tablet

Oral anvendelse

Grækenland

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

4 mg

Tablet

Oral anvendelse

Grækenland

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

8 mg

Tablet

Oral anvendelse

Grækenland

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

16 mg

Tablet

Oral anvendelse

Grækenland

| AstraZeneca SA |
| --- |
| Theotokopoulou 4 & Astronafton |
| 151 25 Maroussi |
| Greece |

AstraZeneca SA

Theotokopoulou 4 & Astronafton

151 25 Maroussi

Greece

Atacand

32 mg

Tablet

Oral anvendelse

Ungarn

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest,

Bocskai út 134-146

Hungary

Atacand

8 mg

Tablet

Oral anvendelse

Ungarn

| AstraZeneca Kft. |
| --- |
| 1113 Budapest, |
| Bocskai út 134-146 |
| Hungary |

AstraZeneca Kft.

1113 Budapest,

Bocskai út 134-146

Hungary

Atacand

16 mg

Tablet

Oral anvendelse

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

4 mg

Tablet

Oral anvendelse

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

8 mg

Tablet

Oral anvendelse

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

16 mg

Tablet

Oral anvendelse

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22, |
| DK-2620 Albertslund, |
| Denmark |

AstraZeneca A/S

Roskildevej 22,

DK-2620 Albertslund,

Denmark

Atacand

32 mg

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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 4 mg

4 mg

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Irland

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Italien

| 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

Tablet

Oral anvendelse

Letland

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Letland

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Litauen

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

4 mg

Tablet

Oral anvendelse

Litauen

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Litauen

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Litauen

| AstraZeneca AB |
| --- |
| S-151 85 Södertälje, Sweden |

AstraZeneca AB

S-151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral anvendelse

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

2 mg

Tablet

Oral anvendelse

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

4 mg

Tablet

Oral anvendelse

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

8 mg

Tablet

Oral anvendelse

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

16 mg

Tablet

Oral anvendelse

Luxembourg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Bruxelles |
| Belgium |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Bruxelles

Belgium

Atacand

32 mg

Tablet

Oral anvendelse

Malta

| AstraZeneca AB, Gärtunavägen, |
| --- |
| S-15185, Södertälje, Sweden |

AstraZeneca AB, Gärtunavägen,

S-15185, Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Malta

| AstraZeneca AB, Gärtunavägen, |
| --- |
| S-15185, Södertälje, Sweden |

AstraZeneca AB, Gärtunavägen,

S-15185, Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Holland

| 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

Tablet

Oral anvendelse

Holland

| 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

Tablet

Oral anvendelse

Holland

| 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

Tablet

Oral anvendelse

Holland

| 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

Tablet

Oral anvendelse

Holland

| 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

Tablet

Oral anvendelse

Norge

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

4 mg

Tablet

Oral anvendelse

Norge

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

8 mg

Tablet

Oral anvendelse

Norge

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

16 mg

Tablet

Oral anvendelse

Norge

| AstraZeneca AS |
| --- |
| Boks 200 Vinderen |
| NO-0319 Oslo, Norway |

AstraZeneca AS

Boks 200 Vinderen

NO-0319 Oslo, Norway

Atacand

32 mg

Tablet

Oral anvendelse

Polen

| AstraZeneca AB, S-151 85 Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85 Södertälje

Gärtunavägen Sweden

Atacand

4 mg

Tablet

Oral anvendelse

Polen

| AstraZeneca AB, S-151 85 Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85 Södertälje

Gärtunavägen Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Polen

| AstraZeneca AB, S-151 85 Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85 Södertälje

Gärtunavägen Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Polen

| AstraZeneca AB, S-151 85 Södertälje |
| --- |
| Gärtunavägen Sweden |

AstraZeneca AB, S-151 85 Södertälje

Gärtunavägen Sweden

Atacand

32 mg

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Portugal

| 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

Tablet

Oral anvendelse

Rumænien

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 8 mg

8 mg

Tablet

Oral anvendelse

Rumænien

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 16 mg

16 mg

Tablet

Oral anvendelse

Rumænien

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 32 mg

32 mg

Tablet

Oral anvendelse

Slovakiet

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 8 mg

8 mg

Tablet

Oral anvendelse

Slovakiet

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 16 mg

16 mg

Tablet

Oral anvendelse

Slovakiet

| AstraZeneca AB, |
| --- |
| S 151 85, Södertälje, Sweden |

AstraZeneca AB,

S 151 85, Södertälje, Sweden

Atacand 32 mg

32 mg

Tablet

Oral anvendelse

Slovenien

| 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

Tablet

Oral anvendelse

Slovenien

| 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

Tablet

Oral anvendelse

Slovenien

| 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

Tablet

Oral anvendelse

Slovenien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Spanien

| 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

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

2 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

4 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

8 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

16 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Atacand

32 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

4 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

8 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

16 mg

Tablet

Oral anvendelse

Sverige

| AstraZeneca AB |
| --- |
| 151 85 Södertälje, Sweden |

AstraZeneca AB

151 85 Södertälje, Sweden

Racanda

32 mg

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

Storbritannien

| 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

Tablet

Oral anvendelse

---

BILAG X

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E) OG INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat EU/EØS | Indehaver af markedsføringstilladelse | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Pfizer Corporation Austria Ges.m.b.H. |
| Floridsdorfer Hauptstraße 1 |
| A - 1210 Wien Austria |

Medlemsstat EU/EØS

Indehaver af markedsføringstilladelse

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Pfizer Corporation Austria Ges.m.b.H.

Floridsdorfer Hauptstraße 1

A - 1210 Wien Austria

Sortis 10 mg - Filmtabletten

10 mg

Filmovertrukken tablet

Oral anvendelse

Østrig

| 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

Filmovertrukken tablet

Oral anvendelse

Østrig

| 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

Filmovertrukken tablet

Oral anvendelse

Østrig

| 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

Filmovertrukken tablet

Oral anvendelse

Belgien

| 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

Filmovertrukken tablet

Oral anvendelse

Belgien

| 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

Filmovertrukken tablet

Oral anvendelse

Belgien

| 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

Filmovertrukken tablet

Oral anvendelse

Belgien

| 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

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| 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

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| 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

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| 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

Filmovertrukken tablet

Oral anvendelse

Bulgarien

| 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

Filmovertrukken tablet

Oral anvendelse

Cypern

| 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

Filmovertrukken tablet

Oral anvendelse

Cypern

| 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

Filmovertrukken tablet

Oral anvendelse

Cypern

| 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

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| 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

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| 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

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| 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

Filmovertrukken tablet

Oral anvendelse

Tjekkiet

| 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

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, |
| 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8,

2750 Ballerup,

Denmark

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Danmark

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Estland

| 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

Filmovertrukken tablet

Oral anvendelse

Estland

| 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

Filmovertrukken tablet

Oral anvendelse

Estland

| 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

Filmovertrukken tablet

Oral anvendelse

Estland

| 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

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

10 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

20 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

40 mg

Filmovertrukken tablet

Oral anvendelse

Finland

| Pfizer Oy, |
| --- |
| Tietokuja 4, 00330 |
| Helsinki, Finland |

Pfizer Oy,

Tietokuja 4, 00330

Helsinki, Finland

Orbeos

80 mg

Filmovertrukken tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukken tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukken tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukken tablet

Oral anvendelse

Frankrig

| 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

80 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 10 mg

10 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 20 mg

20 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 40 mg

40 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Sortis 80 mg

80 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 10 mg

10 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 20 mg

20 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 40 mg

40 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Liprimar 80 mg

80 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 10 mg PD

10 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 20 mg PD

20 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 40 mg PD

40 mg

Filmovertrukken tablet

Oral anvendelse

Tyskland

| Pfizer Pharma GmbH, |
| --- |
| Linkstraße 10 10785 Berlin, |
| Germany |

Pfizer Pharma GmbH,

Linkstraße 10 10785 Berlin,

Germany

Atorvastatin 80 mg PD

80 mg

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Grækenland

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Ungarn

| 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

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

10 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

20 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

40 mg

Filmovertrukken tablet

Oral anvendelse

Island

| Pfizer ApS, |
| --- |
| Lautrupvang 8, 2750 Ballerup, |
| Denmark |

Pfizer ApS,

Lautrupvang 8, 2750 Ballerup,

Denmark

Zarator

80 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Irland

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Italien

| 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

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Letland

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent CT13 9NJ, United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Letland

| 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

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

10 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

20 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

40 mg

Filmovertrukken tablet

Oral anvendelse

Litauen

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

Pfizer Limited,

Ramsgate Road,

Sandwich, Kent, CT13 9NJ, United Kingdom

Sortis

80 mg

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| 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

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| 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

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| 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

Filmovertrukken tablet

Oral anvendelse

Luxembourg

| 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

Filmovertrukken tablet

Oral anvendelse

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

Filmovertrukken tablet

Oral anvendelse

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

Filmovertrukken tablet

Oral anvendelse

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

Filmovertrukken tablet

Oral anvendelse

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

Filmovertrukken tablet

Oral anvendelse

Holland

| 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

Filmovertrukken tablet

Oral anvendelse

Holland

| 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

Filmovertrukken tablet

Oral anvendelse

Holland

| 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

Filmovertrukken tablet

Oral anvendelse

Holland

| 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

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Norge

| Pfizer AS |
| --- |
| Pb. 3 |
| 1324 Lysaker |
| Norway |

Pfizer AS

Pb. 3

1324 Lysaker

Norway

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 10

10 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 20

20 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Parke-Davis GmbH, |
| --- |
| Pfizerstrasse 1, |
| 76 139 Karlsruhe, |
| Germany |

Parke-Davis GmbH,

Pfizerstrasse 1,

76 139 Karlsruhe,

Germany

Sortis 40

40 mg

Filmovertrukken tablet

Oral anvendelse

Polen

| Pfizer Polska Sp.z o.o. |
| --- |
| ul. Rzymowskiego 28 |
| 02-697 Warszawa |
| Poland |

Pfizer Polska Sp.z o.o.

ul. Rzymowskiego 28

02-697 Warszawa

Poland

Sortis 80

80 mg

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Portugal

| 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

Filmovertrukken tablet

Oral anvendelse

Rumænien

| 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

Filmovertrukken tablet

Oral anvendelse

Rumænien

| 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

Filmovertrukken tablet

Oral anvendelse

Rumænien

| 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

Filmovertrukken tablet

Oral anvendelse

Rumænien

| 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

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| 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

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| 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

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| 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

Filmovertrukken tablet

Oral anvendelse

Slovakiet

| 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

Filmovertrukken tablet

Oral anvendelse

Slovenien

| 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

Filmovertrukken tablet

Oral anvendelse

Slovenien

| 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

Filmovertrukken tablet

Oral anvendelse

Slovenien

| 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

Filmovertrukken tablet

Oral anvendelse

Slovenien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| 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

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

10 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

20 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

40 mg

Filmovertrukken tablet

Oral anvendelse

Spanien

| Almirall S.A. |
| --- |
| General Mitre, 151 |
| 08022 - Barcelona |
| Spain |

Almirall S.A.

General Mitre, 151

08022 - Barcelona

Spain

Prevencor

80 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Sverige

| Pfizer AB |
| --- |
| 191 90 Sollentuna |
| Sweden |

Pfizer AB

191 90 Sollentuna

Sweden

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Irland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Irland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

10 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

20 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin |
| Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin

Ireland

Lipitor

40 mg

Filmovertrukken tablet

Oral anvendelse

Storbritannien

| Pfizer Ireland Pharmaceuticals, |
| --- |
| Pottery Road, Dun Laoghaire, Co Dublin Ireland |

Pfizer Ireland Pharmaceuticals,

Pottery Road, Dun Laoghaire, Co Dublin Ireland

Lipitor

80 mg

Filmovertrukken tablet

Oral anvendelse

---

BILAG XI

FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉET OG INDLÆGSSEDLEN

Alle veterinærlægemidler til arter bestemt til fødevareproduktion, som indeholder de virksomme stoffer quinoloner og/eller fluoroquinoloner.

---

BILAG XII

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE

| Medlemsstat | Indehaver af markedsføringstilladelse | Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | AstraZeneca Österreich GmbH |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Østrig |

Medlemsstat

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Østrig

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Østrig

Seroquel XR 50 mg – Retardtabletten

50 mg

depottabletter

oral

Østrig

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Østrig |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Østrig

Seroquel XR 150 mg – Retardtabletten

150 mg

depottabletter

oral

Østrig

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Østrig |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Østrig

Seroquel XR 200 mg – Retardtabletten

200 mg

depottabletter

oral

Østrig

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Østrig |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Østrig

Seroquel XR 300 mg – Retardtabletten

300 mg

depottabletter

oral

Østrig

| AstraZeneca Österreich GmbH |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Østrig |

AstraZeneca Österreich GmbH

Schwarzenbergplatz 7

A-1037 Wien

Østrig

Seroquel XR 400 mg – Retardtabletten

400 mg

depottabletter

oral

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 50 mg – prolonged-release tablets

50 mg

depottabletter

oral

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 150 mg – prolonged-release tablets

150 mg

depottabletter

oral

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 200 mg – prolonged-release tablets

200 mg

depottabletter

oral

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 300 mg – prolonged-release tablets

300 mg

depottabletter

oral

Belgien

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 400 mg – prolonged-release tablets

400 mg

depottabletter

oral

Cypern

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| Storbritannien |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

Storbritannien

Seroquel XR 50 mg – prolonged-release tablets

50 mg

depottabletter

oral

Cypern

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| Storbritannien |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

Storbritannien

Seroquel XR 200 mg – prolonged-release tablets

200 mg

depottabletter

oral

Cypern

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| Storbritannien |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

Storbritannien

Seroquel XR 300 mg – prolonged-release tablets

300 mg

depottabletter

oral

Cypern

| AstraZeneca UK Limited, |
| --- |
| Silk Road Business Park, |
| Macclesfield, Cheshire, SK10 2NA, |
| Storbritannien |

AstraZeneca UK Limited,

Silk Road Business Park,

Macclesfield, Cheshire, SK10 2NA,

Storbritannien

Seroquel XR 400 mg – prolonged-release tablets

400 mg

depottabletter

oral

Tyskland

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Tyskland |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Tyskland

Seroquel Prolong 50 mg Retardtabletten

50 mg

depottabletter

oral

Tyskland

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Tyskland |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Tyskland

Seroquel Prolong 150 mg Retardtabletten

150 mg

depottabletter

oral

Tyskland

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Tyskland |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Tyskland

Seroquel Prolong 200 mg Retardtabletten

200 mg

depottabletter

oral

Tyskland

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Tyskland |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Tyskland

Seroquel Prolong 300 mg Retardtabletten

300 mg

depottabletter

oral

Tyskland

| AstraZeneca GmbH, |
| --- |
| Tinsdaler Weg 183, |
| 22880 Wedel, |
| Tyskland |

AstraZeneca GmbH,

Tinsdaler Weg 183,

22880 Wedel,

Tyskland

Seroquel Prolong 400 mg Retardtabletten

400 mg

depottabletter

oral

Denmark

| 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

depottabletter

oral

Denmark

| 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

depottabletter

oral

Denmark

| 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

depottabletter

oral

Denmark

| 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

depottabletter

oral

Denmark

| 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

depottabletter

oral

Grækenland

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Grækenland |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Grækenland

Seroquel XR 50 mg

50 mg

depottabletter

oral

Grækenland

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Grækenland |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Grækenland

Seroquel XR 150 mg

150 mg

depottabletter

oral

Grækenland

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Grækenland |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Grækenland

Seroquel XR 200 mg

200 mg

depottabletter

oral

Grækenland

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Grækenland |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Grækenland

Seroquel XR 300 mg

300 mg

depottabletter

oral

Grækenland

| AstraZeneca S.A. |
| --- |
| 4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens |
| Grækenland |

AstraZeneca S.A.

4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens

Grækenland

Seroquel XR 400 mg

400 mg

depottabletter

oral

Spanien

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spanien |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spanien

Seroquel Prolong 50 mg comprimidos de liberación prolongada

50 mg

depottabletter

oral

Spanien

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spanien |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spanien

Seroquel Prolong 150 mg comprimidos de liberación prolongada

150 mg

depottabletter

oral

Spanien

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spanien |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spanien

Seroquel Prolong 200 mg comprimidos de liberación prolongada

200 mg

depottabletter

oral

Spanien

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spanien |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spanien

Seroquel Prolong 300 mg comprimidos de liberación prolongada

300 mg

depottabletter

oral

Spanien

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache, 56 – Edificio Roble |
| 28033 Madrid |
| Spanien |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache, 56 – Edificio Roble

28033 Madrid

Spanien

Seroquel Prolong 400 mg comprimidos de liberación prolongada

400 mg

depottabletter

oral

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 50 mg depottabletti

50 mg

depottabletter

oral

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 150 mg depottabletti

150 mg

depottabletter

oral

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 200 mg depottabletti

200 mg

depottabletter

oral

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 300 mg depottabletti

300 mg

depottabletter

oral

Finland

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finland |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finland

Seroquel Prolong 400 mg depottabletti

400 mg

depottabletter

oral

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

50 mg

depottabletter

oral

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

150 mg

depottabletter

oral

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

200 mg

depottabletter

oral

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

300 mg

depottabletter

oral

Island

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Denmark |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Denmark

Seroquel Prolong

400 mg

depottabletter

oral

Irland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| Storbritannien |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

Storbritannien

Seroquel XR 50 mg prolonged-release tablets

50 mg

depottabletter

oral

Irland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| Storbritannien |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

Storbritannien

Seroquel XR 150 mg prolonged-release tablets

150 mg

depottabletter

oral

Irland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| Storbritannien |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

Storbritannien

Seroquel XR 200 mg prolonged-release tablets

200 mg

depottabletter

oral

Irland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| Storbritannien |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

Storbritannien

Seroquel XR 300 mg prolonged-release tablets

300 mg

depottabletter

oral

Irland

| AstraZeneca UK Ltd |
| --- |
| 600 Capability Green |
| Luton LU1 3LU |
| Storbritannien |

AstraZeneca UK Ltd

600 Capability Green

Luton LU1 3LU

Storbritannien

Seroquel XR 400 mg prolonged-release tablets

400 mg

depottabletter

oral

Luxemborg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 50 mg prolonged-release tablets

50 mg

depottabletter

oral

Luxemborg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 150 mg prolonged-release tablets

150 mg

depottabletter

oral

Luxemborg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 200 mg prolonged-release tablets

200 mg

depottabletter

oral

Luxemborg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 300 mg prolonged-release tablets

300 mg

depottabletter

oral

Luxemborg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| B-1180 Brussel |
| Belgien |

NV AstraZeneca SA

Egide Van Ophemstraat 110

B-1180 Brussel

Belgien

Seroquel XR 400 mg prolonged-release tablets

400 mg

depottabletter

oral

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| Storbritannien |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

Storbritannien

Seroquel XR 50 mg prolonged-release tablets

50 mg

depottabletter

oral

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| Storbritannien |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

Storbritannien

Seroquel XR 150 mg prolonged-release tablets

150 mg

depottabletter

oral

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| Storbritannien |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

Storbritannien

Seroquel XR 200 mg prolonged-release tablets

200 mg

depottabletter

oral

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| Storbritannien |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

Storbritannien

Seroquel XR 300 mg prolonged-release tablets

300 mg

depottabletter

oral

Malta

| AstraZeneca UK Ltd |
| --- |
| Silk Road Business Park |
| Macclesfield |
| Cheshire SK10 2NA |
| Storbritannien |

AstraZeneca UK Ltd

Silk Road Business Park

Macclesfield

Cheshire SK10 2NA

Storbritannien

Seroquel XR 400 mg prolonged-release tablets

400 mg

depottabletter

oral

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Seroquel XR 50 mg prolonged-release tablets

50 mg

depottabletter

oral

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Seroquel XR 150 mg prolonged-release tablets

150 mg

depottabletter

oral

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Seroquel XR 200 mg prolonged-release tablets

200 mg

depottabletter

oral

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Seroquel XR 300 mg prolonged-release tablets

300 mg

depottabletter

oral

Holland

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE Zoetermeer |
| Holland |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE Zoetermeer

Holland

Seroquel XR 400 mg prolonged-release tablets

400 mg

depottabletter

oral

Norge

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norge |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norge

Seroquel Depot 50 mg depottabletter

50 mg

depottabletter

oral

Norge

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norge |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norge

Seroquel Depot 150 mg depottabletter

150 mg

depottabletter

oral

Norge

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norge |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norge

Seroquel Depot 200 mg depottabletter

200 mg

depottabletter

oral

Norge

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norge |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norge

Seroquel Depot 300 mg depottabletter

300 mg

depottabletter

oral

Norge

| AstraZeneca AS, |
| --- |
| Hoffsveien 70B, |
| (PO Box 200), |
| 0319 Oslo, Norge |

AstraZeneca AS,

Hoffsveien 70B,

(PO Box 200),

0319 Oslo, Norge

Seroquel Depot 400 mg depottabletter

400 mg

depottabletter

oral

Polen

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, Storbritannien |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, Storbritannien

Seroquel XR

50 mg

depottabletter

oral

Polen

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, Storbritannien |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, Storbritannien

Seroquel XR

150 mg

depottabletter

oral

Polen

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, Storbritannien |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, Storbritannien

Seroquel XR

200 mg

depottabletter

oral

Polen

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, Storbritannien |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, Storbritannien

Seroquel XR

300 mg

depottabletter

oral

Polen

| AstraZeneca UK Limited, |
| --- |
| 15 Stanhope Gate, |
| London |
| W1K 1LN, Storbritannien |

AstraZeneca UK Limited,

15 Stanhope Gate,

London

W1K 1LN, Storbritannien

Seroquel XR

400 mg

depottabletter

oral

Portugal

| 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

depottabletter

oral

Portugal

| 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

depottabletter

oral

Portugal

| 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

depottabletter

oral

Portugal

| 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

depottabletter

oral

Portugal

| 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

depottabletter

oral

Sverige

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sverige |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sverige

Seroquel Depot 50 mg depottabletter

50 mg

depottabletter

oral

Sverige

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sverige |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sverige

Seroquel Depot 150 mg depottabletter

150 mg

depottabletter

oral

Sverige

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sverige |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sverige

Seroquel Depot 200 mg depottabletter

200 mg

depottabletter

oral

Sverige

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sverige |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sverige

Seroquel Depot 300 mg depottabletter

300 mg

depottabletter

oral

Sverige

| AstraZeneca AB |
| --- |
| AstraZeneca Sverige |
| SE-151 85 Södertälje |
| Sverige |

AstraZeneca AB

AstraZeneca Sverige

SE-151 85 Södertälje

Sverige

Seroquel Depot 400 mg depottabletter

400 mg

depottabletter

oral

---

BILAG XIII

LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKER, DYREART, INDGIVELSESVEJ OG INDEHAVERE AFMARKEDSFØRINGSTILLADELSEI MEDLEMSSTATEN

| Medlemsstat/EEA | Indehaver af markedsføringstilladelsen | Særnavn | Lægemiddelform | Styrke | Dyrearter | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- | --- |
| Østrig | Novartis Animal Health GmbH., |
| Biochemiestrasse 10, |
| 6250 Kundl |
| AUSTRIA |

Medlemsstat/EEA

Indehaver af markedsføringstilladelsen

Særnavn

Lægemiddelform

Styrke

Dyrearter

Indgivelsesvej

Østrig

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

Grise

Oral anvendelse

Østrig

| 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

Grise

Oral anvendelse

Østrig

| 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

Grise

Oral anvendelse

Belgien

| 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

Grise

Oral anvendelse

Cypern

| Novartis Animal Health Inc., |
| --- |
| Basle, |
| SWITZERLAND |

Novartis Animal Health Inc.,

Basle,

SWITZERLAND

Denagard 10 %

Premix

100 mg/g

Grise

Oral anvendelse

Tjekkiet

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Tjekkiet

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Frankrig

| 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

Grise

Kalkuner

Kyllinger

Oral anvendelse

Frankrig

| 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

Kaniner

Grise

Oral anvendelse

Tyskland

| Novartis Tiergesundheit GmbH |
| --- |
| Zielstattstr. 40, |
| 81379 München |
| GERMANY |

Novartis Tiergesundheit GmbH

Zielstattstr. 40,

81379 München

GERMANY

Denagard 10 % AMV

Premix

100 g/kg

Grise

Oral anvendelse

Grækenland

| 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

Grise

Oral anvendelse

Grækenland

| 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

Grise

Oral anvendelse

Ungarn

| 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

Grise

Oral anvendelse

Irland

| 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

Grise

Oral anvendelse

Irland

| 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

Grise

Oral anvendelse

Italien

| 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

Grise

Kyllinger

Oral anvendelse

Italien

| 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

Grise

Oral anvendelse

Letland

| 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

Grise

Oral anvendelse

Litauen

| 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

Grise

Oral anvendelse

Portugal

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Portugal

| 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

Grise

Kyllinger

Kalkuner

Kaniner

Oral anvendelse

Portugal

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Polen

| 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

Grise

Oral anvendelse

Polen

| 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

Grise

Oral anvendelse

Rumænien

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Rumænien

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Slovakiet

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Slovakiet

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Spanien

| 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

Grise

Kyllinger

Kalkuner

Kaniner

Oral anvendelse

Spanien

| 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

Grise

Kaniner

Oral anvendelse

Spanien

| 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

Grise

Kyllinger

Kalkuner

Oral anvendelse

Sverige

| 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

Grise

Oral anvendelse

Nederlandene

| 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

Grise

Oral anvendelse

Nederlandene

| 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

Grise

Oral anvendelse

Det Forenede Kongerige

| 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

Grise

Oral anvendelse

Det Forenede Kongerige

| 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

Grise

Oral anvendelse

Det Forenede Kongerige

| 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

Grise

Oral anvendelse

---

BILAG XIV

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat EU/EEA | Indehaver af markedsføringstilladelsen | Ansøger | (Handels) navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- | --- |
| Belgien | | IDL, 36 avenue Hoche, |
| 75008 Paris. FRANKRIG |

Medlemsstat EU/EEA

Indehaver af markedsføringstilladelsen

Ansøger

(Handels) navn

Styrke

Lægemiddelform

Indgivelsesvej

Belgien

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 25 mg

25 mg

kapsel

oral anvendelse

Belgien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 50 mg

50 mg

kapsel

oral anvendelse

Belgien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 100 mg

100 mg

kapsel

oral anvendelse

Tyskland

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 25 mg

25 mg

kapsel

oral anvendelse

Tyskland

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 50 mg

50 mg

kapsel

oral anvendelse

Tyskland

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 100 mg

100 mg

kapsel

oral anvendelse

Italien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporina IDL 25 mg

25 mg

kapsel

oral anvendelse

Italien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporina IDL 50 mg

50 mg

kapsel

oral anvendelse

Italien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporina IDL 100 mg

100 mg

kapsel

oral anvendelse

Nederlandene

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche

75008 Paris. FRANKRIG

Ciclosporin IDL 25 mg

25 mg

kapsel, blød

oral anvendelse

Nederlandene

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche

75008 Paris. FRANKRIG

Ciclosporin IDL 50 mg

50 mg

kapsel, blød

oral anvendelse

Nederlandene

| IDL, 36 avenue Hoche |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche

75008 Paris. FRANKRIG

Ciclosporin IDL 100 mg

100 mg

kapsel, blød

oral anvendelse

Spanien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporina IDL 25 mg

25 mg

kapsel

oral anvendelse

Spanien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporina IDL 50 mg

50 mg

kapsel

oral anvendelse

Spanien

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporina IDL 100 mg

100 mg

kapsel

oral anvendelse

Sverige

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciklosporin IDL 25 mg

25 mg

kapsel

oral anvendelse

Sverige

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciklosporin IDL 50 mg

50 mg

kapsel

oral anvendelse

Sverige

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciklosporin IDL 100 mg

100 mg

kapsel

oral anvendelse

Det Forenede Kongerige

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 25 mg

25 mg

kapsel

oral anvendelse

Det Forenede Kongerige

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 50 mg

50 mg

kapsel

oral anvendelse

Det Forenede Kongerige

| IDL, 36 avenue Hoche, |
| --- |
| 75008 Paris. FRANKRIG |

IDL, 36 avenue Hoche,

75008 Paris. FRANKRIG

Ciclosporin IDL 100 mg

100 mg

kapsel

oral anvendelse

---

BILAG XV

LISTE OVERSÆRNAVNE, LÆGEMIDDELFORM, STYRKER AF LÆGEMIDMLET, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSEN I MEDLEMSLANDENE (EU/EØS)

| Medlemsland EU/EØS | Indehaver af markedsføringstilladelsen | Særnavn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Abbott GmbH |
| Perfektastraße 84A |
| A-1230 Wien |
| Østrig |

Medlemsland EU/EØS

Indehaver af markedsføringstilladelsen

Særnavn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Abbott GmbH

Perfektastraße 84A

A-1230 Wien

Østrig

Reductil 10 mg - Hartkapseln

10 mg

Kapsel, hård

oral anvendelse

Østrig

| Abott GmbH |
| --- |
| Perfektastraße 84A |
| A-1230 Wien |
| Østrig |

Abott GmbH

Perfektastraße 84A

A-1230 Wien

Østrig

Reductil 15 mg - Hartkapseln

15 mg

Kapsel, hård

oral anvendelse

Østrig

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Holland

Sibutramin Teva 10 mg Kapseln

10 mg

Kapsel, hård

oral anvendelse

Østrig

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Holland

Sibutramin Teva 15 mg Kapseln

15 mg

Kapsel, hård

oral anvendelse

Belgien

| Abbott SA |
| --- |
| rue du Bosquet 2 |
| 1348 Ottignies/LLN |
| Belgien |

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belgien

Reductil 10 mg

10 mg

Kapsel, hård

oral anvendelse

Belgien

| Abbott SA |
| --- |
| rue du Bosquet 2 |
| 1348 Ottignies/LLN |
| Belgien |

Abbott SA

rue du Bosquet 2

1348 Ottignies/LLN

Belgien

Reductil 15 mg

15 mg

Kapsel, hård

oral anvendelse

Belgien

| Sandoz NV |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgien |

Sandoz NV

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgien

Sibutramin Sandoz 10 mg

10 mg

Kapsel, hård

oral anvendelse

Belgien

| Sandoz NV |
| --- |
| Telecom Gardens |
| Medialaan 40 |
| 1800 Vilvoorde |
| Belgien |

Sandoz NV

Telecom Gardens

Medialaan 40

1800 Vilvoorde

Belgien

Sibutramin Sandoz 15 mg

15 mg

Kapsel, hård

oral anvendelse

Belgien

| Teva pharma belgium |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgien |

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belgien

Sibutramin Teva 10 mg

10 mg

Kapsel, hård

oral anvendelse

Belgien

| Teva pharma belgium |
| --- |
| Laarstraat 16 |
| 2610 Wilrijk |
| Belgien |

Teva pharma belgium

Laarstraat 16

2610 Wilrijk

Belgien

Sibutramin Teva 15 mg

15 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Abbott GmbH & Co KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil

10 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Abbott GmbH & Co KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil

15 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Sandoz d.d., |
| --- |
| Verovskova 57 |
| SI - 1000 Ljubljana |
| Slovenien |

Sandoz d.d.,

Verovskova 57

SI - 1000 Ljubljana

Slovenien

Sibutramin Sandoz

10 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| SI - 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

SI - 1000 Ljubljana

Slovenien

Sibutramin Sandoz

15 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Den Tjekkiske republik |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Den Tjekkiske republik

Lindaxa

10 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Zentiva k.s. |
| --- |
| U kabelovny 130 |
| 102 37 Prague 10 |
| Den Tjekkiske republik |

Zentiva k.s.

U kabelovny 130

102 37 Prague 10

Den Tjekkiske republik

Lindaxa

15 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V. Gogol str. |
| Sredetz district |
| 1124 Sofia |
| Bulgarien |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgarien

Meissa

10 mg

Kapsel, hård

oral anvendelse

Bulgarien

| Teva Pharmaceuticals Bulgaria EOOD |
| --- |
| 15 N.V. Gogol str. |
| Sredetz district |
| 1124 Sofia |
| Bulgarien |

Teva Pharmaceuticals Bulgaria EOOD

15 N.V. Gogol str.

Sredetz district

1124 Sofia

Bulgarien

Meissa

15 mg

Kapsel, hård

oral anvendelse

Den Tjekkiske republik

| Abbott GmbH &Co.KG |
| --- |
| Max-Planck-Ring-2 |
| 65202 Wiesbaden |
| Tyskland |

Abbott GmbH &Co.KG

Max-Planck-Ring-2

65202 Wiesbaden

Tyskland

MERIDIA 10 MG

10 mg

Kapsel, hård

oral anvendelse

Den Tjekkiske republik

| Abbott GmbH &Co.KG |
| --- |
| Max-Planck-Ring-2 |
| 65202 Wiesbaden |
| Tyskland |

Abbott GmbH &Co.KG

Max-Planck-Ring-2

65202 Wiesbaden

Tyskland

MERIDIA 15 MG

15 mg

Kapsel, hård

oral anvendelse

Den Tjekkiske republik

| Zentiva, k.s. |
| --- |
| U kabelovny 130, 102 37 |
| Prague 10 |
| Den Tjekkiske republik |

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Den Tjekkiske republik

LINDAXA 10

10 mg

Kapsel, hård

oral anvendelse

Den Tjekkiske republik

| Zentiva, k.s. |
| --- |
| U kabelovny 130, 102 37 |
| Prague 10 |
| Den Tjekkiske republik |

Zentiva, k.s.

U kabelovny 130, 102 37

Prague 10

Den Tjekkiske republik

LINDAXA 15

15 mg

Kapsel, hård

oral anvendelse

Den Tjekkiske republik

| TEVA Pharmaceuticals ČR, s.r.o. |
| --- |
| Radlická 3185/Ic |
| 150 00 Prague 5 |
| Den Tjekkiske republik |

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Den Tjekkiske republik

SIBUTRAMIN-TEVA 10 MG TOBOLKY

10 mg

Kapsel, hård

oral anvendelse

Den Tjekkiske republik

| TEVA Pharmaceuticals ČR, s.r.o. |
| --- |
| Radlická 3185/Ic |
| 150 00 Prague 5 |
| Den Tjekkiske republik |

TEVA Pharmaceuticals ČR, s.r.o.

Radlická 3185/Ic

150 00 Prague 5

Den Tjekkiske republik

SIBUTRAMIN-TEVA 15 MG TOBOLKY

15 mg

Kapsel, hård

oral anvendelse

Danmark

| Abbott Scandinavia AB |
| --- |
| Postboks 509 |
| SE-169 29, Solna |
| Sverige |

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Sverige

Reductil

10 mg

Kapsel, hård

oral anvendelse

Danmark

| Abbott Scandinavia AB |
| --- |
| Postboks 509 |
| SE-169 29, Solna |
| Sverige |

Abbott Scandinavia AB

Postboks 509

SE-169 29, Solna

Sverige

Reductil

15 mg

Kapsel, hård

oral anvendelse

Danmark

| 1A Farma A/S |
| --- |
| Herstedøstervej 27-29 |
| DK-2620 Albertslund |
| Danmark |

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Danmark

Sibutramin »1A Farma«

10 mg

Kapsel, hård

oral anvendelse

Danmark

| 1A Farma A/S |
| --- |
| Herstedøstervej 27-29 |
| DK-2620 Albertslund |
| Danmark |

1A Farma A/S

Herstedøstervej 27-29

DK-2620 Albertslund

Danmark

Sibutramin »1A Farma«

15 mg

Kapsel, hård

oral anvendelse

Danmark

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C. F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Sibutramin »Sandoz«

10 mg

Kapsel, hård

oral anvendelse

Danmark

| Sandoz A/S |
| --- |
| C. F. Tietgens Boulevard 40 |
| DK-5220 Odense SØ |
| Danmark |

Sandoz A/S

C. F. Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Sibutramin »Sandoz«

15 mg

Kapsel, hård

oral anvendelse

Danmark

| Teva Danmark A/S |
| --- |
| Østergade 38 |
| DK-1100 København K |
| Danmark |

Teva Danmark A/S

Østergade 38

DK-1100 København K

Danmark

Sibutramin »Teva«

10 mg

Kapsel, hård

oral anvendelse

Danmark

| Teva Danmark A/S |
| --- |
| Østergade 38 |
| DK-1100 København K |
| Danmark |

Teva Danmark A/S

Østergade 38

DK-1100 København K

Danmark

Sibutramin »Teva«

15 mg

Kapsel, hård

oral anvendelse

Estland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

REDUCTIL

10 mg

Kapsel, hård

oral anvendelse

Estland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

REDUCTIL

15 mg

Kapsel, hård

oral anvendelse

Estland

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenien

SIBUTRIL

10 mg

Kapsel, hård

oral anvendelse

Estland

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenien

SIBUTRIL

15 mg

Kapsel, hård

oral anvendelse

Estland

| Zentiva, k.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| Den Tjekkiske republik |

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Den Tjekkiske republik

LINDAXA 10

10 mg

Kapsel, hård

oral anvendelse

Estland

| Zentiva, k.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Prague 10 |
| Den Tjekkiske republik |

Zentiva, k.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Prague 10

Den Tjekkiske republik

LINDAXA 15

15 mg

Kapsel, hård

oral anvendelse

Estland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Holland

SIBUTRAMINE TEVA

10 mg

Kapsel, hård

oral anvendelse

Estland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Holland

SIBUTRAMINE TEVA

15 mg

Kapsel, hård

oral anvendelse

Finland

| Abbott Scandinavia AB |
| --- |
| P.O. Box 509 |
| 16929 Solna |
| Sverige |

Abbott Scandinavia AB

P.O. Box 509

16929 Solna

Sverige

Reductil

10 mg, 15 mg

Kapsel, hård

oral anvendelse

Finland

| Sandoz A/S C.F. |
| --- |
| Tietgens Boulevard 40 |
| 5220 Odense SØ |
| Danmark |

Sandoz A/S C.F.

Tietgens Boulevard 40

5220 Odense SØ

Danmark

Sibutramin Sandoz

10 mg, 15 mg

Kapsel, hård

oral anvendelse

Finland

| Teva Sweden AB |
| --- |
| Järnvägsgatan 11 |
| Box 1070 |
| 25110 Helsingborg |
| Sverige |

Teva Sweden AB

Järnvägsgatan 11

Box 1070

25110 Helsingborg

Sverige

Sibutramine Teva

10 mg, 15 mg

Kapsel, hård

oral anvendelse

Frankrig

| ABBOT France |
| --- |
| 10, RUE D'ARCUEIL |
| SILIC 233 |
| 94528 RUNGIS CEDEX |
| FRANKRIG |

ABBOT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

FRANKRIG

SIBUTRAL 10 mg, gélule

10 mg

Kapsel, hård

oral anvendelse

Frankrig

| ABBOT France |
| --- |
| 10, RUE D'ARCUEIL |
| SILIC 233 |
| 94528 RUNGIS CEDEX |
| FRANKRIG |

ABBOT France

10, RUE D'ARCUEIL

SILIC 233

94528 RUNGIS CEDEX

FRANKRIG

SIBUTRAL 15 mg, gélule

15 mg

Kapsel, hård

oral anvendelse

Tyskland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil 10 mg Hartkapseln

10 mg

Kapsel, hård

oral anvendelse

Tyskland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil 15 mg Hartkapseln

15 mg

Kapsel, hård

oral anvendelse

Tyskland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Zelium 10 mg Hartkapseln

10 mg

Kapsel, hård

oral anvendelse

Tyskland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Zelium 15 mg Hartkapseln

15 mg

Kapsel, hård

oral anvendelse

Tyskland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reduxade 10 mg Hartkapseln

10 mg

Kapsel, hård

oral anvendelse

Tyskland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reduxade 15 mg Hartkapseln

15 mg

Kapsel, hård

oral anvendelse

Tyskland

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Tyskland |

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Tyskland

Sibutramin - 1A Pharma 10 mg Hartkapseln

10 mg

Kapsel, hård

oral anvendelse

Tyskland

| 1 A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Tyskland |

1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Tyskland

Sibutramin - 1A Pharma 15 mg Hartkapseln

15 mg

Kapsel, hård

oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

83602 Holzkirchen

Tyskland

Sibutramin-HEXAL 10 mg Hartkapseln

10 mg

Kapsel, hård

oral anvendelse

Tyskland

| HEXAL AG |
| --- |
| Postfach 1263 |
| 83602 Holzkirchen |
| Tyskland |

HEXAL AG

Postfach 1263

83602 Holzkirchen

Tyskland

Sibutramin-HEXAL 15 mg Hartkapseln

15 mg

Kapsel, hård

oral anvendelse

Grækenland

| Abbott Laboratories (Hellas) S.A. |
| --- |
| 512, Vouliagmenis Avenue |
| GR 17456, Alimos |
| Athens |
| Grækenland |

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Athens

Grækenland

Reductil

10 mg

Kapsel, hård

oral anvendelse

Grækenland

| Abbott Laboratories (Hellas) S.A. |
| --- |
| 512, Vouliagmenis Avenue |
| GR 17456, Alimos |
| Athens |
| Grækenland |

Abbott Laboratories (Hellas) S.A.

512, Vouliagmenis Avenue

GR 17456, Alimos

Athens

Grækenland

Reductil

15 mg

Kapsel, hård

oral anvendelse

Grækenland

| Teva Pharmaceuticals Europe B.V. |
| --- |
| European Headquarters |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

Holland

Sibutramine/Teva

10 mg

Kapsel, hård

oral anvendelse

Grækenland

| Teva Pharmaceuticals Europe B.V. |
| --- |
| European Headquarters |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharmaceuticals Europe B.V.

European Headquarters

Computerweg 10

3542 DR Utrecht

Holland

Sibutramine/Teva

15 mg

Kapsel, hård

oral anvendelse

Ungarn

| Zentiva k. s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Den Tjekkiske republik |

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Den Tjekkiske republik

LINDAXA

10 mg

Kapsel, hård

oral anvendelse

Ungarn

| Zentiva k. s. |
| --- |
| U Kabelovny 130 |
| 102 37 Praha 10 |
| Den Tjekkiske republik |

Zentiva k. s.

U Kabelovny 130

102 37 Praha 10

Den Tjekkiske republik

LINDAXA

15 mg

Kapsel, hård

oral anvendelse

Ungarn

| Teva Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Ungarn |

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Ungarn

MINIMECTIL

10 mg

Kapsel, hård

oral anvendelse

Ungarn

| Teva Magyarország zrt. |
| --- |
| Rákóczi út 70-72. |
| 1074 Budapest |
| Ungarn |

Teva Magyarország zrt.

Rákóczi út 70-72.

1074 Budapest

Ungarn

MINIMECTIL

15 mg

Kapsel, hård

oral anvendelse

Ungarn

| Abbott Laboratories Kft. |
| --- |
| Teve u. 1/a-c |
| 1139 Budapest |
| Hungary |

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Hungary

REDUCTIL

10 mg

Kapsel, hård

oral anvendelse

Ungarn

| Abbott Laboratories Kft. |
| --- |
| Teve u. 1/a-c |
| 1139 Budapest |
| Ungarn |

Abbott Laboratories Kft.

Teve u. 1/a-c

1139 Budapest

Ungarn

REDUCTIL

15 mg

Kapsel, hård

oral anvendelse

Island

| Abbott Scandinavia |
| --- |
| Gårdsvägen 8 |
| Box 5091 |
| SE-169 29 Solna |
| Sverige |

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Sverige

Reductil

10 mg

Kapsel, hård

oral anvendelse

Island

| Abbott Scandinavia |
| --- |
| Gårdsvägen 8 |
| Box 5091 |
| SE-169 29 Solna |
| Sverige |

Abbott Scandinavia

Gårdsvägen 8

Box 5091

SE-169 29 Solna

Sverige

Reductil

15 mg

Kapsel, hård

oral anvendelse

Irland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 Dr Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Holland

Sibutramine Teva 10 mg Capsules

10 mg

Kapsel, hård

oral anvendelse

Irland

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 Dr Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 Dr Utrecht

Holland

Sibutramine Teva 15 mg Capsules

15 mg

Kapsel, hård

oral anvendelse

Irland

| Abbott Laboratories Ireland Ltd |
| --- |
| 4051 Kingswood Drive |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Abbott Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Irland

Reductil 10 mg capsules, hard

10 mg

Kapsel, hård

oral anvendelse

Irland

| Abbott Laboratories Ireland Ltd |
| --- |
| 4051 Kingswood Drive |
| Citywest Business Campus |
| Dublin 24 |
| Irland |

Abbott Laboratories Ireland Ltd

4051 Kingswood Drive

Citywest Business Campus

Dublin 24

Irland

Reductil 15 mg capsules, hard

15 mg

Kapsel, hård

oral anvendelse

Irland

| Rowex Ltd |
| --- |
| Bantry |
| Co.Cork |
| Irland |

Rowex Ltd

Bantry

Co.Cork

Irland

Sitrane 10 mg hard capsules

10 mg

Kapsel, hård

oral anvendelse

Irland

| Rowex Ltd |
| --- |
| Bantry |
| Co.Cork |
| Irland |

Rowex Ltd

Bantry

Co.Cork

Irland

Sitrane 15 mg hard capsules

15 mg

Kapsel, hård

oral anvendelse

Italien

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italien |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italien

REDUXATE

10 mg

Kapsel

oral anvendelse

Italien

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italien |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italien

REDUXATE

15 mg

Kapsel

oral anvendelse

Italien

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italien |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italien

ECTIVA

10 mg

Kapsel

oral anvendelse

Italien

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italien |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italien

ECTIVA

15 mg

Kapsel

oral anvendelse

Italien

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italien |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italien

REDUCTIL

10 mg

Kapsel

oral anvendelse

Italien

| ABBOTT srl |
| --- |
| Via Pontina Km 52 |
| 04010 Campoverde di Aprilia |
| Italien |

ABBOTT srl

Via Pontina Km 52

04010 Campoverde di Aprilia

Italien

REDUCTIL

15 mg

Kapsel

oral anvendelse

Letland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil 15 mg hard capsules

15 mg

Kapsel, hård

oral anvendelse

Letland

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil 10 mg hard capsules

10 mg

Kapsel, hård

oral anvendelse

Letland

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenien

Sibutril 15 mg capsules, hard

15 mg

Kapsel, hård

oral

Letland

| Sandoz d.d. |
| --- |
| Verovškova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovškova 57

1000 Ljubljana

Slovenien

Sibutril 10 mg capsules, hard

10 mg

Kapsel, hård

oral

Litauen

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil

10 mg

Kapsel, hård

oral anvendelse

Litauen

| Abbott GmbH & Co. KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co. KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

Reductil

15 mg

Kapsel, hård

oral anvendelse

Litauen

| Zentiva k. s. |
| --- |
| U kabelovny 130 |
| 10237 Prague 10 Dolni Mecholupy Den Tjekkiske republik |

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Den Tjekkiske republik

Lindaxa

10 mg

Kapsel, hård

oral anvendelse

Litauen

| Zentiva k. s. |
| --- |
| U kabelovny 130 |
| 10237 Prague 10 Dolni Mecholupy Den Tjekkiske republik |

Zentiva k. s.

U kabelovny 130

10237 Prague 10 Dolni Mecholupy Den Tjekkiske republik

Lindaxa

15 mg

Kapsel, hård

oral anvendelse

Litauen

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenien

Sibutril

10 mg

Kapsel, hård

oral anvendelse

Litauen

| Sandoz d.d. |
| --- |
| Verovskova 57 |
| 1000 Ljubljana |
| Slovenien |

Sandoz d.d.

Verovskova 57

1000 Ljubljana

Slovenien

Sibutril

15 mg

Kapsel, hård

oral anvendelse

Litauen

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Holland

Sibutramine Teva

10 mg

Kapsel, hård

oral anvendelse

Litauen

| Teva Pharma B.V. |
| --- |
| Computerweg 10 |
| 3542 DR Utrecht |
| Holland |

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Holland

Sibutramine Teva

15 mg

Kapsel, hård

oral anvendelse

Luxembourg

| Abbott Laboratoires |
| --- |
| 2, rue du Bosquet |
| B- 1348 Ottignies L.L.N. |
| Belgien |

Abbott Laboratoires

2, rue du Bosquet

B- 1348 Ottignies L.L.N.

Belgien

Reductil

10 mg

Kapsel

oral anvendelse

Luxembourg

| Abbott Laboratoires |
| --- |
| 2, rue du Bosquet |
| B- 1348 Ottignies L.L.N. |
| Belgien |

Abbott Laboratoires

2, rue du Bosquet

B- 1348 Ottignies L.L.N.

Belgien

Reductil

15 mg

Kapsler

oral anvendelse

Malta

| Abbott Laboratories Limited Queenborough |
| --- |
| Kent |
| ME11 5EL |
| Storbritannien |

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

Storbritannien

Reductil

10 mg

Kapsel, hård

oral anvendelse

Malta

| Abbott Laboratories Limited Queenborough |
| --- |
| Kent |
| ME11 5EL |
| Storbritannien |

Abbott Laboratories Limited Queenborough

Kent

ME11 5EL

Storbritannien

Reductil

15 mg

Kapsel, hård

oral anvendelse

Holland

| Abbott B.V. |
| --- |
| Siriusdreef 51 |
| 2132 WT, Hoofddorp |
| Holland |

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Holland

Reductil 10 mg, capsules, hard

10 mg

Kapsel, hård

oral anvendelse

Holland

| Abbott B.V. |
| --- |
| Siriusdreef 51 |
| 2132 WT, Hoofddorp |
| Holland |

Abbott B.V.

Siriusdreef 51

2132 WT, Hoofddorp

Holland

Reductil 15 mg, capsules, hard

15 mg

Kapsel, hård

oral anvendelse

Holland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH, Almere |
| Holland |

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Holland

Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules

10 mg

Kapsel, hård

oral anvendelse

Holland

| Sandoz B.V. |
| --- |
| Veluwezoom 22 |
| 1327 AH, Almere |
| Holland |

Sandoz B.V.

Veluwezoom 22

1327 AH, Almere

Holland

Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules

15 mg

Kapsel, hård

oral anvendelse

Holland

| Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 |
| --- |
| 8226 JX, Lelystad |
| Holland |

Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144

8226 JX, Lelystad

Holland

Reductil 15 mg, capsules

15 mg

Kapsel, hård

oral anvendelse

Holland

| Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144 |
| --- |
| 8226 JX, Lelystad |
| Holland |

Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144

8226 JX, Lelystad

Holland

Reductil 10 mg, capsules

10 mg

Kapsel, hård

oral anvendelse

Holland

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA, Haarlem |
| Holland |

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Holland

Sibutramine HCL- monohydraat 10 mg PCH, capsules

10 mg

Kapsel, hård

oral anvendelse

Holland

| Pharmachemie B.V. |
| --- |
| Swensweg 5 |
| 2031 GA, Haarlem |
| Holland |

Pharmachemie B.V.

Swensweg 5

2031 GA, Haarlem

Holland

Sibutramine HCL- monohydraat 15 mg PCH, capsules

15 mg

Kapsel, hård

oral anvendelse

Norge

| Abbot Scandinavia |
| --- |
| AB Box 509 |
| 169 29 Solna |
| Sverige |

Abbot Scandinavia

AB Box 509

169 29 Solna

Sverige

REDUCTIL

10 mg

Kapsel, hård

oral anvendelse

Norge

| Abbot Scandinavia |
| --- |
| AB Box 509 |
| 169 29 Solna |
| Sverige |

Abbot Scandinavia

AB Box 509

169 29 Solna

Sverige

REDUCTIL

15 mg

Kapsel, hård

oral anvendelse

Norge

| Euromedica Norge AS |
| --- |
| Jerikoveien 28 C |
| 1067 Oslo |
| Norge |

Euromedica Norge AS

Jerikoveien 28 C

1067 Oslo

Norge

REDUCTIL

10 mg

Kapsel, hård

oral anvendelse

Norge

| Euromedica Norge AS |
| --- |
| Jerikoveien 28 C |
| 1067 Oslo |
| Noge |

Euromedica Norge AS

Jerikoveien 28 C

1067 Oslo

Noge

REDUCTIL

15 mg

Kapsel, hård

oral anvendelse

Norge

| Sandoz A/ |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 København S |
| Danmark |

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danmark

SIBUTRAMIN SANDOZ

10 mg

Kapsel, hård

oral anvendelse

Norge

| Sandoz A/ |
| --- |
| Edvard Thomsens Vej 14 |
| 2300 København S |
| Danmark |

Sandoz A/

Edvard Thomsens Vej 14

2300 København S

Danmark

SIBUTRAMIN SANDOZ

15 mg

Kapsel, hård

oral anvendelse

Polen

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| 53 Emilii Plater St. |
| 00-113 Warsaw |
| Polen |

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Polen

Afibron

10 mg

Kapsel, hård

oral anvendelse

Polen

| Teva Pharmaceuticals Polska Sp. z o.o. |
| --- |
| 53 Emilii Plater St. |
| 00-113 Warsaw |
| Polen |

Teva Pharmaceuticals Polska Sp. z o.o.

53 Emilii Plater St.

00-113 Warsaw

Polen

Afibron

15 mg

Kapsel, hård

oral anvendelse

Polen

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Praha 10 |
| Den Tjekkiske republik |

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Den Tjekkiske republik

Lindaxa 10

10 mg

Kapsel, hård

oral anvendelse

Polen

| Zentiva a.s. |
| --- |
| U Kabelovny 130 |
| Dolni Mecholupy |
| 102 37 Praha 10 |
| Den Tjekkiske republik |

Zentiva a.s.

U Kabelovny 130

Dolni Mecholupy

102 37 Praha 10

Den Tjekkiske republik

Lindaxa 15

15 mg

Kapsel, hård

oral anvendelse

Polen

| Abbott Laboratories Poland Sp. z o. o. |
| --- |
| ul. Postępu 18A |
| 02-676 Warsaw |
| Polen |

Abbott Laboratories Poland Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Polen

Meridia 10

10 mg

Kapsel, hård

oral anvendelse

Polen

| Abbott Laboratories Poland Sp. z o. o. |
| --- |
| ul. Postępu 18A |
| 02-676 Warsaw |
| Polen |

Abbott Laboratories Poland Sp. z o. o.

ul. Postępu 18A

02-676 Warsaw

Polen

Meridia 15

15 mg

Kapsel, hård

oral anvendelse

Polen

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Østrig |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Østrig

Obesan

10 mg

Kapsel, hård

oral anvendelse

Polen

| Sandoz GmbH |
| --- |
| Biochemiestrasse 10 |
| A-6250 Kundl |
| Østrig |

Sandoz GmbH

Biochemiestrasse 10

A-6250 Kundl

Østrig

Obesan

15 mg

Kapsel, hård

oral anvendelse

Polen

| 1A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Sibutramine-1A Pharma

10 mg

Kapsel, hård

oral anvendelse

Polen

| 1A Pharma GmbH |
| --- |
| Keltenring 1 + 3 |
| 82041 Oberhaching |
| Tyskland |

1A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Tyskland

Sibutramine-1A Pharma

15 mg

Kapsel, hård

oral anvendelse

Polen

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198 |
| Poznan |
| Polen |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Polen

Zelixa

10 mg

Filmovertrukentablet

oral anvendelse

Polen

| Biofarm Sp. z o.o. |
| --- |
| Wałbrzyska 13, 60-198 |
| Poznan |
| Polen |

Biofarm Sp. z o.o.

Wałbrzyska 13, 60-198

Poznan

Polen

Zelixa

15 mg

Filmovertrukentablet

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no 2 -Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 -Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

10 mg

Kapsel, hård

oral anvendelse

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no 2 Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Egostar

15 mg

Kapsel, hård

oral anvendelse

Portugal

| Pentafarma - Sociedade Técnico-Medicinal, S.A. |
| --- |
| Rua da Tapada Grande, no 2 Abrunheira |
| 2710-089 Sintra |
| Portugal |

Pentafarma - Sociedade Técnico-Medicinal, S.A.

Rua da Tapada Grande, no 2 Abrunheira

2710-089 Sintra

Portugal

Sibutramina Blixie

10 mg

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

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

Kapsel, hård

oral anvendelse

Rumænien

| Abbott GmbH & Co.KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co.KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

REDUCTIL 10 mg, capsule

10 mg

Kapsel, hård

oral anvendelse

Rumænien

| Abbott GmbH & Co.KG |
| --- |
| Max-Planck-Ring 2 |
| 65205 Wiesbaden |
| Tyskland |

Abbott GmbH & Co.KG

Max-Planck-Ring 2

65205 Wiesbaden

Tyskland

REDUCTIL 15 mg, capsule

15 mg

Kapsel, hård

oral anvendelse

Rumænien

| SANDOZ S.R.L. ROMÂNIA |
| --- |
| Str. Livezeni nr. 7A, |
| Târgu Mureș, |
| Rumænien |

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureș,

Rumænien

MINIMACIN 10 mg, capsule

10 mg

Kapsel, hård

oral anvendelse

Rumænien

| SANDOZ S.R.L. ROMÂNIA |
| --- |
| Str. Livezeni nr. 7A, |
| Târgu Mureș, |
| Rumænien |

SANDOZ S.R.L. ROMÂNIA

Str. Livezeni nr. 7A,

Târgu Mureș,

Rumænien

MINIMACIN 15 mg, capsule

15 mg

Kapsel, hård

oral anvendelse

Rumænien

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii, nr. 124, |
| Cluj-Napoca, |
| Rumænien |

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Rumænien

SILUTON 10 mg, capsule

10 mg

Kapsel, hård

oral anvendelse

Rumænien

| S.C. TERAPIA S.A. |
| --- |
| Str. Fabricii, nr. 124, |
| Cluj-Napoca, |
| Rumænien |

S.C. TERAPIA S.A.

Str. Fabricii, nr. 124,

Cluj-Napoca,

Rumænien

SILUTON 15 mg, capsule

15 mg

Kapsel, hård

oral anvendelse

Rumænien

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra nr 12, parter, |
| Sector 2, București |
| Rumænien |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra nr 12, parter,

Sector 2, București

Rumænien

SIBUTRAMINĂ TEVA 10 mg, capsule

10 mg

Kapsel, hård

oral anvendelse

Rumænien

| TEVA PHARMACEUTICALS S.R.L. |
| --- |
| Str. Domnița Ruxandra nr 12, parter, |
| Sector 2, București |
| Rumænien |

TEVA PHARMACEUTICALS S.R.L.

Str. Domnița Ruxandra nr 12, parter,

Sector 2, București

Rumænien

SIBUTRAMINĂ TEVA 15 mg, capsule

15 mg

Kapsel, hård

oral anvendelse

Rumænien

| ZENTIVA a.s., |
| --- |
| U kabelovny 130, |
| 102 37 Praga-10 Dolní Měcholupy, Den Tjekkiske republik |

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy, Den Tjekkiske republik

LINDAXA 10 mg, capsule

10 mg

Kapsel, hård

oral anvendelse

Rumænien

| ZENTIVA a.s., |
| --- |
| U kabelovny 130, |
| 102 37 Praga-10 Dolní Měcholupy |
| Den Tjekkiske republik |

ZENTIVA a.s.,

U kabelovny 130,

102 37 Praga-10 Dolní Měcholupy

Den Tjekkiske republik

LINDAXA 15 mg, capsule

15 mg

Kapsel, hård

oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Den Tjekkiske republik |

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Den Tjekkiske republik

LINDAXA 10

10 mg

Kapsel, hård

oral anvendelse

Slovakiet

| Zentiva, k.s. |
| --- |
| Evropská 846/176a |
| 160 00 Praha 6 |
| Den Tjekkiske republik |

Zentiva, k.s.

Evropská 846/176a

160 00 Praha 6

Den Tjekkiske republik

LINDAXA 15

15 mg

Kapsel, hård

oral anvendelse

Slovakiet

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26, 821 02, Bratislava |
| Slovakiet |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26, 821 02, Bratislava

Slovakiet

Sibutramin - Teva 10 mg kapsuly

10 mg

Kapsel, hård

oral anvendelse

Slovakiet

| TEVA Pharmaceuticals Slovakia s.r.o. |
| --- |
| Teslova 26, 821 02, Bratislava |
| Slovakiet |

TEVA Pharmaceuticals Slovakia s.r.o.

Teslova 26, 821 02, Bratislava

Slovakiet

Sibutramin - Teva 15 mg kapsuly

15 mg

Kapsel, hård

oral anvendelse

Slovakiet

| Abbott Laboratories Slovakia s.r.o. |
| --- |
| Karadžicova 10 |
| 821 08 Bratislava |
| Slovakiet |

Abbott Laboratories Slovakia s.r.o.

Karadžicova 10

821 08 Bratislava

Slovakiet

Reductil 10 mg

10 mg

kapsel

oral anvendelse

Slovakiet

| Abbott Laboratories Slovakia s.r.o. |
| --- |
| Karadžicova 10 |
| 821 08 Bratislava |
| Slovakiet |

Abbott Laboratories Slovakia s.r.o.

Karadžicova 10

821 08 Bratislava

Slovakiet

Reductil 15 mg

15 mg

kapsel

oral anvendelse

Slovakiet

| Abbott Laboratories d.o.o. |
| --- |
| Dolenjska c. 242c |
| SI-1000 Ljubljana |
| Slovenien |

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI-1000 Ljubljana

Slovenien

Reductil 10 mg trde kapsule

10 mg

Kapsel, hård

oral anvendelse

Slovakiet

| Abbott Laboratories d.o.o. |
| --- |
| Dolenjska c. 242c |
| SI-1000 Ljubljana |
| Slovenien |

Abbott Laboratories d.o.o.

Dolenjska c. 242c

SI-1000 Ljubljana

Slovenien

Reductil 15 mg trde kapsule

15 mg

Kapsel, hård

oral anvendelse

Slovakiet

| Lek farmacevtska družba d.d., Verovškova c. 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenien |

Lek farmacevtska družba d.d., Verovškova c. 57

SI-1000 Ljubljana

Slovenien

Sibutramin Lek 10 mg trde kapsule

10 mg

Kapsel, hård

oral anvendelse

Slovakiet

| Lek farmacevtska družba d.d., Verovškova c. 57 |
| --- |
| SI-1000 Ljubljana |
| Slovenien |

Lek farmacevtska družba d.d., Verovškova c. 57

SI-1000 Ljubljana

Slovenien

Sibutramin Lek 15 mg trde kapsule

15 mg

Kapsel, hård

oral anvendelse

Spanien

| ABBOTT LABORATORIES, S.A. |
| --- |
| Avda. de Burgos |
| 28050 Madrid |
| Spain |

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spain

REDUCTIL

10 mg

Kapsel, hård

oral anvendelse

Spanien

| ABBOTT LABORATORIES, S.A. |
| --- |
| Avda. de Burgos |
| 28050 Madrid |
| Spanien |

ABBOTT LABORATORIES, S.A.

Avda. de Burgos

28050 Madrid

Spanien

REDUCTIL

15 mg

Kapsel, hård

oral anvendelse

Spanien

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzmán el Bueno 133 |
| Edificio Britania 4oIzq. |
| 28003 MADRID |
| Spanien |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spanien

SIBUTRAMINA TEVA

10 mg

Kapsel, hård

oral anvendelse

Spanien

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzmán el Bueno 133 |
| Edificio Britania 4oIzq. |
| 28003 MADRID |
| Spanien |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzmán el Bueno 133

Edificio Britania 4oIzq.

28003 MADRID

Spanien

SIBUTRAMINA TEVA

15 mg

Kapsel, hård

oral anvendelse

Spanien

| IDIFARMA, DESARROLLO FARMACEUTICO |
| --- |
| Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) |
| Spanien |

IDIFARMA, DESARROLLO FARMACEUTICO

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spanien

SIBUTRAMINA IDIFARMA

10 mg

Kapsel, hård

oral anvendelse

Spanien

| IDIFARMA, DESARROLLO FARMACEUTICO. |
| --- |
| Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra) |
| Spanien |

IDIFARMA, DESARROLLO FARMACEUTICO.

Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)

Spanien

SIBUTRAMINA IDIFARMA

15 mg

Kapsel, hård

oral anvendelse

Sverige

| Abbott Scandinavia AB |
| --- |
| Box 509 169 29 Solna |
| Sverige |

Abbott Scandinavia AB

Box 509 169 29 Solna

Sverige

Reductil

10 mg

Kapsel, hård

oral anvendelse

Sverige

| Abbott Scandinavia AB |
| --- |
| Box 509 169 29 Solna |
| Sverige |

Abbott Scandinavia AB

Box 509 169 29 Solna

Sverige

Reductil

15 mg

Kapsel, hård

oral anvendelse

Sverige

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

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Sibutramin Sandoz

10 mg

Kapsel, hård

oral anvendelse

Sverige

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

Sandoz A/S, C.F.

Tietgens Boulevard 40

DK-5220 Odense SØ

Danmark

Sibutramin Sandoz

15 mg

Kapsel, hård

oral anvendelse

Sverige

| Teva Sweden AB |
| --- |
| Box 1070 |
| 251 10 Helsingborg |
| Sverige |

Teva Sweden AB

Box 1070

251 10 Helsingborg

Sverige

Sibutramine Teva

10 mg

Kapsel, hård

oral anvendelse

Sverige

| Teva Sweden AB |
| --- |
| Box 1070 |
| 251 10 Helsingborg |
| Sverige |

Teva Sweden AB

Box 1070

251 10 Helsingborg

Sverige

Sibutramine Teva

15 mg

Kapsel, hård

oral anvendelse

Storbritannien

| Abbott Laboratories Limited |
| --- |
| Queenborough |
| Kent ME11 5EL |
| Storbritannien |

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

Storbritannien

Reductil 10 mg

10 mg

Kapsel, hård

oral anvendelse

Storbritannien

| Abbott Laboratories Limited |
| --- |
| Queenborough |
| Kent ME11 5EL |
| Storbritannien |

Abbott Laboratories Limited

Queenborough

Kent ME11 5EL

Storbritannien

Reductil 15 mg

15 mg

Kapsel, hård

oral anvendelse

Storbritannien

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne, East Sussex BN22 9AG |
| Storbritannien |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne, East Sussex BN22 9AG

Storbritannien

Sibutramine Hydrochloride 10 mg Capsules

10 mg

Kapsel, hård

oral anvendelse

Storbritannien

| Teva UK Limited |
| --- |
| Brampton Road |
| Hampden Park |
| Eastbourne, East Sussex BN22 9AG |
| Storbritannien |

Teva UK Limited

Brampton Road

Hampden Park

Eastbourne, East Sussex BN22 9AG

Storbritannien

Sibutramine Hydrochloride 15 mg Capsules

15 mg

Kapsel, hård

oral anvendelse

---

BILAG XVI

FORTEGNELSE OVER LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREART, INDGIVELSESVEJ(E) OG INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat | Ansøger eller indehaver af markedsføringstilladelse | Særnavn | Lægemiddelform | Styrke | Dyreart | Doseringshyppighed og indgivelsesvej | Anbefalet dosis | Tilbageholdelsestid |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Det Forenede Kongerige | CEVA Animal Health Limited | Tildren 500 mg lyofilisat til infusionsvæske, opløsning | Lyofilisat til infusionsvæske, opløsning | 500 mg | Heste | Enkeltdosis (behandling kan gentages i samråd med veterinærkirurgen)
  Intravenøs anvendelse | 1 mg/kg legemsvægt (5 ml rekonstitueret opløsning pr. 100 kg) | Nul dage
  Må ikke anvendes til lakterende dyr, der producerer mælk bestemt til menneskeføde |
| Tyskland | CEVA Animal Health Limited | Tildren 500 mg lyofilisat til infusionsvæske, opløsning | Lyofilisat til infusionsvæske, opløsning | 500 mg | Heste | Enkeltdosis (behandling kan gentages i samråd med veterinærkirurgen)
  Intravenøs anvendelse | 1 mg/kg legemsvægt (5 ml rekonstitueret opløsning pr. 100 kg) | Nul dage
  Må ikke anvendes til lakterende dyr, der producerer mælk bestemt til menneskeføde |

Medlemsstat

Ansøger eller indehaver af markedsføringstilladelse

Særnavn

Lægemiddelform

Styrke

Dyreart

Doseringshyppighed og indgivelsesvej

Anbefalet dosis

Tilbageholdelsestid

Det Forenede Kongerige

CEVA Animal Health Limited

Tildren 500 mg lyofilisat til infusionsvæske, opløsning

Lyofilisat til infusionsvæske, opløsning

500 mg

Heste

Enkeltdosis (behandling kan gentages i samråd med veterinærkirurgen)

Intravenøs anvendelse

1 mg/kg legemsvægt (5 ml rekonstitueret opløsning pr. 100 kg)

Nul dage

Må ikke anvendes til lakterende dyr, der producerer mælk bestemt til menneskeføde

Tyskland

CEVA Animal Health Limited

Tildren 500 mg lyofilisat til infusionsvæske, opløsning

Lyofilisat til infusionsvæske, opløsning

500 mg

Heste

Enkeltdosis (behandling kan gentages i samråd med veterinærkirurgen)

Intravenøs anvendelse

1 mg/kg legemsvægt (5 ml rekonstitueret opløsning pr. 100 kg)

Nul dage

Må ikke anvendes til lakterende dyr, der producerer mælk bestemt til menneskeføde

---

BILAG XVII

LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE (EØS)

| Medlemsstat | Indehaver af markedsføringstilladelse | Særnavn Navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Dermapharm GmbH |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Medlemsstat

Indehaver af markedsføringstilladelse

Særnavn Navn

Styrke

Lægemiddelform

Indgivelsesvej

Østrig

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Creme

50 mg/g

Creme

Kutan anvendelse

Østrig

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - dermatologische Emulsion

50 mg/g

Kutan emulsion

Kutan anvendelse

Østrig

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Fettsalbe

50 mg/g

Ointment

Kutan anvendelse

Østrig

| Dermapharm GmbH |
| --- |
| Türkenstraße 25/12 |
| A-1090 Wien |
| Austria |

Dermapharm GmbH

Türkenstraße 25/12

A-1090 Wien

Austria

Parfenac - Salbe

50 mg/g

Salve

Kutan anvendelse

Bulgarien

| 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

Suppositorie

Rektal anvendelse

Bulgarien

| 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

Rektal salve

Rektal anvendelse

Den Tjekkiske republik

| 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

Suppositorie

Rektal anvendelse

Den Tjekkiske republik

| 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

Rektal salve

Rektal anvendelse

Frankrig

| 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

Creme

Kutan anvendelse

Frankrig

| 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

Creme

Kutan anvendelse

Frankrig

| 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

Creme

Kutan anvendelse

Frankrig

| 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

Creme

Kutan anvendelse

Frankrig

| 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

Creme

Kutan anvendelse

Frankrig

| 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

Creme

Kutan anvendelse

Ungarn

| 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

Salve

Kutan anvendelse

Ungarn

| 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

Suppositorie

Rektal anvendelse

Italien

| 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

Creme

Kutan anvendelse

Letland

| 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

Salve

Rektal anvendelse and Kutan anvendelse

Letland

| 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

Suppositorie

Rektal anvendelse

Litauen

| 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

Salve

Kutan anvendelse

Litauen

| 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

Suppositorie

Rektal anvendelse

Luxembourg

| PF MEDICAMENT |
| --- |
| 45, Place Abel Gance |
| 92654 Boulogne Cedex |
| France |

PF MEDICAMENT

45, Place Abel Gance

92654 Boulogne Cedex

France

BUFAL

5 g/100g

Creme

Kutan anvendelse

Portugal

| 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

Salve

Kutan anvendelse

Rumænien

| 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

Suppositorie

Rektal anvendelse

Rumænien

| 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

Rektal Creme

Rektal anvendelse

Slovakiet

| 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

Rektal salve

Rektal anvendelse

Slovakiet

| 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

Suppositorie

Rektal anvendelse

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