# Il-Ġurnal Uffiċjali C 288/2009

| | ISSN 1725-5198
  doi:10.3000/17255198.C_2009.288.mlt |
| --- | --- |
| Il-Ġurnal Uffiċjali
  tal-Unjoni Ewropea | C 288 |
| | |
| Edizzjoni bil-Malti | Informazzjoni u Avviżi | Volum 5227 ta' Novembru 2009 |

ISSN 1725-5198

doi:10.3000/17255198.C_2009.288.mlt

Il-Ġurnal Uffiċjali

tal-Unjoni Ewropea

C 288

Edizzjoni bil-Malti

Informazzjoni u Avviżi

Volum 5227 ta' Novembru 2009

---

| Avviż Nru | Werrej | Paġna |
| --- | --- | --- |
| | IV   Informazzjoni |
| | INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA |
| | Il-Kummissjoni |
| 2009/C 288/01 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta’ Ottubru 2009 sal-31 ta’ Ottubru 2009(Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  ) | 1 |
| 2009/C 288/02 | Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta' Ottubru 2009 sal-31 ta' Ottubru 2009(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill
  jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill
  ) | 11 |

Avviż Nru

Werrej

Paġna

IV   Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

2009/C 288/01

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta’ Ottubru 2009 sal-31 ta’ Ottubru 2009(Ppubblikat skond l-Artikolu 13 jew l-Artikolu 38 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill
  )

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

)

1

2009/C 288/02

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta' Ottubru 2009 sal-31 ta' Ottubru 2009(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill
  jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill
  )

(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill

jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill

)

11

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

MT

---

IV Informazzjoni

INFORMAZZJONI MINN ISTITUZZJONIJIET U KORPI TAL-UNJONI EWROPEA

Il-Kummissjoni

| 27.11.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 288/1 |
| --- | --- | --- | --- |

27.11.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 288/1

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizzazzjonijiet għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta’ Ottubru 2009 sal-31 ta’ Ottubru 2009

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

2009/C 288/01

—   Ħruġ ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004): Aċċettat

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | INN (Isem internazzjonal Mhux Proprjetarju) | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Forma Farmaċewtika | Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku) | Data tan-notifika |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.10.2009 | Onglyza | saxagliptin | 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 | Pillola miksija b’rita | A10BH03 | 5.10.2009 |
| 1.10.2009 | Cimzia | certolizumab pegol | UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | EU/1/09/544/001-002 | Soluzzjoni għall | L04AB05 | 6.10.2009 |
| 1.10.2009 | Simponi | golimumab | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546/001-004 | Soluzzjoni għall-injezzjoni f’siringa mimlija għal-lest | L04AB06 | 6.10.2009 |
| 5.10.2009 | ChondroCelect | Ċelloli awtologi tal-qarċuċa vijabbilment ikkaratterizzati ex vivo li jesprimu l-proteini speċifiċi li jimmarkaw | TiGenix NV, Romeinse straat 12/2, B-3001 LEUVEN, België | EU/1/09/563/001 | Sospensjoni taċ-ċelloli għall-impjantazzjoni | Mhux applikabbli | 7.10.2009 |
| 14.10.2009 | Enyglid | Repaglinide | KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/580/001-018 | Pillola | A10B X02 | 16.10.2009 |
| 15.10.2009 | Resolor | prucalopride | Movetis NV, Veedijk 58, B-2300 Turnhout, België | EU/1/09/581/001-002 | Pilloli miksijin b’rita | A03AE04 | 19.10.2009 |
| 15.10.2009 | Imprida HCT | amlodipine besylate / valsartan / hydrochlorothiazide | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/570/001-060 | Pillola miksija b’rita | C09DX01 | 19.10.2009 |
| 16.10.2009 | Clopidogrel MYLAN Pharma | clopidogrel | Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France | EU/1/09/568/001-018 | Pillola miksija b’rita | B01AC-04 | 20.10.2009 |
| 16.10.2009 | PANDEMIC INFLUENZA VACCINE H5N1 BAXTER | Vaċċin tal-influwenza pandemika (virijon sħiħ H5NI, derivat minn ċellula Vero, inattivat) | Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich | EU/1/09/571/001 | Suspensjoni għall injezzjoni | J07BB01 | 20.10.2009 |
| 16.10.2009 | Exforge HCT | amlodipine besylate / valsartan / hydrochlorothiazide | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569/001-060 | Pillola miksija b’rita | C09DX01 | 20.10.2009 |
| 16.10.2009 | ALENDRONATE SODIUM AND COLECALCIFEROL, MSD | alendronic acid / colecalciferol | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572/001-009 | Pillola | M05BB03 | 20.10.2009 |
| 19.10.2009 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Partijiet purifikati ta’ antiġen ta’ virions maqsumin, mhux attivati A/VietNam/1194/2004 NIBRG-14 (H5N1), | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578/001 | Suspenjoni u emulsjoni għall-emulsjoni għall-injezzjoni | J07BB02 | 21.10.2009 |
| 19.10.2009 | Foclivia | Antiġeni tal-wiċċ tal-virus ta' l-influwenza tar-razza A/Vietnam/1194/2004 (H5N1) | Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina, 1 - Siena, Italia | EU/1/09/577/001-004 | Suspensjoni għall-injezzjoni | J07BB02 | 21.10.2009 |
| 23.10.2009 | Lamivudine Teva | Lamivudine | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/566/001-005 | Pillola miksija b’rita | J05AF05 | 27.10.2009 |
| 23.10.2009 | Biopoin | Epoetin theta | CT Arzneimittel GmbH, Lengeder Straße 42a, D-13407 Berlin, Deutschland | EU/1/09/565/001-028 | Soluzzjoni għall-injezzjoni | B03XA01 | 27.10.2009 |
| 23.10.2009 | ARCALYST | Rilonacept | Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom | EU/1/09/582/001 | Trab u solvent għal soluzzjoni għall-injezzjoni | L04AC04 | 27.10.2009 |
| 23.10.2009 | ILARIS | canakinumab | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564/001-002 | Trab għal soluzzjoni għall-injezzjoni | L04AC08 | 27.10.2009 |
| 29.10.2009 | Eporatio | Epoetin theta | ratiopharm GmbH, Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573/001-028 | Soluzzjoni għall-injezzjoni | B03XA01 | 2.11.2009 |
| 30.10.2009 | Irbesartan Teva | Irbesartan | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/576/001-039 | Pillola miksija b’rita | C09C A04 | 4.11.2009 |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

INN (Isem internazzjonal Mhux Proprjetarju)

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Forma Farmaċewtika

Kodiċi ATC (Kodiċi Anatomiku Terapewtiku Kimiku)

Data tan-notifika

1.10.2009

Onglyza

saxagliptin

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

Pillola miksija b’rita

A10BH03

5.10.2009

1.10.2009

Cimzia

certolizumab pegol

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

EU/1/09/544/001-002

Soluzzjoni għall

L04AB05

6.10.2009

1.10.2009

Simponi

golimumab

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

EU/1/09/546/001-004

Soluzzjoni għall-injezzjoni f’siringa mimlija għal-lest

L04AB06

6.10.2009

5.10.2009

ChondroCelect

Ċelloli awtologi tal-qarċuċa vijabbilment ikkaratterizzati ex vivo li jesprimu l-proteini speċifiċi li jimmarkaw

TiGenix NV, Romeinse straat 12/2, B-3001 LEUVEN, België

EU/1/09/563/001

Sospensjoni taċ-ċelloli għall-impjantazzjoni

Mhux applikabbli

7.10.2009

14.10.2009

Enyglid

Repaglinide

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

EU/1/09/580/001-018

Pillola

A10B X02

16.10.2009

15.10.2009

Resolor

prucalopride

Movetis NV, Veedijk 58, B-2300 Turnhout, België

EU/1/09/581/001-002

Pilloli miksijin b’rita

A03AE04

19.10.2009

15.10.2009

Imprida HCT

amlodipine besylate / valsartan / hydrochlorothiazide

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

EU/1/09/570/001-060

Pillola miksija b’rita

C09DX01

19.10.2009

16.10.2009

Clopidogrel MYLAN Pharma

clopidogrel

Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France

EU/1/09/568/001-018

Pillola miksija b’rita

B01AC-04

20.10.2009

16.10.2009

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

Vaċċin tal-influwenza pandemika (virijon sħiħ H5NI, derivat minn ċellula Vero, inattivat)

Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich

EU/1/09/571/001

Suspensjoni għall injezzjoni

J07BB01

20.10.2009

16.10.2009

Exforge HCT

amlodipine besylate / valsartan / hydrochlorothiazide

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

EU/1/09/569/001-060

Pillola miksija b’rita

C09DX01

20.10.2009

16.10.2009

ALENDRONATE SODIUM AND COLECALCIFEROL, MSD

alendronic acid / colecalciferol

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

EU/1/09/572/001-009

Pillola

M05BB03

20.10.2009

19.10.2009

Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Partijiet purifikati ta’ antiġen ta’ virions maqsumin, mhux attivati A/VietNam/1194/2004 NIBRG-14 (H5N1),

GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578/001

Suspenjoni u emulsjoni għall-emulsjoni għall-injezzjoni

J07BB02

21.10.2009

19.10.2009

Foclivia

Antiġeni tal-wiċċ tal-virus ta' l-influwenza tar-razza A/Vietnam/1194/2004 (H5N1)

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

EU/1/09/577/001-004

Suspensjoni għall-injezzjoni

J07BB02

21.10.2009

23.10.2009

Lamivudine Teva

Lamivudine

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

EU/1/09/566/001-005

Pillola miksija b’rita

J05AF05

27.10.2009

23.10.2009

Biopoin

Epoetin theta

CT Arzneimittel GmbH, Lengeder Straße 42a, D-13407 Berlin, Deutschland

EU/1/09/565/001-028

Soluzzjoni għall-injezzjoni

B03XA01

27.10.2009

23.10.2009

ARCALYST

Rilonacept

Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom

EU/1/09/582/001

Trab u solvent għal soluzzjoni għall-injezzjoni

L04AC04

27.10.2009

23.10.2009

ILARIS

canakinumab

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

EU/1/09/564/001-002

Trab għal soluzzjoni għall-injezzjoni

L04AC08

27.10.2009

29.10.2009

Eporatio

Epoetin theta

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

EU/1/09/573/001-028

Soluzzjoni għall-injezzjoni

B03XA01

2.11.2009

30.10.2009

Irbesartan Teva

Irbesartan

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

EU/1/09/576/001-039

Pillola miksija b’rita

C09C A04

4.11.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004) Aċċettata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Epoetin alfa Hexal | Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411/021-026 | 5.10.2009 |
| 1.10.2009 | Mixtard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/231/001-037 | 5.10.2009 |
| 1.10.2009 | Protaphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234/001-017 | 5.10.2009 |
| 1.10.2009 | Insulatard | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233/001-017 | 5.10.2009 |
| 1.10.2009 | Actrapid | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/230/001-017 | 5.10.2009 |
| 1.10.2009 | Actraphane | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/229/001-037 | 6.10.2009 |
| 1.10.2009 | Binocrit | Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich | EU/1/07/410/021-026 | 5.10.2009 |
| 2.10.2009 | Tasmar | Meda AB, Pipers väg 2A, Solna 170 09, Sverige | EU/1/97/044/001-008 | 6.10.2009 |
| 6.10.2009 | CELVAPAN | Baxter AG, Industriestraße 67, 1221 Wien, Österreich | EU/1/08/506/001 | 8.10.2009 |
| 7.10.2009 | Agenerase | Glaxo Group Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/00/148/001-004 | 9.10.2009 |
| 7.10.2009 | IntronA | Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/99/127/031-039 | 9.10.2009 |
| 8.10.2009 | Mirapexin | Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/97/051/013-027 | 12.10.2009 |
| 8.10.2009 | Sifrol | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050/013-027 | 12.10.2009 |
| 8.10.2009 | Nplate | Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland | EU/1/08/497/001-004 | 12.10.2009 |
| 8.10.2009 | Circadin | RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | EU/1/07/392/001-002 | 12.10.2009 |
| 13.10.2009 | NovoMix | Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142/004-005
  EU/1/00/142/009-022 | 15.10.2009 |
| 13.10.2009 | Olanzapine Neopharma | Neopharma Limited, 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | EU/1/07/426/001-011 | 15.10.2009 |
| 13.10.2009 | CellCept | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005/001-006 | 15.10.2009 |
| 13.10.2009 | Kinzalkomb | Bayer Schering Pharma AG, D-13342 Berlin, Deutschland | EU/1/02/214/001-015 | 15.10.2009 |
| 14.10.2009 | alli | Glaxo Group Limited , Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/07/401/001-006 | 16.10.2009 |
| 14.10.2009 | Onsenal | Pfizer Limited, Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/03/259/001-006 | 16.10.2009 |
| 14.10.2009 | PritorPlus | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/02/215/001-021 | 16.10.2009 |
| 14.10.2009 | Ammonaps | Swedish Orphan International AB, Drottninggatan 98, 111 60 Stockholm, Sverige | EU/1/99/120/001-004 | 19.10.2009 |
| 15.10.2009 | Nexavar | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/06/342/001 | 19.10.2009 |
| 16.10.2009 | Helixate NexGen | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/00/144/001-004 | 20.10.2009 |
| 16.10.2009 | Aptivus | Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/05/315/001-002 | 20.10.2009 |
| 16.10.2009 | KOGENATE Bayer | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/00/143/001-011 | 20.10.2009 |
| 19.10.2009 | Thalidomide Celgene | Celgene Europe Limited, Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom | EU/1/08/443/001 | 21.10.2009 |
| 19.10.2009 | Ribavirin Teva Pharma BV | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/527/001-016 | 21.10.2009 |
| 19.10.2009 | Revlimid | Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom | EU/1/07/391/001-004 | 21.10.2009 |
| 19.10.2009 | Prepandrix | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, Rixensart, B-1330 Belgique | EU/1/08/453/002 | 21.10.2009 |
| 19.10.2009 | Wilzin | Orphan Europe S.a.r.l., Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France | EU/1/04/286/001-002 | 21.10.2009 |
| 19.10.2009 | Olanzapine Teva | Teva Pharma B.V., Computerweg 10, DR Utrecht 3542, Nederland | EU/1/07/427/001-057 | 21.10.2009 |
| 20.10.2009 | Vidaza | Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom | EU/1/08/488/001 | 22.10.2009 |
| 21.10.2009 | Xarelto | Bayer Schering Pharma AG, 13342 Berlin, Deutschland | EU/1/08/472/001-008 | 23.10.2009 |
| 21.10.2009 | Metalyse | Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/00/169/004-006 | 23.10.2009 |
| 21.10.2009 | Filgrastim Hexal | HEXAL AG, Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/08/496/001-008 | 26.10.2009 |
| 21.10.2009 | Zarzio | Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/08/495/001-008 | 23.10.2009 |
| 23.10.2009 | Rebif | Merck Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/98/063/001-010 | 27.10.2009 |
| 23.10.2009 | Prezista | Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse – België | EU/1/06/380/001-005 | 27.10.2009 |
| 23.10.2009 | Olanzapine Mylan | Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/08/475/001-034 | 27.10.2009 |
| 23.10.2009 | Norvir | Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom | EU/1/96/016/001
  EU/1/96/016/003-004 | 27.10.2009 |
| 23.10.2009 | PEGASYS | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221/001-010 | 27.10.2009 |
| 23.10.2009 | Invanz | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/02/216/001-002 | 27.10.2009 |
| 23.10.2009 | Procoralan | Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/316/001-014 | 27.10.2009 |
| 23.10.2009 | Teslascan | GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norway | EU/1/97/040/001-002 | 27.10.2009 |
| 23.10.2009 | Vistide | Gilead Sciences International Limited, Cambridge, CB21 6GT, United Kingdom | EU/1/97/037/001 | 27.10.2009 |
| 23.10.2009 | RotaTeq | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, Lyon 69007, France | EU/1/06/348/001-002 | 27.10.2009 |
| 23.10.2009 | Tamiflu | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222/001-004 | 27.10.2009 |
| 23.10.2009 | Corlentor | Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France | EU/1/05/317/001-014 | 27.10.2009 |
| 23.10.2009 | Neulasta | Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227/001-004 | 27.10.2009 |
| 23.10.2009 | Ellaone | Laboratoire HRA Pharma, 15, rue Béranger, 75003 Paris, France | EU/1/09/522/001 | 27.10.2009 |
| 28.10.2009 | Xelevia | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382/001-018 | 30.10.2009 |
| 28.10.2009 | TESAVEL | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435/001-018 | 30.10.2009 |
| 28.10.2009 | Pradaxa | Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442/001-008 | 2.11.2009 |
| 28.10.2009 | Aranesp | Amgen Europe B.V., Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185/001-022
  EU/1/01/185/031-099 | 30.10.2009 |
| 28.10.2009 | Zerit | Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009/001-009 | 30.10.2009 |
| 28.10.2009 | Arava | Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Deutschland | EU/1/99/118/001-010 | 30.10.2009 |
| 28.10.2009 | Yondelis | Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), España | EU/1/07/417/001-002 | 30.10.2009 |
| 28.10.2009 | Myozyme | Genzyme Europe B.V., Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/333/001-003 | 2.11.2009 |
| 28.10.2009 | SUTENT | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/1/06/347/001-008 | 30.10.2009 |
| 28.10.2009 | Integrilin | Glaxo Group Ltd, Greenford, Middlesex, UB6 ONN, United Kingdom | EU/1/99/109/001-002 | 30.10.2009 |
| 28.10.2009 | BeneFIX | Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom | EU/1/97/047/001-007 | 30.10.2009 |
| 28.10.2009 | RoActemra | Roche Registration Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492/001-006 | 30.10.2009 |
| 28.10.2009 | Beromun | Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | EU/1/99/097/001 | 2.11.2009 |
| 28.10.2009 | Epivir | Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom | EU/1/96/015/001-005 | 30.10.2009 |
| 28.10.2009 | IXIARO | Intercell AG, Campus Vienna Biocenter 3 A-1030 Wien, Österreich | EU/1/08/501/001-002 | 30.10.2009 |
| 28.10.2009 | Efficib | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457/001-016 | 30.10.2009 |
| 28.10.2009 | Janumet | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455/001-016 | 30.10.2009 |
| 28.10.2009 | Noxafil | SP Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België | EU/1/05/320/001 | 30.10.2009 |
| 28.10.2009 | Velcade | Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, België | EU/1/04/274/001-002 | 30.10.2009 |
| 28.10.2009 | Zostavax | Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, 69007 Lyon, France | EU/1/06/341/001-013 | 30.10.2009 |
| 28.10.2009 | Velmetia | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456/001-016 | 30.10.2009 |
| 29.10.2009 | Sebivo | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/388/001-003 | 2.11.2009 |
| 29.10.2009 | ADROVANCE | Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364/001-009 | 2.11.2009 |
| 29.10.2009 | Remicade | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/99/116/001-005 | 2.11.2009 |
| 29.10.2009 | INOmax | INO Therapeutics AB, SE-181 81 Lidingö, Sverige | EU/1/01/194/001-002 | 3.11.2009 |
| 30.10.2009 | Xagrid | Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295/001 | 4.11.2009 |
| 30.10.2009 | Zalasta | KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/07/415/001-056 | 4.11.2009 |
| 30.10.2009 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Deutschland | EU/1/06/368/001-168 | 4.11.2009 |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

1.10.2009

Epoetin alfa Hexal

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

EU/1/07/411/021-026

5.10.2009

1.10.2009

Mixtard

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

EU/1/02/231/001-037

5.10.2009

1.10.2009

Protaphane

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

EU/1/02/234/001-017

5.10.2009

1.10.2009

Insulatard

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

EU/1/02/233/001-017

5.10.2009

1.10.2009

Actrapid

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

EU/1/02/230/001-017

5.10.2009

1.10.2009

Actraphane

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

EU/1/02/229/001-037

6.10.2009

1.10.2009

Binocrit

Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich

EU/1/07/410/021-026

5.10.2009

2.10.2009

Tasmar

Meda AB, Pipers väg 2A, Solna 170 09, Sverige

EU/1/97/044/001-008

6.10.2009

6.10.2009

CELVAPAN

Baxter AG, Industriestraße 67, 1221 Wien, Österreich

EU/1/08/506/001

8.10.2009

7.10.2009

Agenerase

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

EU/1/00/148/001-004

9.10.2009

7.10.2009

IntronA

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

EU/1/99/127/031-039

9.10.2009

8.10.2009

Mirapexin

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

EU/1/97/051/013-027

12.10.2009

8.10.2009

Sifrol

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

EU/1/97/050/013-027

12.10.2009

8.10.2009

Nplate

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

EU/1/08/497/001-004

12.10.2009

8.10.2009

Circadin

RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392/001-002

12.10.2009

13.10.2009

NovoMix

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

EU/1/00/142/004-005

EU/1/00/142/009-022

15.10.2009

13.10.2009

Olanzapine Neopharma

Neopharma Limited, 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom

EU/1/07/426/001-011

15.10.2009

13.10.2009

CellCept

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

EU/1/96/005/001-006

15.10.2009

13.10.2009

Kinzalkomb

Bayer Schering Pharma AG, D-13342 Berlin, Deutschland

EU/1/02/214/001-015

15.10.2009

14.10.2009

alli

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

EU/1/07/401/001-006

16.10.2009

14.10.2009

Onsenal

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

EU/1/03/259/001-006

16.10.2009

14.10.2009

PritorPlus

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/02/215/001-021

16.10.2009

14.10.2009

Ammonaps

Swedish Orphan International AB, Drottninggatan 98, 111 60 Stockholm, Sverige

EU/1/99/120/001-004

19.10.2009

15.10.2009

Nexavar

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/06/342/001

19.10.2009

16.10.2009

Helixate NexGen

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/00/144/001-004

20.10.2009

16.10.2009

Aptivus

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

EU/1/05/315/001-002

20.10.2009

16.10.2009

KOGENATE Bayer

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/00/143/001-011

20.10.2009

19.10.2009

Thalidomide Celgene

Celgene Europe Limited, Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom

EU/1/08/443/001

21.10.2009

19.10.2009

Ribavirin Teva Pharma BV

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

EU/1/09/527/001-016

21.10.2009

19.10.2009

Revlimid

Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom

EU/1/07/391/001-004

21.10.2009

19.10.2009

Prepandrix

GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/08/453/002

21.10.2009

19.10.2009

Wilzin

Orphan Europe S.a.r.l., Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France

EU/1/04/286/001-002

21.10.2009

19.10.2009

Olanzapine Teva

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

EU/1/07/427/001-057

21.10.2009

20.10.2009

Vidaza

Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom

EU/1/08/488/001

22.10.2009

21.10.2009

Xarelto

Bayer Schering Pharma AG, 13342 Berlin, Deutschland

EU/1/08/472/001-008

23.10.2009

21.10.2009

Metalyse

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

EU/1/00/169/004-006

23.10.2009

21.10.2009

Filgrastim Hexal

HEXAL AG, Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/08/496/001-008

26.10.2009

21.10.2009

Zarzio

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/08/495/001-008

23.10.2009

23.10.2009

Rebif

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

EU/1/98/063/001-010

27.10.2009

23.10.2009

Prezista

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

EU/1/06/380/001-005

27.10.2009

23.10.2009

Olanzapine Mylan

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

EU/1/08/475/001-034

27.10.2009

23.10.2009

Norvir

Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom

EU/1/96/016/001

EU/1/96/016/003-004

27.10.2009

23.10.2009

PEGASYS

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

EU/1/02/221/001-010

27.10.2009

23.10.2009

Invanz

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

EU/1/02/216/001-002

27.10.2009

23.10.2009

Procoralan

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

EU/1/05/316/001-014

27.10.2009

23.10.2009

Teslascan

GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norway

EU/1/97/040/001-002

27.10.2009

23.10.2009

Vistide

Gilead Sciences International Limited, Cambridge, CB21 6GT, United Kingdom

EU/1/97/037/001

27.10.2009

23.10.2009

RotaTeq

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

EU/1/06/348/001-002

27.10.2009

23.10.2009

Tamiflu

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

EU/1/02/222/001-004

27.10.2009

23.10.2009

Corlentor

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

EU/1/05/317/001-014

27.10.2009

23.10.2009

Neulasta

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

EU/1/02/227/001-004

27.10.2009

23.10.2009

Ellaone

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

EU/1/09/522/001

27.10.2009

28.10.2009

Xelevia

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

EU/1/07/382/001-018

30.10.2009

28.10.2009

TESAVEL

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

EU/1/07/435/001-018

30.10.2009

28.10.2009

Pradaxa

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

EU/1/08/442/001-008

2.11.2009

28.10.2009

Aranesp

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

EU/1/01/185/001-022

EU/1/01/185/031-099

30.10.2009

28.10.2009

Zerit

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

EU/1/96/009/001-009

30.10.2009

28.10.2009

Arava

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

EU/1/99/118/001-010

30.10.2009

28.10.2009

Yondelis

Pharma Mar, S.A., Avda. de los Reyes 1, Polígono Industrial La Mina, 28770 Colmenar Viejo (Madrid), España

EU/1/07/417/001-002

30.10.2009

28.10.2009

Myozyme

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

EU/1/06/333/001-003

2.11.2009

28.10.2009

SUTENT

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

EU/1/06/347/001-008

30.10.2009

28.10.2009

Integrilin

Glaxo Group Ltd, Greenford, Middlesex, UB6 ONN, United Kingdom

EU/1/99/109/001-002

30.10.2009

28.10.2009

BeneFIX

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

EU/1/97/047/001-007

30.10.2009

28.10.2009

RoActemra

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

EU/1/08/492/001-006

30.10.2009

28.10.2009

Beromun

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

EU/1/99/097/001

2.11.2009

28.10.2009

Epivir

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

EU/1/96/015/001-005

30.10.2009

28.10.2009

IXIARO

Intercell AG, Campus Vienna Biocenter 3 A-1030 Wien, Österreich

EU/1/08/501/001-002

30.10.2009

28.10.2009

Efficib

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

EU/1/08/457/001-016

30.10.2009

28.10.2009

Janumet

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

EU/1/08/455/001-016

30.10.2009

28.10.2009

Noxafil

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

EU/1/05/320/001

30.10.2009

28.10.2009

Velcade

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

EU/1/04/274/001-002

30.10.2009

28.10.2009

Zostavax

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

EU/1/06/341/001-013

30.10.2009

28.10.2009

Velmetia

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

EU/1/08/456/001-016

30.10.2009

29.10.2009

Sebivo

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

EU/1/07/388/001-003

2.11.2009

29.10.2009

ADROVANCE

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

EU/1/06/364/001-009

2.11.2009

29.10.2009

Remicade

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

EU/1/99/116/001-005

2.11.2009

29.10.2009

INOmax

INO Therapeutics AB, SE-181 81 Lidingö, Sverige

EU/1/01/194/001-002

3.11.2009

30.10.2009

Xagrid

Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/001

4.11.2009

30.10.2009

Zalasta

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

EU/1/07/415/001-056

4.11.2009

30.10.2009

Insulin Human Winthrop

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

EU/1/06/368/001-168

4.11.2009

—   Irtirar ta’ sospensjoni ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 20 tar-Regolament (KE) Nru 726/2004)

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 8.10.2009 | Optison | GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norway | EU/1/98/065/001-002 | 12.10.2009 |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

8.10.2009

Optison

GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norway

EU/1/98/065/001-002

12.10.2009

—   Modifika ta’ awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 38 tar-Regolament (KE) Nru 726/2004): Aċċettata

| Data tad-Deċiżjoni | Isem tal-prodott mediċinali | Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq | Numru tal-partita fir-Reġistru tal-Komunità | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Oxyglobin | Biopure Netherlands B.V., Parnassustoren, Locatellikade 1, NL - 1076 AZ Amsterdam, Nederland | EU/2/99/015/001-002 | 5.10.2009 |
| 1.10.2009 | Stronghold | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/99/014/001-012 | 5.10.2009 |
| 6.10.2009 | Nobilis Influenza H5N2 | Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | EU/2/06/061/001-004 | 8.10.2009 |
| 8.10.2009 | Naxcel | Pfizer Ltd, Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | EU/2/05/053/003 | 12.10.2009 |
| 8.10.2009 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited, Loughrea, Co. Galway, IRELAND | EU/2/07/078/005-008 | 12.10.2009 |
| 8.10.2009 | Meloxidyl | CEVA SANTE ANIMALE, Z.I. la Ballastière, 33500 Libourne, France | EU/2/06/070/004 | 12.10.2009 |
| 21.10.2009 | Suprelorin | VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | EU/2/07/072/001-002 | 23.10.2009 |
| 30.10.2009 | Easotic | VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France | EU/2/08/085/001 | 4.11.2009 |

Data tad-Deċiżjoni

Isem tal-prodott mediċinali

Detentur ta’ l-awtorizzazzjoni għat-tqegħid fis-suq

Numru tal-partita fir-Reġistru tal-Komunità

Data tan-notifika

1.10.2009

Oxyglobin

Biopure Netherlands B.V., Parnassustoren, Locatellikade 1, NL - 1076 AZ Amsterdam, Nederland

EU/2/99/015/001-002

5.10.2009

1.10.2009

Stronghold

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

EU/2/99/014/001-012

5.10.2009

6.10.2009

Nobilis Influenza H5N2

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

EU/2/06/061/001-004

8.10.2009

8.10.2009

Naxcel

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

EU/2/05/053/003

12.10.2009

8.10.2009

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited, Loughrea, Co. Galway, IRELAND

EU/2/07/078/005-008

12.10.2009

8.10.2009

Meloxidyl

CEVA SANTE ANIMALE, Z.I. la Ballastière, 33500 Libourne, France

EU/2/06/070/004

12.10.2009

21.10.2009

Suprelorin

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

EU/2/07/072/001-002

23.10.2009

30.10.2009

Easotic

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

EU/2/08/085/001

4.11.2009

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

| L-Aġenzija Ewropea tal-Mediċini |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| UNITED KINGDOM |

L-Aġenzija Ewropea tal-Mediċini

7, Westferry Circus, Canary Wharf

London E14 4HB

UNITED KINGDOM

---

(1)  ĠU L 136, tat-30 ta’ April 2004, paġna 1.

---

| 27.11.2009 | MT | Il-Ġurnal Uffiċjali tal-Unjoni Ewropea | C 288/11 |
| --- | --- | --- | --- |

27.11.2009

MT

Il-Ġurnal Uffiċjali tal-Unjoni Ewropea

C 288/11

---

Taqsira tad-deċiżjonijiet tal-Komunità dwar l-awtorizazzjoni għat-tqegħid fis-suq fir-rigward ta’ prodotti mediċinali mill-1 ta' Ottubru 2009 sal-31 ta' Ottubru 2009

(Deċiżjonijiet meħuda skond l-Artikolu 34 tad-Direttiva 2001/83/KE tal-Parlament Ewropew u tal-Kunsill
   (1)
  jew Artikolu 38 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u tal-Kunsill
   (2)
  )

2009/C 288/02

-   Ħruġ, manteniment jew modifikazzjoni ta’ l-awtorizazzjonijiet nazzjonali tat-tqegħid fis-suq

| Data tad-Deċiżjoni | Isem(ijiet) tal-prodott mediċinali | Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq | Stat Membru konċernat | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Simponi | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | Din id-Deċiżjoni hija indirizzata lill-Istati Membri | 5.10.2009 |
| 1.10.2009 | Ivermectin | Ara l-Anness I | Ara l-Anness I | 5.10.2009 |
| 1.10.2009 | Topamax | Ara l-Anness II | Ara l-Anness II | 5.10.2009 |
| 1.10.2009 | Cimzia | UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | Din id-Deċiżjoni hija indirizzata lill-Istati Membri | 5.10.2009 |
| 2.10.2009 | Avalox | Ara l-Anness III | Ara l-Anness III | 6.10.2009 |
| 2.10.2009 | Octegra | Ara l-Anness IV | Ara l-Anness IV | 6.10.2009 |
| 5.10.2009 | ChondroCelect | TiGenix NV, Romeinse straat 12/2, B-3001 LEUVEN, België | Din id-Deċiżjoni hija indirizzata lill-Istati Membri | 6.10.2009 |
| 6.10.2009 | Fentrix | Ara l-Anness V | Ara l-Anness V | 7.10.2009 |
| 15.10.2009 | Meronem | Ara l-Anness VI | Ara l-Anness VI | 19.10.2009 |
| 15.10.2009 | Pulmotil AC | Ara l-Anness VII | Ara l-Anness VII | 19.10.2009 |
| 15.10.2009 | Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix | Ara l-Anness VIII | Ara l-Anness VIII | 19.10.2009 |
| 16.10.2009 | Nimesulide | Ara l-Anness IX | Ara l-Anness IX | 19.10.2009 |
| 19.10.2009 | Augmentin | Ara l-Anness X | Ara l-Anness X | 21.10.2009 |
| 23.10.2009 | ILARIS | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Din id-Deċiżjoni hija indirizzata lill-Istati Membri | 26.10.2009 |
| 23.10.2009 | ARCALYST | Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom | Din id-Deċiżjoni hija indirizzata lill-Istati Membri | 26.10.2009 |

Data tad-Deċiżjoni

Isem(ijiet) tal-prodott mediċinali

Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq

Stat Membru konċernat

Data tan-notifika

1.10.2009

Simponi

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

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

5.10.2009

1.10.2009

Ivermectin

Ara l-Anness I

Ara l-Anness I

5.10.2009

1.10.2009

Topamax

Ara l-Anness II

Ara l-Anness II

5.10.2009

1.10.2009

Cimzia

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

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

5.10.2009

2.10.2009

Avalox

Ara l-Anness III

Ara l-Anness III

6.10.2009

2.10.2009

Octegra

Ara l-Anness IV

Ara l-Anness IV

6.10.2009

5.10.2009

ChondroCelect

TiGenix NV, Romeinse straat 12/2, B-3001 LEUVEN, België

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

6.10.2009

6.10.2009

Fentrix

Ara l-Anness V

Ara l-Anness V

7.10.2009

15.10.2009

Meronem

Ara l-Anness VI

Ara l-Anness VI

19.10.2009

15.10.2009

Pulmotil AC

Ara l-Anness VII

Ara l-Anness VII

19.10.2009

15.10.2009

Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix

Ara l-Anness VIII

Ara l-Anness VIII

19.10.2009

16.10.2009

Nimesulide

Ara l-Anness IX

Ara l-Anness IX

19.10.2009

19.10.2009

Augmentin

Ara l-Anness X

Ara l-Anness X

21.10.2009

23.10.2009

ILARIS

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

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

26.10.2009

23.10.2009

ARCALYST

Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom

Din id-Deċiżjoni hija indirizzata lill-Istati Membri

26.10.2009

-   Revoka ta’ l-awtorizzazzjoni nazzjonali għat-tqegħid fis-suq

| Data tad-Deċiżjoni | Isem(ijiet) tal-prodott mediċinali | Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq | Stat Membru konċernat | Data tan-notifika |
| --- | --- | --- | --- | --- |
| 30.10.2009 | Fentrans | Ara l-Anness XI | Ara l-Anness XI | 4.11.2009 |
| 30.10.2009 | Matripain | Ara l-Anness XII | Ara l-Anness XII | 4.11.2009 |
| 30.10.2009 | Matrigesic | Ara l-Anness XIII | Ara l-Anness XIII | 4.11.2009 |
| 30.10.2009 | Fentador | Ara l-Anness XIV | Ara l-Anness XIV | 4.11.2009 |
| 30.10.2009 | Fentastad | Ara l-Anness XV | Ara l-Anness XV | 4.11.2009 |

Data tad-Deċiżjoni

Isem(ijiet) tal-prodott mediċinali

Detentur(i) ta’ l-awtorizazzjoni għat-tqegħid fis-suq

Stat Membru konċernat

Data tan-notifika

30.10.2009

Fentrans

Ara l-Anness XI

Ara l-Anness XI

4.11.2009

30.10.2009

Matripain

Ara l-Anness XII

Ara l-Anness XII

4.11.2009

30.10.2009

Matrigesic

Ara l-Anness XIII

Ara l-Anness XIII

4.11.2009

30.10.2009

Fentador

Ara l-Anness XIV

Ara l-Anness XIV

4.11.2009

30.10.2009

Fentastad

Ara l-Anness XV

Ara l-Anness XV

4.11.2009

---

(1)  ĠU L 311, 28.11.01, p. 67

(2)  ĠU L 311, 28.11.01, p. 1

---

ANNESS I

LISTA TAL-ISMIJIET, QAWWIET TAL-PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI TA’ ANNIMALI, MNEJN JINGĦATA, DOŻA RAKKOMANDATA U DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u Indirizz | Isem ivvintat | Qawwiet | Speċi ta’ annimal | Mnejn jingħata | Doża rakkomandata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Chanelle Animal Health Ltd |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Stat Membru

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u Indirizz

Isem ivvintat

Qawwiet

Speċi ta’ annimal

Mnejn jingħata

Doża rakkomandata

L-Awstrija

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec injection Injektionslöng für Rinder und Schweine

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Awstrija

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Awstrija

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

L-Awstrija

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Awstrija

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 10 mg/ml Injektionssuspension für Rinder, Schafe und Schweine

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Awstrija

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin – Injektionslösung für Tiere

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Awstrija

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

L-Awstrija

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC Injektionslösung Für Tiere: Rinder, Schafe, Schweine

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Awstrija

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin

Injektionlösung für Rinder

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Il-Belġju

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

BOVIMEC B

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Belġju

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN 10MG/ML

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Belġju

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN CATTLE

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Belġju

| MERIAL Belgium S.A. |
| --- |
| Bld Sylvain Dupuis 243 |
| 1070 Bruxelles |
| Belgium |

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

IVOMEC F

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Il-Belġju

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Belġju

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC 1 % Solution injectable

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Belġju

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC F solution injectable

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Il-Belġju

| MERIAL Belgium S.A. |
| --- |
| Bld Sylvain Dupuis 243 |
| 1070 Bruxelles |
| Belgium |

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

Ivomec

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Belġju

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

QUALIMEC 10MG/ML

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Belġju

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Oplossing voor

Injectie voor rundvee

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Il-Bulgarija

| Intervet International B.V. |
| --- |
| Wim de Korvrstraat 35, |
| 5831 AA, Boxmeer, |
| The Netherlands |

Intervet International B.V.

Wim de Korvrstraat 35,

5831 AA, Boxmeer,

The Netherlands

Ivotan LA

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Bulgarija

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 % injectable solution

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Bulgarija

| Alfasan International B.V., |
| --- |
| P.O. Box 78, |
| 3440 AB Woerden, |
| The Netherlands |

Alfasan International B.V.,

P.O. Box 78,

3440 AB Woerden,

The Netherlands

Alfamec 1 %

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Bulgarija

| BIOVET JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Pesthera |
| Bulgaria |

BIOVET JSC

39 Petar Rakov Str.

4550 Pesthera

Bulgaria

Pandex 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Bulgarija

| Centrovet Ltd. |
| --- |
| Av.Los Cerrilos 602 |
| Santiago, |
| Chile |

Centrovet Ltd.

Av.Los Cerrilos 602

Santiago,

Chile

Microdes Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Il-Bulgarija

| Interchemie werken „de Adelaar” BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| The Netherlands |

Interchemie werken „de Adelaar” BV

Horsterweg 26A

5811 AC Castenray

The Netherlands

Intermectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Bulgarija

| Invesa International S.A. |
| --- |
| Esmeralda 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

Invesa International S.A.

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

Promectine

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Bulgarija

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ċipru

| Panchris Feeds Ltd. |
| --- |
| P.O.Box 40261, |
| 6302 Larnaca |
| Cyprus |

Panchris Feeds Ltd.

P.O.Box 40261,

6302 Larnaca

Cyprus

Bimectin Injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ċipru

| Vetagrica Ltd |
| --- |
| 3 Othellou Street, |
| 2540 Dhali Industrial Estate |
| Nicosia |
| Cyprus |

Vetagrica Ltd

3 Othellou Street,

2540 Dhali Industrial Estate

Nicosia

Cyprus

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Ċipru

| Spyros Stavrinides Chemicals Ltd |
| --- |
| 28 Stasinou Avenue, |
| 1060 Nicosia, |
| Cyprus |

Spyros Stavrinides Chemicals Ltd

28 Stasinou Avenue,

1060 Nicosia,

Cyprus

Noromectin injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| Vétoquinol s.r.o., |
| --- |
| Zámečnícka 411, |
| 288 02 Nymburk, |
| Czech Republic |

Vétoquinol s.r.o.,

Zámečnícka 411,

288 02 Nymburk,

Czech Republic

Biomectin 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| Bremer Pharma GmbH |
| --- |
| Cherbourger Str. 25 |
| 27540 Bremerhaven |
| Germany |

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| CEVA Animal Health Slovakia, spol. s r.o. |
| --- |
| Račianska 77 |
| 83 102 BRATISLAVA |
| Slovak Republic |

CEVA Animal Health Slovakia, spol. s r.o.

Račianska 77

83 102 BRATISLAVA

Slovak Republic

Cevamec 1 % inj. ad us. vet.

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 % inj. ad. us. vet.

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Super inj. a.u.v.

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Inj ad us vet

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec inj. ad us. vet.

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| Bioveta a.s., |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta a.s.,

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

Biomec 10 mg/ml

Injekční roztok

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Ċeka

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin injekční roztok pro skot

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Id-Danimarka

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Vet

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Id-Danimarka

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec Vet

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Id-Danimarka

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimec Vet

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Id-Danimarka

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomec vet.

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Id-Danimarka

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Ivermectin »Virbac« Vet., injektionsvæske, opløsning

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Id-Danimarka

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Coopermec Vet

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Id-Danimarka

| Merial Norden A/S |
| --- |
| Mileparken 20 E |
| 2740 Skovlunde |
| Denmark |

Merial Norden A/S

Mileparken 20 E

2740 Skovlunde

Denmark

Ivomec vet., injektionsvæske 10 mg/ml

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 %

injection, süstelahus

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 % injectable solution

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| Bremer Pharma GmbH |
| --- |
| Cherbourger Str. 25 |
| 27540 Bremerhaven |
| Germany |

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Estonja

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Finlandja

| Scanvet Eläinlääkkeet Oy |
| --- |
| PL 27 |
| 13721 PAROLA |
| Finland |

Scanvet Eläinlääkkeet Oy

PL 27

13721 PAROLA

Finland

Animec vet

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Finlandja

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin vet

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Finlandja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec

10 mg/ml vet injektioneste, liuos

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Finlandja

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec injection10 mg/ml solution for injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Finlandja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Vet 10mg/ml

Solution for Injection

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Finlandja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC VET 10 mg/ml injektioneste, liuos

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Franza

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC D

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Franza

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC SOLUTION INJECTABLE POUR BOVINS

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Franza

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC D SOLUTION INJECTABLE

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Franza

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC Solution Injectable pour Bovins Porçins Ovins

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

IVERMECTINE ECO 10 MG/ML SOLUTION I NJECTABLE

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

QUALIMEC 10 MG/ML SOLUTION

INJECTABLE

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN BOVIN

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Franza

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

CEVAMEC BOVINS OVINS SOLUTION INJECTABLE

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Franza

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Magamectine iInjectable, solution injectable

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Medimec Injectable, Solution Injectable

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % Solution Injectable Bovine, Porcins

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Franza

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectine Solution Injectable pour bovins

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Franza

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| MERIAL GmbH |
| --- |
| Am Söldnermoos 6 |
| D-85399 Hallbergmoos |
| Germany |

MERIAL GmbH

Am Söldnermoos 6

D-85399 Hallbergmoos

Germany

Ivomec

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanectin Injektion

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Diapec R

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Wedemec R

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Sumex Injektion für Rinder

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % Injektion

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Ġermanja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec

Inektionslösung

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Greċja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 %

1 % Evέσiμo Δiάλuμa

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin 1 %

1 % Evέσiμo Δiάλuμa

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| Chanelle Pharmaceuticals Manufacturing Ltd., |
| --- |
| Loughrea, Co. Galway, |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Inj. Sol.

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| VETERIN ABEE |
| --- |
| Aspropyrgos Attikis |
| 19300 |
| Greece |

VETERIN ABEE

Aspropyrgos Attikis

19300

Greece

VETERMEC

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| PNG Gerolymatos S.A. |
| --- |
| 13, Asklipiou |
| 145 68 KRYONERI, ATTICA |
| Greece |

PNG Gerolymatos S.A.

13, Asklipiou

145 68 KRYONERI, ATTICA

Greece

VALANEQ

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

MAXIMEC

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Greċja

| SCHERING PLOUGH SA |
| --- |
| 65,Ag Dimitriou |
| 17455, Athens |
| Greece |

SCHERING PLOUGH SA

65,Ag Dimitriou

17455, Athens

Greece

TIZOVAL

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Ungerija

| Chanelle Pharmaceuticals Manufacturing Ltd., |
| --- |
| Loughrea, Co. Galway, |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Bayer Hungária Ltd. |
| --- |
| H-1123 Budapest |
| Alkotás u. 50. |
| Hungary |

Bayer Hungária Ltd.

H-1123 Budapest

Alkotás u. 50.

Hungary

Baymec Trio 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Ceva-Phylaxia Oltóanyagtermelő Zrt. |
| --- |
| Szállás u. 5 |
| 1107 Budapest |
| Hungary |

Ceva-Phylaxia Oltóanyagtermelő Zrt.

Szállás u. 5

1107 Budapest

Hungary

Cevamec 1 % injekció A.U.V

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Divasa Farmavic Hungaria Ltd. |
| --- |
| H-6070 Izsák, Kossuth L. u. 60. |
| Hungary |

Divasa Farmavic Hungaria Ltd.

H-6070 Izsák, Kossuth L. u. 60.

Hungary

ECOMECTIN

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Bremer Pharma GmbH. |
| --- |
| Werkstrasse 42 |
| 34414 Warburg-Scherfede |
| Germany |

Bremer Pharma GmbH.

Werkstrasse 42

34414 Warburg-Scherfede

Germany

FROMMECTIN

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Invesa International S.A. |
| --- |
| Esmeralda 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

Invesa International S.A.

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

IVERGEN PREMIUM LA

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Veterina Polska Sp. Zo.o. |
| --- |
| Ul. Mogilska 80, |
| 31546 Krakow |
| Poland |

Veterina Polska Sp. Zo.o.

Ul. Mogilska 80,

31546 Krakow

Poland

Iverktin Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| VMD Animal Health Ltd. |
| --- |
| Közraktár u. 22/b. II. 3., |
| 1093 Budapest |
| Hungary |

VMD Animal Health Ltd.

Közraktár u. 22/b. II. 3.,

1093 Budapest

Hungary

IVERVETO 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec injekció A.U.V.

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec super injekció A.U.V.

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Ungerija

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Ungerija

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Vetimec 10 mg/ml solution for injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| C-Corp, |
| --- |
| 78 Coombe Road, |
| New Malden, |
| Surrey KT3 4QS, |
| United Kingdom |

C-Corp,

78 Coombe Road,

New Malden,

Surrey KT3 4QS,

United Kingdom

Kilo-mec 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| C-Corp, |
| --- |
| 78 Coombe Road, |
| New Malden, |
| Surrey KT3 4QS, |
| United Kingdom |

C-Corp,

78 Coombe Road,

New Malden,

Surrey KT3 4QS,

United Kingdom

Mastermectin 1 Per Cent

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| C-Corp, |
| --- |
| 78 Coombe Road, |
| New Malden, |
| Surrey KT3 4QS, |
| United Kingdom |

C-Corp,

78 Coombe Road,

New Malden,

Surrey KT3 4QS,

United Kingdom

Coopermec 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Injectable Solution

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec for Cattle Swine and Sheep 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Super Solution for Injection

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Irlanda

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Panomec 1 % Solution for Injection for Cattle, Sheep and Pigs

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Classic Injection for Cattle and Sheep

1 % w/v

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Irlanda

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Fatromectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanimec Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec 1 % solution Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanectin Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Sumex Injection for Cattle, 1 %, Solution for injection for cattle

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Anisec Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Aniject Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chaniject Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Sumiject Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Medimec Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Topimec Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin 1,0 % w/v Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Mectaject 1,0 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bovimectin 1 % solution for injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injection for Cattle & Sheep

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Trimectin Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bovimec 1,0 % w/v Solution for Injection for Cattle

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Primectin 1 % w/v Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Solution for Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Enovex Injection 1 % w/v

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Irlanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closiver Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

L-Iżlanda

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec vet.

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Italja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Baymec 1 % Soluzione

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin cattle

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Italja

| INTERVET PRODUCTIONS SRL |
| --- |
| Via Nettunense km 20, 300 |
| 04011 Aprilia |
| Italy |

INTERVET PRODUCTIONS SRL

Via Nettunense km 20, 300

04011 Aprilia

Italy

Ivogell

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| Merial Italia S.p.A. a Socio Unico, |
| --- |
| Via Vittor Pisani, 16 |
| Milano |
| Italy |

Merial Italia S.p.A. a Socio Unico,

Via Vittor Pisani, 16

Milano

Italy

Ivomec

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| Merial Italia S.p.A. a Socio Unico, |
| --- |
| Via Vittor Pisani, 16 |
| Milano |
| Italy |

Merial Italia S.p.A. a Socio Unico,

Via Vittor Pisani, 16

Milano

Italy

Ivomec Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Italja

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec iniettable

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| Fatro |
| --- |
| Via Emilia, 285 |
| 40064 Ozzano Emilia (Bologna) |
| Italy |

Fatro

Via Emilia, 285

40064 Ozzano Emilia (Bologna)

Italy

Tolomec

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC Soluzione iniettabile

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Italja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC F Soluzione iniettabile

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Italja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Soluzione iniettabile per bovini

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

L-Italja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Divamectin 1 % Solution for Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Latvja

| Chanelle Pharmaceuticals Manufacturing Ltd., |
| --- |
| Loughrea, Co. Galway, |
| Ireland |

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 10 mg/ml

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC 1 % Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Il-Latvja

| Pharmaceutical Company |
| --- |
| PFO „VETOS-FARMA” sp. z.o.o., |
| Dzierzoniwska street 21 |
| 58-260 Bielawa |
| Poland |

Pharmaceutical Company

PFO „VETOS-FARMA” sp. z.o.o.,

Dzierzoniwska street 21

58-260 Bielawa

Poland

Iwermektyna 1 % Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Latvja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC PLUS, injekcinis tirpalas

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Litwanja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC 1 %, injekcinis tirpalas

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %, injekcinis tirpalas

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 %, injekcinis tirpalas

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injekcinis tirpalas

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| Invesa International S.A. |
| --- |
| Esmeralda 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

Invesa International S.A.

Esmeralda 19

08950 Esplugues de Llobregat

Barcelona

Spain

PROMECTINE

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited), |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda Chemical Export Ltd. (a division of Cross Vetpharm Group Limited),

Broomhill Road

Tallaght

Dublin 24

Ireland

BIMECTIN

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Litwanja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN 10 mg/ml

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Lussemburgu

| MERIAL Belgium S.A. |
| --- |
| Bld Sylvain Dupuis 243 |
| 1070 Bruxelles |
| Belgium |

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

Ivomec solution pour injection

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Lussemburgu

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Lussemburgu

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % inj.sol. bovine and porcine

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Lussemburgu

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin 1 % solution for injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Lussemburgu

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 1 % solution for injection

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Lussemburgu

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec solution pour injection bovine

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Malta

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Malta

| Laboratorios HIPRA S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer, Girona |
| Spain |

Laboratorios HIPRA S.A.

Avda. La Selva, 135

17170 Amer, Girona

Spain

Iveripra-I

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Malta

| Interchemie werken „de Adelaar” BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| The Netherlands |

Interchemie werken „de Adelaar” BV

Horsterweg 26A

5811 AC Castenray

The Netherlands

Intermectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Malta

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Malta

| INDUSTRIAL VETERINARIA, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

INDUSTRIAL VETERINARIA, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona

Spain

Promectine

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Olanda

| Merial B.V. |
| --- |
| Kleermakerstraat 10 |
| 1991 JL Velserbroek |
| The Netherlands |

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Ivomec

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Merial B.V. |
| --- |
| Kleermakerstraat 10 |
| 1991 JL Velserbroek |
| The Netherlands |

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Ivomec Plus

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Olanda

| Merial B.V. |
| --- |
| Kleermakerstraat 10 |
| 1991 JL Velserbroek |
| The Netherlands |

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Panomec Injectievloeistof

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec Injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Euromec Injectie

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Injectie

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injectie

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injectie

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin Cattle

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

L-Olanda

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin Injectie

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec F

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

L-Olanda

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ges-o-mec 10mg/ml oplossing voor injectie

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 10mg/g solution for injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Olanda

| Dopharma Research B.V. |
| --- |
| Zalmweg 24 |
| 4941 VX Raamsdonksveer |
| The Netherlands |

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Iverveto 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

In-Norveġja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec vet, injeksjonsvæske, oppløsning 10 mg/ml

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ċriev, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

In-Norveġja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Vet Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

In-Norveġja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC VET

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Vetoquinol Biowet Sp. z o.o., |
| --- |
| ul. Kosynierów Gdyńskich 13-14, |
| 66-400 Gorzów Wlkp., |
| Poland |

Vetoquinol Biowet Sp. z o.o.,

ul. Kosynierów Gdyńskich 13-14,

66-400 Gorzów Wlkp.,

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Ceva Sante Animale |
| --- |
| La Ballastiere |
| B.P. 126 |
| 33501 Libourne Cedex |
| France |

Ceva Sante Animale

La Ballastiere

B.P. 126

33501 Libourne Cedex

France

Cevamec 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A. |
| --- |
| ul. Grójecka 6 |
| 05-651 Drwalew |
| Poland |

Drwalewskie Zakłady Przemysłu Bioweterynaryjnego S.A.

ul. Grójecka 6

05-651 Drwalew

Poland

Ivermina 1 % Inj

Ivermectin 10 mg/ml

Frat, ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Pharmaceutical Company |
| --- |
| PFO „VETOS-FARMA” sp. z.o.o., |
| Dzierzoniwska street 21 |
| 58-260 Bielawa |
| Poland |

Pharmaceutical Company

PFO „VETOS-FARMA” sp. z.o.o.,

Dzierzoniwska street 21

58-260 Bielawa

Poland

Iwermektyna 1 % Iniekcja

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Agri- Biovet Sp. z o.o. |
| --- |
| ul. Smocza 27 |
| 01-048 Warsaw |
| Poland |

Agri- Biovet Sp. z o.o.

ul. Smocza 27

01-048 Warsaw

Poland

Pandex 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Scan Vet Poland Sp. z o.o. |
| --- |
| Skiereszewo, ul. Kiszkowska 9 |
| 62-200 Gniezno |
| Poland |

Scan Vet Poland Sp. z o.o.

Skiereszewo, ul. Kiszkowska 9

62-200 Gniezno

Poland

Paramectin 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Polonja

| Przedsiębiorstwo Wielobranżowe Vet Agro Sp. z o.o. |
| --- |
| ul. Gliniana 32 |
| 20-616 Lublin |
| Poland |

Przedsiębiorstwo Wielobranżowe Vet Agro Sp. z o.o.

ul. Gliniana 32

20-616 Lublin

Poland

Vetamectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Portugall

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Tizoval Bovinos 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Portugall

| Calier Portugal S.A |
| --- |
| Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro |
| Estrada de Albarraque |
| 2710 - 335 Sintra |
| Portugal |

Calier Portugal S.A

Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé de Mouro

Estrada de Albarraque

2710 - 335 Sintra

Portugal

Ivertin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Portugall

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Chanectin Injectável

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Portugall

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injectável para bovinos e ovinos 1 %

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Il-Portugall

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % Sol Injectável

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Portugall

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Vectimax 10 mg/Ml Sol. Inj.

Este é

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Portugall

| Merial Portuguesa - Saúde Animal, Lda |
| --- |
| AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas |
| 2635-432 Rio de Mouro |
| Portugal |

Merial Portuguesa - Saúde Animal, Lda

AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas

2635-432 Rio de Mouro

Portugal

Ivomec F

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Il-Portugall

| Merial Portuguesa - Saúde Animal, Lda |
| --- |
| AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas |
| 2635-432 Rio de Mouro |
| Portugal |

Merial Portuguesa - Saúde Animal, Lda

AV Maria Lamas, Lote 19 - BL - A Piso 2 Parque Industrial Comercial Serra das Minas

2635-432 Rio de Mouro

Portugal

Ivomec 1 % Bovinos, Solução Injectável

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Il-Portugall

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Injectável 1 %

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Portugall

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injectável 1 %

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Portugall

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec F, Solução Injectável

1mg/ml

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Il-Portugall

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC, Solução injectavel

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Il-Portugall

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin FF, solução injectável para bovinos

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Ir-Rumanija

| ANTIBIOTICE IASI S.A. |
| --- |
| Str. Valea Lupului, nr. 1, Iași, jud. Iași |
| Romania |

ANTIBIOTICE IASI S.A.

Str. Valea Lupului, nr. 1, Iași, jud. Iași

Romania

Ivermectina 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| BIOWET GORZOW PHARMACEUTICALS |
| --- |
| COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK |
| Poland |

BIOWET GORZOW PHARMACEUTICALS

COMPANY- Kosynierów Gdyńskich 13/14 ST., Gorzow WLPK

Poland

Biomectin 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| BIOVET JSC |
| --- |
| 39 Petar Rakov Str. |
| 4550 Pesthera |
| Bulgaria |

BIOVET JSC

39 Petar Rakov Str.

4550 Pesthera

Bulgaria

Pandex 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| Bioveta a.s., |
| --- |
| Komenského 212 |
| 683 23 Ivanovice na Hané |
| Czech Republic |

Bioveta a.s.,

Komenského 212

683 23 Ivanovice na Hané

Czech Republic

Biomec inj.

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| Bremer Pharma GmbH |
| --- |
| Cherbourger Str. 25 |
| 27540 Bremerhaven |
| Germany |

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| CEVA SANTE ANIMALE |
| --- |
| Str. Chindiei, nr. 5 |
| Sector 4 |
| 040185 București |
| Romania |

CEVA SANTE ANIMALE

Str. Chindiei, nr. 5

Sector 4

040185 București

Romania

Cevamec 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD. |
| --- |
| Jordan NA UR 11710 PO BOX 285 |
| Jordania |

DAR AL DAWA VETERINARY & AGRICULTURAL INDUSTRIAL Co. LTD.

Jordan NA UR 11710 PO BOX 285

Jordania

Ivodad 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| DUTCH FARM VETERINARY PHARMACEUTICALS |
| --- |
| B.V. |
| Veemweg 1-3771 MT BARNEVELEND |
| The Netherlands |

DUTCH FARM VETERINARY PHARMACEUTICALS

B.V.

Veemweg 1-3771 MT BARNEVELEND

The Netherlands

Dufamec 1 % inj.

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 1 % injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| FARMAVET S.A. |
| --- |
| Str. Petricani 198, |
| Chișinău |
| Republica Moldova |

FARMAVET S.A.

Str. Petricani 198,

Chișinău

Republica Moldova

Ivermectina 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| HEMOFARM – HEMOVET |
| --- |
| Beogradski Put BB |
| Vrsac |
| Serbia |

HEMOFARM – HEMOVET

Beogradski Put BB

Vrsac

Serbia

Ivermektin S

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| Laboratorios HIPRA S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer, Girona |
| Spain |

Laboratorios HIPRA S.A.

Avda. La Selva, 135

17170 Amer, Girona

Spain

Iveripra I

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| Interchemie werken „de Adelaar” BV |
| --- |
| Horsterweg 26A |
| 5811 AC Castenray |
| The Netherlands |

Interchemie werken „de Adelaar” BV

Horsterweg 26A

5811 AC Castenray

The Netherlands

Intermectin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| INTERVET PRODUCTIONS SRL |
| --- |
| Via Nettunense km 20, 300 |
| 04011 Aprilia |
| Italy |

INTERVET PRODUCTIONS SRL

Via Nettunense km 20, 300

04011 Aprilia

Italy

Ivogell

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| INTERVET ROMANIA S.R.L. |
| --- |
| Șoseaua de Centură, nr. 27-28, |
| 077040 Chiajna, Ilfov |
| Romania |

INTERVET ROMANIA S.R.L.

Șoseaua de Centură, nr. 27-28,

077040 Chiajna, Ilfov

Romania

Ivotan LA

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| PANTEX |
| --- |
| Ganzestaartsedijk 8 – 5525 KC Duizel |
| The Netherlands |

PANTEX

Ganzestaartsedijk 8 – 5525 KC Duizel

The Netherlands

Panmectin 10

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| PASTEUR – Filiala Filipești |
| --- |
| Str. Principală, nr. 944, Filipeștii de Pădure, |
| Jud. Prahova |
| Romania |

PASTEUR – Filiala Filipești

Str. Principală, nr. 944, Filipeștii de Pădure,

Jud. Prahova

Romania

Evomec

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| S.C. ROMVAC COMPANY S.A. |
| --- |
| Șos. Centurii, nr. 7, Voluntari |
| Romania |

S.C. ROMVAC COMPANY S.A.

Șos. Centurii, nr. 7, Voluntari

Romania

Romivermectin B1 1 %

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| SYVA |
| --- |
| Av. Párroco Pablo Diez, 49 – 57 |
| 24010 – Leon |
| Spain |

SYVA

Av. Párroco Pablo Diez, 49 – 57

24010 – Leon

Spain

Zoomectin

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Rumanija

| VMD Animal Health Ltd. |
| --- |
| Közraktár u. 22/b. II. 3., |
| 1093 Budapest |
| Hungary |

VMD Animal Health Ltd.

Közraktár u. 22/b. II. 3.,

1093 Budapest

Hungary

Iverveto 1 % Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| Vétoquinol s.r.o., |
| --- |
| Zámečnícka 411, |
| 288 02 Nymburk, |
| Czech Republic |

Vétoquinol s.r.o.,

Zámečnícka 411,

288 02 Nymburk,

Czech Republic

Biomectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| CEVA Animal Health Slovakia, spol. s r.o. |
| --- |
| Račianska 77 |
| 83 102 BRATISLAVA |
| Slovak Republic |

CEVA Animal Health Slovakia, spol. s r.o.

Račianska 77

83 102 BRATISLAVA

Slovak Republic

Cevamec 1 % inj. ad us. vet.

Ivermectin 10 mg/ml

Frat, Nagħaġ, Mogħoż, Ħnieżer

Subkutanju

| Frat, Nagħaġ, Mogħoż: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ, Mogħoż:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Injection ad us vet

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 % inj. ad us.vet.

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Super inj. ad us.vet.

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| Pharmagal spol. s.r.o. |
| --- |
| Murgašova 5 |
| 949 01 Nitra |
| Slovak Republic |

Pharmagal spol. s.r.o.

Murgašova 5

949 01 Nitra

Slovak Republic

Galmectin

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Repubblika Slovakka

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin injekčny roztok pre hovädzi dobytok

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Is-Slovenja

| VET4VET d.o.o. |
| --- |
| Gerbičeva 50, |
| 1000 Ljubljana |
| Slovenia |

VET4VET d.o.o.

Gerbičeva 50,

1000 Ljubljana

Slovenia

Animec Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Is-Slovenja

| VETERINA Plus d.o.o., Dunajska 51, |
| --- |
| 1000 Ljubljana, |
| Slovenia |

VETERINA Plus d.o.o., Dunajska 51,

1000 Ljubljana,

Slovenia

IVERKTIN 1 % solution for injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Is-Slovenja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC solution for injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Spain

| DIVASA FARMAVIC, S.A. |
| --- |
| Ctra. Sant Hipolit, km 71 |
| 08503 – Gurb-Vic |
| Barcelona |
| Spain |

DIVASA FARMAVIC, S.A.

Ctra. Sant Hipolit, km 71

08503 – Gurb-Vic

Barcelona

Spain

DIVAMECTIN 1 % SOLUCION

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Spanja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin 1 % Solution Inyectable para Bovino y Porcino

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Spanja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

VIRBAMEC SOLUCIÓN INYECTABLE PARA BOVINOS

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

TIZOVAL

VACUNO INYECTABLE

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

CHANECTIN INYECTABLE

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Inyectable

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Spanja

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

IVERTIN BOVINO

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| INDUSTRIAL VETERINARIA, S.A. |
| --- |
| C/ Esmeralda, 19 |
| 08950 Esplugues de Llobregat |
| Barcelona |
| Spain |

INDUSTRIAL VETERINARIA, S.A.

C/ Esmeralda, 19

08950 Esplugues de Llobregat

Barcelona

Spain

PROMECTINE

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

SUMEX INYECTABLE BOVINO

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| Laboratorios HIPRA S.A. |
| --- |
| Avda. La Selva, 135 |
| 17170 Amer, Girona |
| Spain |

Laboratorios HIPRA S.A.

Avda. La Selva, 135

17170 Amer, Girona

Spain

IVERIPRA-I

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

ECOMECTIN 10 MG/ML SOLUCION INYECTABLE

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Spanja

| Chemo Iberica |
| --- |
| Gran Vía Carlos III, 98 – 7oth floor. |
| 08028 Barcelona, |
| Spain |

Chemo Iberica

Gran Vía Carlos III, 98 – 7oth floor.

08028 Barcelona,

Spain

BOVECTIN

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| MERIAL LABORATORIOS S.A |
| --- |
| Tarragona, 161-Locales D/E |
| 08014 Barcelona |
| Spain |

MERIAL LABORATORIOS S.A

Tarragona, 161-Locales D/E

08014 Barcelona

Spain

Ivomec Inyectable Para Vacuno

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Spanja

| MERIAL LABORATORIOS S.A |
| --- |
| Tarragona, 161-Locales D/E |
| 08014 Barcelona |
| Spain |

MERIAL LABORATORIOS S.A

Tarragona, 161-Locales D/E

08014 Barcelona

Spain

Ivomec F Inyectable Para Vacuno

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Spanja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Solucion inyectable para bovino

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

L-Iżvezja

| MERIAL |
| --- |
| 29 avenue Tony Garnier |
| 69007 LYON |
| France |

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec® vet.

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Iżvezja

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2 |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2

2080-104 Almeirim

Portugal

Virbamec vet. 10 mg/ml injektionsvätska, lösning

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Iżvezja

| Bimeda (a division of Cross Vetpharm Group Limited) |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Bimeda (a division of Cross Vetpharm Group Limited)

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin® vet.

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Iżvezja

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin vet Solution for Injection 10mg/ml

Ivermectin 10 mg/ml

Frat, Ċriev, Ħnieżer

Subkutanju

| Frat, Ċriev: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Ċriev:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Iżvezja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin, 10 mg/ml, Injektionsvätska, lösning

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

L-Iżvezja

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec, 10 mg/ml, Injektionsvätska, lösning

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Laboratorios Calier SA |
| --- |
| Barcelones |
| 26 (Pla del Ramassa) |
| 08520 Les Franqueses del Valles |
| Barcelona |
| Spain |

Laboratorios Calier SA

Barcelones

26 (Pla del Ramassa)

08520 Les Franqueses del Valles

Barcelona

Spain

Ivertin Cattle

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Renju Unit

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Classic Injection for Cattle and Sheep

Ivermectin 10 mg/ml

Frat, Nagħaġ

Subkutanju

200 μg ivermectin/kg bw

Ir-Renju Unit

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Ivomec Super Injection for Cattle

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Ir-Renju Unit

| Merial Animal Health Limited |
| --- |
| Sandringham House |
| Harlow Business Park |
| Harlow |
| Essex CM19 5TG |
| United Kingdom |

Merial Animal Health Limited

Sandringham House

Harlow Business Park

Harlow

Essex CM19 5TG

United Kingdom

Panomec Injection for Cattle, Sheep and Pigs

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Chanelle Animal Health Ltd |
| --- |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec Injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Injectable Solution For Cattle and Swine

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Injectable Solution for Cattle, Swine and Sheep

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| VIRBAC DE PORTUGAL Laboratorios Lda |
| --- |
| Rua Dionísio Saraiva, Lote 1, |
| 1o Andar, Sala 2, |
| 2080-104 Almeirim |
| Portugal |

VIRBAC DE PORTUGAL Laboratorios Lda

Rua Dionísio Saraiva, Lote 1,

1o Andar, Sala 2,

2080-104 Almeirim

Portugal

Virbamec Super

Ivermectin 10 mg/ml,

Clorsulon 100 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 2 mg clorsulon/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Enovex Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Noromectin Multi Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Injection

Ivermectin 10 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Paramectin Multi Injection 1 % w/v Solution for Injection for Cattle, Sheep and Pigs

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin 1 % w/v Solution for Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Ecomec 1 % Injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Cross Vetpharm Group Ltd, |
| --- |
| Broomhill Road |
| Tallaght |
| Dublin 24 |
| Ireland |

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Qualimintic 1 % Injection

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Alstoe Ltd |
| --- |
| Sheriff Hutton Industrial Park |
| Sheriff Hutton |
| York |
| YO60 6RZ |
| United Kingdom |

Alstoe Ltd

Sheriff Hutton Industrial Park

Sheriff Hutton

York

YO60 6RZ

United Kingdom

Alstomec

Ivermectin 10 mg/ml

Frat, Ħnieżer

Subkutanju

| Frat: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Ecomectin 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| ECO Animal Health Ltd |
| --- |
| 78 Coombe Road |
| New Malden |
| Surrey KT3 4QS |
| United Kingdom |

ECO Animal Health Ltd

78 Coombe Road

New Malden

Surrey KT3 4QS

United Kingdom

Qualimec 10 mg/ml Solution for Injection

Ivermectin 10 mg/ml

Frat, Nagħaġ, Ħnieżer

Subkutanju

| Frat, Nagħaġ: | 200 μg ivermectin/kg bw |
| --- | --- |
| Ħnieżer: | 300 μg ivermectin/kg bw |

Frat, Nagħaġ:

200 μg ivermectin/kg bw

Ħnieżer:

300 μg ivermectin/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closamectin Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Closiver Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

Ir-Renju Unit

| Norbrook Laboratories Limited |
| --- |
| Station Works |
| Camlough Road |
| Newry BT35 6JP |
| Country Down |
| Northern Ireland |

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry BT35 6JP

Country Down

Northern Ireland

Norofas Solution for Injection

Ivermectin 5 mg/ml,

Closantel 125 mg/ml

Frat

Subkutanju

200 μg ivermectin/kg bw, 5 mg closantel/kg bw

---

ANNESS II

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | Janssen-Cilag Pharma GmbH |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Stat Membru EU/EEA

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

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 100 mg – Filmtabletten

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 200 mg - Filmtabletten

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 25 mg - Filmtabletten

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 50 mg - Filmtabletten

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 15 mg - Granulat in Kapseln

15 milligramma

Grani ġo kapsula

Użu Orali

L-Awstrija

| Janssen-Cilag Pharma GmbH |
| --- |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 25 mg - Granulat in Kapseln

25 milligramma

Grani ġo kapsula

Użu Orali

L-Awstrija

| Janssen-Cilag Pharma GmbH - |
| --- |
| Pfarrgasse 75 A-1232 Wien, L-Awstrija |

Janssen-Cilag Pharma GmbH -

Pfarrgasse 75 A-1232 Wien, L-Awstrija

Topamax 50 mg - Granulat in Kapseln

50 milligramma

Grani ġo kapsula

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 15mg harde capsules

15 milligramma

Kapsula, hard

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 25mg harde capsules

25 milligramma

Kapsula iebsa

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 50mg harde capsules

50 milligramma

Kapsula iebsa

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 100mg tabletten

100 milligramma

Pillola

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 200 mg tabletten

200 milligramma

Pillola

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 25 mg tabletten

25 milligramma

Pillola

Użu Orali

Il-Belġju

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 B-2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Il-Belġju

Topamax 50 mg tabletten

50 milligramma

Pillola

Użu Orali

Il-Bulgarija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja

TOPAMAX

15 milligramma

Kapsula

Użu Orali

Il-Bulgarija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja

TOPAMAX

25 milligramma

Kapsula

Użu Orali

Il-Bulgarija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja

TOPAMAX

100 milligramma

Pillola

Użu Orali

Il-Bulgarija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja

TOPAMAX

25 milligramma

Pillola

Użu Orali

Il-Bulgarija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI |
| --- |
| Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. - SI

Smartinska cesta 53, 1000 Ljubljana, Is-Slovenja

TOPAMAX

50 milligramma

Pillola

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 100 mg tabs

100 milligramma

Pillola

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 200 mg tabs

200 milligramma

Pillola

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 25 mg tabs

25 milligramma

Pillola miksija b'rita

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 50 mg tabs

50 milligramma

Pillola miksija b'rita

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 15 mg Sprinkles

15 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 25 mg Sprinkles

25 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Ċipru

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

TOPAMAX 50 mg Sprinkles

50 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Ir-Repubblika Ċeka

| Janssen-Cilag s.r.o – CZ |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o – CZ

Karla Engliše 3201/6

150 00 Praha 5

Topamax 100 mg

100 milligramma

Pillola miksija b'rita

Użu Orali

Ir-Repubblika Ċeka

| Janssen-Cilag s.r.o – CZ |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o – CZ

Karla Engliše 3201/6

150 00 Praha 5

Topamax 25 mg

25 milligramma

Pillola miksija b'rita

Użu Orali

Ir-Repubblika Ċeka

| Janssen-Cilag s.r.o – CZ |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o – CZ

Karla Engliše 3201/6

150 00 Praha 5

Topamax 50 mg

50 milligramma

Pillola miksija b'rita

Użu Orali

Ir-Repubblika Ċeka

| Janssen-Cilag s.r.o – CZ |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o – CZ

Karla Engliše 3201/6

150 00 Praha 5

Topamax 15 mg

15 milligramma

Kapsula

Użu Orali

Ir-Repubblika Ċeka

| Janssen-Cilag s.r.o – CZ |
| --- |
| Karla Engliše 3201/6 |
| 150 00 Praha 5 |

Janssen-Cilag s.r.o – CZ

Karla Engliše 3201/6

150 00 Praha 5

Topamax 25 mg

25 milligramma

Kapsula

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

15 milligramma

Kapsula iebsa

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

25 milligramma

Kapsula iebsa

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

50 milligramma

Kapsula iebsa

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

100 milligramma

Pillola miksija b'rita

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

200 milligramma

Pillola miksija b'rita

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

25 milligramma

Pillola miksija b'rita

Użu Orali

Id-Danimarka

| Janssen-Cilag A/S - DK |
| --- |
| Hammerbakken 19, 3460 Birkerød, Id-Danimarka |

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Id-Danimarka

Topimax

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Estonja

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Il-Litwanja |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Il-Litwanja

TOPAMAX 100 mg

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Estonja

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Il-Litwanja |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Il-Litwanja

TOPAMAX 200 mg

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Estonja

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Il-Litwanja |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Il-Litwanja

TOPAMAX 25 mg

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Estonja

| UAB Johnson & Johnson - LT |
| --- |
| Geležinio Vilko g. 18A |
| LT-08104 Vilnius |
| Il-Litwanja |

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Il-Litwanja

TOPAMAX 50 mg

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 15 mg kapseli, kova

15 milligramma

Kapsula iebsa

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 100 mg tabletti, kalvopäällysteinen

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 200 mg tabletti, kalvopäällysteinen

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 25 mg tabletti, kalvopäällysteinen

25 milligramma

Pillola miksija b'rita

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 50 mg tabletti, kalvopäällysteinen

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 25 mg kapseli, kova

25 milligramma

Kapsula iebsa

Użu Orali

Il-Finlandja

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Il-Finlandja |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Il-Finlandja

Topimax 50 mg kapseli, kova

50 milligramma

Kapsula, hard

Użu Orali

Franza

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza

EPITOMAX 100 mg, COMPRIME PELLICULE

100 milligramma

Pillola miksija b'rita

Użu Orali

Franza

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza

EPITOMAX 200 mg, COMPRIME PELLICULE

200 milligramma

Pillola miksija b'rita

Użu Orali

Franza

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza

EPITOMAX 50 mg, COMPRIME PELLICULE

50 milligramma

Pillola miksija b'rita

Użu Orali

Franza

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza

EPITOMAX 15 mg, GELULE

15 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Franza

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza

EPITOMAX 25 mg, GELULE

25 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Franza

| Janssen-Cilag S.A. – FR |
| --- |
| 1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza |

Janssen-Cilag S.A. – FR

1 rue Camille Desmoulins, TSA 91003, 92787 ISSY-Les-Moulineaux Cedex 9 Franza

EPITOMAX 50 mg, GELULE

50 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Cilag 25 mg Hartkapseln

25 milligramma

Kapsula iebsa

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Janssen 25 mg Hartkapseln

25 milligramma

Kapsula iebsa

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Cilag 50 mg Hartkapseln

50 milligramma

Kapsula iebsa

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Janssen 50 mg Hartkapseln

50 milligramma

Kapsula iebsa

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topamax 100 mg Filmtabletten

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Janssen 100 mg Filmtabletten

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

TOPAMAX MIGRÄNE 100 mg Filmtabletten

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat - Cilag 100 mg Filmtabletten

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Cilag 100 mg Filmtabletten

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topamax 200 mg Filmtabletten

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

TOPAMAX MIGRÄNE 200 mg Filmtabletten

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat - Cilag 200 mg Filmtabletten

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Cilag 200 mg Filmtabletten

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Janssen 200 mg Filmtabletten

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topamax 25 mg Filmtabletten

25 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

TOPAMAX MIGRÄNE 25 mg Filmtabletten

25 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Cilag 25 mg Filmtabletten

25 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Janssen 25 mg Filmtabletten

25 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topamax 50 mg Filmtabletten

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

TOPAMAX MIGRÄNE 50 mg Filmtabletten

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Cilag 50 mg Filmtabletten

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topiramat-Janssen 50 mg Filmtabletten

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topamax 25 mg Kapseln

25 milligramma

Kapsula iebsa

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

TOPAMAX MIGRÄNE 25 mg Hartkapseln

25 milligramma

Kapsula

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

Topamax 50 mg Kapseln

50 milligramma

Kapsula iebsa

Użu Orali

Il-Ġermanja

| Janssen-Cilag GmbH - DE |
| --- |
| Raiffeisenstr. 8 |
| 41470 Neuss, Il-Ġermanja |

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Il-Ġermanja

TOPAMAX MIGRÄNE 50 mg Hartkapseln

50 milligramma

Kapsula

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

100 milligramma

Pillola miksija b'rita

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

200 milligramma

Pillola miksija b'rita

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

25 milligramma

Pillola miksija b'rita

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

50 milligramma

Pillola miksija b'rita

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

15 milligramma

Kapsula iebsa

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

25 milligramma

Kapsula iebsa

Użu Orali

Il-Greċja

| Janssen-Cilag Pharmaceutical S.A.C.I. – GR |
| --- |
| 56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja |

Janssen-Cilag Pharmaceutical S.A.C.I. – GR

56 Eirinis Avenue 56, Pefki, 15121, Il-Ġreċja

TOPAMAC

50 milligramma

Kapsula iebsa

Użu Orali

L-Ungerija

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, L-Ungerija |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, L-Ungerija

Topamax 100 mg film-coated tablet

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Ungerija

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, L-Ungerija |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, L-Ungerija

Topamax 200 mg film-coated tablets

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Ungerija

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, L-Ungerija |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, L-Ungerija

Topamax 25 mg film-coated tablet

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Ungerija

| Janssen-Cilag Kft. - HU |
| --- |
| 2045 Törökbálint Tó park, L-Ungerija |

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, L-Ungerija

Topamax 50 mg film-coated tablet

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 15 mg hylki, hörð

15 milligramma

Kapsula iebsa

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 25 mg hylki, hörð

25 milligramma

Kapsula iebsa

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 50 mg hylki, hörð

50 milligramma

Kapsula iebsa

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 100 mg filmuhúðaðar töflur

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 200 mg filmuhúðaðar töflur

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 25 mg filmuhúðaðar töflur

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Islanda

| Janssen-Cilag AB - SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 50 mg filmuhúðaðar töflur

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX 100 mg Tablets

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX 200 mg Tablets

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX 25 mg Tablets

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX 50 mg Tablets

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX Sprinkle Capsules 15 mg.

15 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX Sprinkle Capsules 25 mg.

25 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

L-Irlanda

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Ir-Renju Unit

TOPAMAX Sprinkle Capsules 50 mg

50 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 15 mg capsule rigide, 60 capsule

15 milligramma

Kapsula iebsa

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 100 mg compresse rivestite con film, 60 compresse

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

EPITOMAX 100 mg compresse rivestite con film, 60 compresse

100 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 200 mg compresse rivestite con film, 60 compresse

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

EPITOMAX 200 mg compresse rivestite con film, 60 compresse

200 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 25 mg compresse rivestite con film, 60 compresse

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

EPITOMAX 25 mg compresse rivestite con film, 60 compresse

25 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

TOPAMAX 300 mg compresse rivestite con film, 60 compresse

300 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

EPITOMAX 300 mg compresse rivestite con film, 60 compresse

300 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 400 mg compresse rivestite con film, 60 compresse

400 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

EPITOMAX 400 mg compresse rivestite con film, 60 compresse

400 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 50 mg compresse rivestite con film, 60 compresse

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| J.C. Healthcare srl – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, |
| L-Italja |

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

L-Italja

EPITOMAX 50 mg compresse rivestite con film, 60 compresse

50 milligramma

Pillola miksija b'rita

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 25 mg capsule rigide, 60 capsule

25 milligramma

Kapsula iebsa

Użu Orali

L-Italja

| Janssen-Cilag SpA – IT |
| --- |
| Via Michelangelo Buonarroti n. 23 |
| Cologno Monzese, 20093, Milano, L-Italja |

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, L-Italja

TOPAMAX 50 mg capsule rigide, 60 capsule

50 milligramma

Kapsula iebsa

Użu Orali

Il-Latvja

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja

Topamax 100 mg coated tablets

100 milligramma

Pillola miksija

Użu Orali

Il-Latvja

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja

Topamax 25 mg coated tablets

25 milligramma

Pillola miksija

Użu Orali

Il-Latvja

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja

Topamax 50 mg coated tablets

50 milligramma

Pillola miksija

Użu Orali

Il-Latvja

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja

Topamax 15 mg sprinkle capsules

15 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Il-Latvja

| UAB Johnson & Johnson - LT |
| --- |
| Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Il-Litwanja

Topamax 25 mg sprinkle capsules

25 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja

Topamax

100 milligramma

Pillola

Użu Orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja

Topamax

200 milligramma

Pillola

Użu Orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja

Topamax

25 milligramma

Pillola

Użu Orali

Il-Litwanja

| UAB Johnson & Johnson |
| --- |
| Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja |

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Il-Litwanja

Topamax

50 milligramma

Pillola

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax gélules 15 mg

15 milligramma

Kapsula iebsa

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax comprimés 100 mg

100 milligramma

Kapsula

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax comprimés 200 mg

200 milligramma

Pillola

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax comprimés 25 mg

25 milligramma

Pillola

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax comprimés 50 mg

50 milligramma

Pillola

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax gélules 25 mg

25 milligramma

Kapsula iebsa

Użu Orali

Il-Lussemburgu

| Janssen-Cilag NV – BE |
| --- |
| Roderveldlaan 1 2600 Berchem, Il-Belġju |

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Il-Belġju

Topamax gélules 50 mg

50 milligramma

Kapsula iebsa

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

100 milligramma

Pillola

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

200 milligramma

Pillola

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

25 milligramma

Pillola

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

50 milligramma

Pillola

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

15 milligramma

Kapsula iebsa

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

25 milligramma

Kapsula iebsa

Użu Orali

Malta

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30, B-2340 Beerse, Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Il-Belġju

Topamax

50 milligramma

Kapsula iebsa

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax omhulde tabletten 100 mg, omhulde tabletten

100 milligramma

Pillola miksija

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax omhulde tabletten 200 mg, omhulde tabletten

200 milligramma

Pillola Miksija

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax omhulde tabletten 25 mg, omhulde tabletten

25 milligramma

Pillola Miksija

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax omhulde tabletten 50 mg, omhulde tabletten

50 milligramma

Pillola Miksija

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax Sprinkle capsules 15 mg, capsules

15 milligramma

Kapsula

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax Sprinkle capsules 25 mg, capsules

25 milligramma

Kapsula

Użu Orali

L-Olanda

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| L-Olanda |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

L-Olanda

Topamax Sprinkle capsules 50 mg, capsules

50 milligramma

Kapsula

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 15 mg Kapsel, hard

15 milligramma

Kapsula iebsa

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 25 mg Kapsel, hard

25 milligramma

Kapsula iebsa

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 50 mg Kapsel, hard

50 milligramma

Kapsula iebsa

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 100 mg Tabletter filmdrasjert

100 milligramma

Pillola miksija b’rita

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 200 mg Tabletter filmdrasjert

200 milligramma

Pillola miksija b’rita

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 25 mg Tabletter filmdrasjert

25 milligramma

Pillola miksija b’rita

Użu Orali

In-Norveġja

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo In-Norveġja |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo In-Norveġja

Topimax 50 mg Tabletter filmdrasjert

50 milligramma

Pillola miksija b’rita

Użu Orali

Il-Polonja

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Il-Belġju

Topamax 100 mg tabletki powlekane

100 milligramma

Pillola miksija b’rita

Użu Orali

Il-Polonja

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Il-Belġju

Topamax 200 mg tabletki powlekane

200 milligramma

Pillola miksija b’rita

Użu Orali

Il-Polonja

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Il-Belġju

Topamax 25 mg tabletki powlekane

25 milligramma

Pillola miksija b’rita

Użu Orali

Il-Polonja

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Il-Belġju

Topamax 50 mg tabletki powlekane

50 milligramma

Pillola miksija b’rita

Użu Orali

Il-Polonja

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Il-Belġju

Topamax , 15 mg kapsulki

15 milligramma

Kapsula

Użu Orali

Il-Polonja

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Il-Belġju |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Il-Belġju

Topamax , 25 mg kapsulki

25 milligramma

Kapsula

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

100 milligramma

Pillola miksija b’rita

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

200 milligramma

Pillola miksija b’rita

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

25 milligramma

Pillola miksija b’rita

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

50 milligramma

Pillola miksija b’rita

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

15 milligramma

Kapsula iebsa

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

25 milligramma

Kapsula iebsa

Użu Orali

Il-Portugall

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Il-Portugall

Topamax

50 milligramma

Kapsula iebsa

Użu Orali

Ir-Rumanija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Is-Slovenja |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Is-Slovenja

TOPAMAX 100 tablets

100 milligramma

Pillola

Użu Orali

Ir-Rumanija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Is-Slovenja |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Is-Slovenja

TOPAMAX 200 tablets

200 milligramma

Pillola

Użu Orali

Ir-Rumanija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Is-Slovenja |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Is-Slovenja

TOPAMAX 25 tablets

25 milligramma

Pillola

Użu Orali

Ir-Rumanija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Is-Slovenja |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Is-Slovenja

TOPAMAX 50 tablets

50 milligramma

Pillola

Użu Orali

Ir-Rumanija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Is-Slovenja |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Is-Slovenja

TOPAMAX sprinkle caps

50 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Is-Slovakkja

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Is-Slovakkja |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Is-Slovakkja

Topamax 15 mg cps

15 milligramma

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu Orali

Is-Slovakkja

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Is-Slovakkja |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Is-Slovakkja

Topamax 25 mg cps

25 milligramma

Kapsula li terħi l-mediċina bil-mod, iebsa

Użu Orali

Is-Slovakkja

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Is-Slovakkja |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Is-Slovakkja

Topamax 100

100 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovakkja

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Is-Slovakkja |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Is-Slovakkja

Topamax 200

200 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovakkja

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Is-Slovakkja |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Is-Slovakkja

Topamax 25

25 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovakkja

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Is-Slovakkja |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Is-Slovakkja

Topamax 50

50 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovenja

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Is-Slovenja

TOPAMAX 100 mg filmsko oblozene tablete

100 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovenja

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Is-Slovenja

TOPAMAX 200 mg filmsko oblozene tablete

200 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovenja

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Is-Slovenja

TOPAMAX 25 mg filmsko oblozene tablete

25 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovenja

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Is-Slovenja

TOPAMAX 50 mg filmsko oblozene tablete

50 milligramma

Pillola miksija b’rita

Użu Orali

Is-Slovenja

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Is-Slovenja |

Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI

Šmartinska 53, Ljubljana, Is-Slovenja

TOPAMAX 15 mg kapsule

15 milligramma

Kapsula iebsa

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX 100 mg Comprimidos recubiertos

100 milligramma

Pillola miksija

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX 200 mg Comprimidos recubiertos

200 milligramma

Pillola miksija

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX 25 mg Comprimidos recubiertos

25 milligramma

Pillola miksija

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX 50 mg Comprimidos recubiertos

50 milligramma

Pillola miksija

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX DISPERSABLE 15 mg, cápsulas

15 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX DISPERSABLE 25 mg, cápsulas

25 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Spanja

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja

TOPAMAX DISPERSABLE 50 mg, cápsulas

50 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 15 mg kapslar, hårda

15 milligramma

Kapsula iebsa

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 25 mg kapslar, hårda

25 milligramma

Kapsula iebsa

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 50 mg kapslar, hårda

50 milligramma

Kapsula iebsa

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 100 mg tabletter, filmdragerade

100 milligramma

Pillola miksija b’rita

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 200 mg tabletter, filmdragerade

200 milligramma

Pillola miksija b’rita

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 25 mg tabletter, filmdragerade

25 milligramma

Pillola miksija b’rita

Użu Orali

L-Isvezja

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, L-Isvezja |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, L-Isvezja

Topimax 50 mg tabletter, filmdragerade

50 milligramma

Pillola miksija b’rita

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX 100 mg Tablets

100 milligramma

Pillola

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX 200 mg Tablets

200 milligramma

Pillola

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX 25 mg Tablets

25 milligramma

Pillola

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX 50 mg Tablets

50 milligramma

Pillola

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX Sprinkle Capsules 15 mg

15 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX Sprinkle Capsules 25 mg

25 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

Ir-Renju Unit

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Ir-Renju Unit |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Ir-Renju Unit

TOPAMAX Sprinkle Capsules 50 mg

50 milligramma

Kapsula li tista tiftaħha u troxxha

Użu Orali

---

ANNESS III

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | L-Applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| 1160 Wien |
| L-Awstrija |

Stat Membru UE/EEA

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

L-Applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut

(Konċentrat)

L-Awstrija

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

L-Awstrija

Avelox 400 mg - Infusionslösung

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Belġju

| Bayer SA-NV |
| --- |
| Avenue Louise 143 Louizalaan |
| B-1050 Brussel |
| Il-Belġju |

Bayer SA-NV

Avenue Louise 143 Louizalaan

B-1050 Brussel

Il-Belġju

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Ċipru

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| 151 25 Marousi - Athens |
| Il-Greċja |

Bayer Hellas S.A.

Sorou 18-20

151 25 Marousi - Athens

Il-Greċja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Ir-Repubblika Ċeka

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox 400 mg/250 ml infuzní roztok

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Id-Danimarka

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Estonja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Finlandja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Franza

| Bayer Santé |
| --- |
| 13, rue Jean Jaurès |
| 92807 Puteaux Cedex |
| Franza |

Bayer Santé

13, rue Jean Jaurès

92807 Puteaux Cedex

Franza

Izilox 400 mg / 250 ml, solution pour perfusion

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Ġermanja

| Bayer Vital GmbH |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer Vital GmbH

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avalox 400 mg/250 ml Infusionslösung

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Greċja

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| 151 25 Marousi - Athens |
| Il-Greċja |

Bayer Hellas S.A.

Sorou 18-20

151 25 Marousi - Athens

Il-Greċja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Ungerija

| Bayer Hungária Kft |
| --- |
| Alkotás ut.50 |
| 1123 Budapest |
| L-Ungerija |

Bayer Hungária Kft

Alkotás ut.50

1123 Budapest

L-Ungerija

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Irlanda

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road, |
| Dublin 18 |
| L-Irlanda |

Bayer Limited

The Atrium

Blackthorn Road,

Dublin 18

L-Irlanda

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Italja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avalox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Latvja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Litwanja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Lussemburgu

| Bayer SA-NV |
| --- |
| Avenue Louise 143 Louizalaan |
| B-1050 Brussel |
| Il-Belġju |

Bayer SA-NV

Avenue Louise 143 Louizalaan

B-1050 Brussel

Il-Belġju

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Malta

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avalox 400 mg/250 ml Soluzzjoni għall-infużjoni

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Olanda

| Bayer BV |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| L-Olanda |

Bayer BV

Energieweg 1

3641 RT Mijdrecht

L-Olanda

Avelox 400 mg/250 ml oplossing voor infusie

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Polonja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Portugall

| BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda. |
| --- |
| Rua Quinta do Pinheiro, 5 |
| 2794-003 Carnaxide |
| Il-Portugall |

BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Il-Portugall

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

ls-Slovakkja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox 400 mg/250 ml infúzny roztok

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Is-Slovenja

| BAYER d.o.o. |
| --- |
| Bravničarjeva 13 |
| 1000 Ljubljana |
| Is-Slovenja |

BAYER d.o.o.

Bravničarjeva 13

1000 Ljubljana

Is-Slovenja

Avelox 400 mg/250 ml raztopina za infundiranje

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Spanja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Muzolil

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Isvezja

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Il-Ġermanja

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Ir-Renju Unit

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| Ir-Renju Unit |

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

Ir-Renju Unit

Avelox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

---

ANNESS IV

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | L-Applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut
  (Konċetrat) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| 1160 Wien |
| L-Awstrija |

Stat Membru UE/EEA

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

L-Applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut

(Konċetrat)

L-Awstrija

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

L-Awstrija

Octegra 400 mg - Infusionslösung

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Belġju

| Bayer Austria GmbH |
| --- |
| Herbststraße 6-10 |
| 1160 Wien |
| L-Awstrija |

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

L-Awstrija

Proflox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Franza

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

51368 Leverkusen

Il-Ġermanja

Octegra 400 mg / 250 ml, solution pour perfusion

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Ġermanja

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

51368 Leverkusen

Il-Ġermanja

Octegra 400 mg / 250 ml Infusionslösung

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Greċja

| Elpen Pharmaceutical Co, Inc |
| --- |
| 95, Marathonos Avenue |
| 190-09 Pikermi |
| Il-Greċja |

Elpen Pharmaceutical Co, Inc

95, Marathonos Avenue

190-09 Pikermi

Il-Greċja

Octegra

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Lussemburgu

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

51368 Leverkusen

Il-Ġermanja

Proflox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

L-Olanda

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Il-Ġermanja |

Bayer HealthCare AG

51368 Leverkusen

Il-Ġermanja

Octegra 400 mg/250 ml oplossing voor infusie

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

Il-Portugall

| Bialfar - Produtos Farmacêuticos S.A. |
| --- |
| À Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| Il-Portugall |

Bialfar - Produtos Farmacêuticos S.A.

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Il-Portugall

Proflox

400 mg

Soluzzjoni għall-infużjoni

Użu għal ġol-vini

400 mg / 250 ml

---

ANNESS V

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIKA, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANTI, ID-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru UE/ŻEE | Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fissuq | L-Applikant | Isem Ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | | Helm Pharmaceuticals GmbH |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Stat Membru UE/ŻEE

Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fissuq

L-Applikant

Isem Ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 25 Mikrogramm/h Transdermales Pflaster

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Awstrija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 50 Mikrogramm/h Transdermales Pflaster

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Awstrija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 75 Mikrogramm/h Transdermales Pflaster

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Awstrija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 100 Mikrogramm/h Transdermales Pflaster

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Belġju

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm Pharmaceuticals 25 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Belġju

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm Pharmaceuticals 50 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Belġju

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm Pharmaceuticals 75 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Belġju

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm Pharmaceuticals 100 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Ġermanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 25 μ/h Transdermales Pflaster

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Ġermanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 50 μ/h Transdermales Pflaster

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Ġermanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 75 μ/h Transdermales Pflaster

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Ġermanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 100 μ/h Transdermales Pflaster

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Italja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 25 μg/h cerotto transdermico

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Italja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 50 μg/h cerotto transdermico

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Italja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 75 μg/h cerotto transdermico

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

L-Italja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanyl Helm 100 μg/h cerotto transdermico

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Olanda

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 25 μg/h Pleister voor transderaal gebruik

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Olanda

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 50 μg/h Pleister voor transderaal gebruik

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Olanda

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 75 μg/h Pleister voor transderaal gebruik

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Olanda

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentrix 100 μg/h Pleister voor transderaal gebruik

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Portugall

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Helm

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Portugall

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Helm

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Portugall

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Helm

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Il-Portugall

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Helm

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Is-Slovenja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanil HELM 25 mikrogramov/h transdermalni obliži

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Is-Slovenja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanil HELM 50 mikrogramov/h transdermalni obliži

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Is-Slovenja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanil HELM 75 mikrogramov/h transdermalni obliži

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Is-Slovenja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanil HELM 100 mikrogramov/h transdermalni obliži

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Spanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Matrix Helm 25 microgramos/hora parches transdérmicos EFG

25 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Spanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Matrix Helm 50 microgramos/hora parches transdérmicos EFG

50 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Spanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Matrix Helm 75 microgramos/hora parches transdérmicos EFG

75 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

Spanja

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Ġermanja |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Ġermanja

Fentanilo Matrix Helm 100 microgramos/hora parches transdérmicos EFG

100 μg/h

Impjastru li jgħaddi il-mediċina mill-ġilda

użu transdermali

---

ANNESS VI

LISTA TA' L-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, L-APPLIKANT, ID-DETENTUR TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU/EEA | Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem ivvintat | Qawwa | Għamla Farmaċewtika | Mnjen jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | AstraZeneca Österreich GmbH, |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| L-Awstrija |

Stat Membru EU/EEA

Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq

Isem ivvintat

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

Il-Kontenut

(Konċentrat)

L-Awstrija

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7

A-1037 Wien

L-Awstrija

Optinem i.v. 500 mg - Trockenstechampullen

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20ml

L-Awstrija

| AstraZeneca Österreich GmbH, |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| L-Awstrija |

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7

A-1037 Wien

L-Awstrija

Optinem i.v. 1 g - Trockenstechampullen

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g /30 ml

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Il-Belġju |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel

Il-Belġju

Meronem IV 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Belġju

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Il-Belġju |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel

Il-Belġju

Meronem IV 1 g

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Il-Bulgarija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Bulgarija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Ċipru

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

MERONEM

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Ċipru

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

MERONEM

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Ir-Repubblika Ċeka

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

MERONEM

500 mg

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

500 mg/20 ml

Ir-Repubblika Ċeka

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

MERONEM

1 g

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

1 g/30 ml

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Id-Danimarka |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Id-Danimarka

MERONEM

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Id-Danimarka

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Id-Danimarka |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Id-Danimarka

MERONEM

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Estonja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Ir-Renju Unit |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Ir-Renju Unit

Meronem

500mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/10 ml

L-Estonja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Ir-Renju Unit |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Ir-Renju Unit

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/20 ml

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Il-Finlandja |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Il-Finlandja

Meronem 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Finlandja

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Il-Finlandja |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Il-Finlandja

Meronem 1 g

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Franza

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON Cédex |
| Franza |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cédex

Franza

MERONEM

500 mg poudre pour solution injectable IV

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Franza

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON Cédex |
| Franza |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cédex

Franza

MERONEM

1 g poudre pour solution injectable IV

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Il-Ġermanja

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postal 22876 Wedel |
| Il-Ġermanja |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postal 22876 Wedel

Il-Ġermanja

Meronem 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/10 ml

5 mg / ml

Il-Ġermanja

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postal 22876 Wedel |
| Il-Ġermanja |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postal 22876 Wedel

Il-Ġermanja

Meronem 1 000 mg

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/20 ml

5 mg / ml

Il-Greċja

| CANA Pharmaceutical Laboratories Societe Anonyme |
| --- |
| 446 Irakliou Ave. |
| GR-141 22 Iraklion Attikis, |
| Il-Greċja |

CANA Pharmaceutical Laboratories Societe Anonyme

446 Irakliou Ave.

GR-141 22 Iraklion Attikis,

Il-Greċja

Meronem

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Greċja

| CANA Pharmaceutical Laboratories Societe Anonyme |
| --- |
| 446 Irakliou Ave |
| GR-141 22 Iraklion Attikis, |
| Il-Greċja |

CANA Pharmaceutical Laboratories Societe Anonyme

446 Irakliou Ave

GR-141 22 Iraklion Attikis,

Il-Greċja

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Ungerija

| AstraZeneca Kft.- Hungary |
| --- |
| H-2045 Törökbálint |
| Park u. 3. |
| L-Ungerija |

AstraZeneca Kft.- Hungary

H-2045 Törökbálint

Park u. 3.

L-Ungerija

Meronem 500 mg intravenas injekcio

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

L-Ungerija

| AstraZeneca Kft. - Hungary |
| --- |
| H-2045 Törökbálint |
| Park u. 3. |
| L-Ungerija |

AstraZeneca Kft. - Hungary

H-2045 Törökbálint

Park u. 3.

L-Ungerija

Meronem 1 g intravenas injekcio

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Islanda

| AstraZeneca UK Ltd. |
| --- |
| Alderley Park |
| Macclesfield |
| Cheshire SK10 4TF |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Alderley Park

Macclesfield

Cheshire SK10 4TF

Ir-Renju Unit

Meronem 500 mg stungulyfs-/ innrennslisstofn, lausn.

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

L-Islanda

| AstraZeneca UK Ltd. |
| --- |
| Alderley Park |
| Macclesfield |
| Cheshire SK10 4TF |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Alderley Park

Macclesfield

Cheshire SK10 4TF

Ir-Renju Unit

Meronem 1 g stungulyfs-/innrennslisstofn, lausn.

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Irlanda

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem IV 0,5 g powder for solution for injection or infusion.

0,5 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

L-Irlanda

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem IV 1 g powder for solution for injection or infusion.

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 500 mg polvere per soluzione iniettabile per uso endovenoso

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 1 000 mg polvere per soluzione iniettabile per uso endovenoso

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 500 mg polvere e solvente per soluzione iniettabile per uso intramuscolare

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/2 ml

(mhux fuq is-suq)

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 250 mg polvere e solvente per soluzione iniettabile per uso endovenoso

250 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

250 mg/5 ml

(mhux fuq is-suq)

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 500 mg polvere e solvente per soluzione iniettabile per uso endovenoso

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/10 ml

(mhux fuq is-suq)

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 1 000 mg polvere e solvente per soluzione iniettabile per uso endovenoso

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/20 ml

(mhux fuq is-suq)

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 250 mg polvere e solvente per soluzione per infusione

250 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

250 mg/100 ml

(mhux fuq is-suq)

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 500 mg polvere e solvente per soluzione per infusione

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/100 ml

(mhux fuq is-suq)

L-Italja

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| L-Italja |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

L-Italja

MERREM 1 000 mg polvere e solvente per soluzione per infusione

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/100 ml

(not marketed)

Il-Latvja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Latvja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem 1 g

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Il-Litwanja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem IV

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/10 ml

Il-Litwanja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem IV

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/20 ml

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel, |
| Il-Belġju |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel,

Il-Belġju

Meronem IV 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Lussemburgu

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel, |
| Il-Belġju |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel,

Il-Belġju

Meronem IV 1 g

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem IV 0,5 g powder for solution for injection or infusion.

0,5 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem IV 1 g powder for solution for injection or infusion.

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, |
| L-Olanda |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE, Zoetermeer,

L-Olanda

Meronem i.v.

250 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

Fil-proċess sabiex tiġi kkanċellata

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, |
| L-Olanda |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE, Zoetermeer,

L-Olanda

Meronem i.v.

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

L-Olanda

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, |
| L-Olanda |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE, Zoetermeer,

L-Olanda

Meronem i.v.

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

In-Norveġja

| AstraZeneca AS |
| --- |
| Hoffsveien 70 |
| B/Postboks 200 |
| Vinderen |
| 0319 OSLO |
| In-Norveġja |

AstraZeneca AS

Hoffsveien 70

B/Postboks 200

Vinderen

0319 OSLO

In-Norveġja

Meronem

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

In-Norveġja

| AstraZeneca AS |
| --- |
| Hoffsveien 70 |
| B/Postboks 200 |
| Vinderen |
| 0319 OSLO |
| In-Norveġja |

AstraZeneca AS

Hoffsveien 70

B/Postboks 200

Vinderen

0319 OSLO

In-Norveġja

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Il-Polonja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Polonja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, |
| n.o 7, Valejas |
| 2745-663 Barcarena, Il-Portugall |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira,

n.o 7, Valejas

2745-663 Barcarena, Il-Portugall

Meronem

500 mg

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-muskoli

500 mg/2 ml

(mhux fis-suq)

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, |
| n.o 7, Valejas |
| 2745-663 Barcarena, Il-Portugall |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira,

n.o 7, Valejas

2745-663 Barcarena, Il-Portugall

Meronem

500 mg

Trab għal soluzzjoni għall- infużjoni

Użu għal ġol-vini

500 mg/20 ml

Il-Portugall

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, |
| n.o 7, Valejas |
| 2745-663 Barcarena, Il-Portugall |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira,

n.o 7, Valejas

2745-663 Barcarena, Il-Portugall

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Ir-Rumanija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| United Kingdom |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

United Kingdom

Meronem i.v. 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Ir-Rumanija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem i.v. 1 g

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

Is-Slovakkja

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Ir-Renju Unit |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Ir-Renju Unit

Meronem 500 mg i.v.

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Is-Slovenja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Ir-Renju Unit |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Ir-Renju Unit

Meronem 500 mg prasek za raztopino za injiciranje ali infundiranje

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

50 mg/ml

Is-Slovenja

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Ir-Renju Unit |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Ir-Renju Unit

Meronem 1 g prasek za raztopino za injiciranje ali infundiranje

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

50 mg/ml

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache |
| 56 Edificio Roble |
| 28033 Madrid |
| Spanja |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache

56 Edificio Roble

28033 Madrid

Spanja

Meronem I.V., 500

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Spanja

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache |
| 56 Edificio Roble |
| 28033 Madrid |
| Spanja |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache

56 Edificio Roble

28033 Madrid

Spanja

Meronem I.V., 1 000

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

L-Isvezja

| AstraZeneca AB |
| --- |
| S-15185 Södertälje |
| L-Isvezja |

AstraZeneca AB

S-15185 Södertälje

L-Isvezja

Meronem

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/10 ml

għall-injezzjoni jew konċentrazzjoni varjabbli għall-infużjoni

L-Isvezja

| AstraZeneca AB |
| --- |
| S-15185 Södertälje |
| L-Isvezja |

AstraZeneca AB

S-15185 Södertälje

L-Isvezja

Meronem

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/20 ml

għall-injezzjoni jew konċentrazzjoni varjabbli għall-infużjoni

Ir-Renju Unit

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem IV 500 mg

500 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg/20 ml

Ir-Renju Unit

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Ir-Renju Unit |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Ir-Renju Unit

Meronem IV 1 g

1 g

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 g/30 ml

---

ANNESS VII

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT, MNEJN JINGĦATA, DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTAT MEMBRU

| Stat Membru | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Għamla farmaċewtika | Qawwa | Speċi li fuqhom għandu jintuża l-prodott | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Stat Membru

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Għamla farmaċewtika

Qawwa

Speċi li fuqhom għandu jintuża l-prodott

Mnejn jingħata

L-Awstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

Il-Belġju

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

Ċipru

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Soluzzjoni orali

Tilmikosina

250 mg/ml

Tiġieġ

Ħnieżer

Orali

Ir-Repubblika Ċeka

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC sol. ad us. vet.

Soluzzjoni orali

Tilmikosina

250 mg/ml

Tiġieġ (brojlers)

Ħnieżer

Għoġiela

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Frat (għoġiela)

Ħnieżer għas-simna

Tiġieġ

Orali

Il-Greċja

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

Spanja

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Ħnieżer

Tjur (minbarra tiġieġ li jbidu)

Dundjani

Frat

Orali

Franza

| Lilly France SA |
| --- |
| Départament Elanco Santé Animale |
| 13 Rue Pagès |
| 92158 Suresnes Cedex |
| France |

Lilly France SA

Départament Elanco Santé Animale

13 Rue Pagès

92158 Suresnes Cedex

France

PULMOTIL AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Ħnieżer

Għoġiela

Tiġieġ

Dundjani

Orali

L-Ungerija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC oral solution

Soluzzjoni orali

Tilmikosina 250 mg/ml

Frat (għoġiela)

Ħnieżer

Tiġieġ

Dundjani

Orali

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Orali

Ir-Renju Unit

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Orali

L-Italja

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italia |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italia

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

Il-Lussemburgu

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

L-Olanda

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

Il-Portugall

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Dundjani

Ħnieżer

Għoġiela

Orali

Il-Polonja

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Ħnieżer

Għoġiela

Orali

Ir-Repubblika Slovakka

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Tiġieġ

Ħnieżer

Għoġiela

Orali

Ir-Rumanija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil AC

Soluzzjoni orali

Tilmikosina 250 mg/ml

Ħnieżer

Brojlers

Għoġiela

Orali

---

ANNESS VIII

LISTA TAL-ISMIJIET, GĦAMLA FARMAĊEWTIKA, QAWWA TAL-PRODOTTI MEDIĊINALI VETERINARJI, SPEĊI LI FUQHOM GĦANDU JINTUŻA L-PRODOTT, MNEJN JINGĦATA, DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTAT MEMBRU

40 g tilmikosina kull 1 000 g

| Stat Membru | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Għamla farmaċewtika | Qawwa | Speċi li fuqhom għandu jintuża l-prodott | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| Il-Belġju | Eli Lilly Benelux N.V. |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Stat Membru

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Għamla farmaċewtika

Qawwa

Speċi li fuqhom għandu jintuża l-prodott

Mnejn jingħata

Il-Belġju

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 40 VET Premix

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 40 AMV

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 40 Granulat

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Id-Danimarka

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Spanja

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL 40

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Franza

| Lilly France SA |
| --- |
| Départament Elanco Santé Animale |
| 13 Rue Pagès |
| 92158 Suresnes Cedex |
| France |

Lilly France SA

Départament Elanco Santé Animale

13 Rue Pagès

92158 Suresnes Cedex

France

Pulmotil Tilmikosinae 40 Porcins

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G40 Premix

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Olanda

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil G40 premix

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Portugall

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

PULMOTIL G40 Pré Mistura para alimento medicamentoso

Premix għal oġġetti tal-għalf medikati

40 g tilmikosina kull 1 000 g

Ħnieżer

Orali

100 g tilmikosina kull 1 000 g

| Stat Membru | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Għamla farmaċewtika | Qawwa | L-ispeċi tal-annimali | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Stat Membru

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Għamla farmaċewtika

Qawwa

L-ispeċi tal-annimali

Mnejn jingħata

L-Awstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

PULMOTIL Prämix 10 % - Granulat für Schweine

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Belġju

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 100 VET Premix

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Belġju

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52-Bte |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52-Bte

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 100 Granules

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 100 AMV

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 100

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Id-Danimarka

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Id-Danimarka

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet Oralt pulver

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Spanja

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL 100

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G100 Premix

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Italja

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italia |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italia

PULMOTIL G100 PREMIX

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Lussemburgu

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 100 Vet Premix

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Olanda

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil G100 premix

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Portugall

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

PULMOTIL G100 Pré Mistura para alimento medicamentoso

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Ir-Renju Unit

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G100 Premix

Premix għal oġġetti tal-għalf medikati

100 g tilmikosina kull 1 000 g

Ħnieżer

Orali

200 g tilmikosina kull 1 000 g

| Stat Membru | Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq | Isem ivvintat | Għamla farmaċewtika | Qawwa | L-ispeċi tal-annimali | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Stat Membru

Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq

Isem ivvintat

Għamla farmaċewtika

Qawwa

L-ispeċi tal-annimali

Mnejn jingħata

L-Awstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

Pulmotil Prämix 20 %

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer, Fniek

Orali

Il-Belġju

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 200 VET Premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer, Fniek

Orali

Ir-Repubblika Ċeka

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

PULMOTIL 200 prm. ad us. vet.

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Ċipru

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil G200

Premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 20 % AMV

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Ġermanja

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Germany |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Germany

Pulmotil G 20 %

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Id-Danimarka

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Denmark |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Denmark

Pulmotil Vet

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Greċja

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil 200 medicated premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Spanja

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Spain |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Spain

PULMOTIL 200

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Ungerija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil G 200 premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Irlanda

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G200 Premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

L-Italja

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italia |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italia

PULMOTIL G200 PREMIX

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer, Fniek

Orali

Il-Latvja

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil 200 premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Lussemburgu

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgium |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgium

Pulmotil 200 Vet Premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer, Fniek

Orali

L-Olanda

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| The Netherlands |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

The Netherlands

Pulmotil G200 premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Polonja

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmontil 200

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Il-Portugall

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugal |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugal

PULMOTIL G200 Pré Mistura para alimento medicamentoso

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Ir-Rumanija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

Pulmotil 200 Vet Premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

Ir-Repubblika Slovakka

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Austria |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Austria

PULMOTIL G 200

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer għas-simna

Orali

Ir-Renju Unit

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| United Kingdom |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

United Kingdom

Pulmotil G200 Premix

Premix għal oġġetti tal-għalf medikati

200 g tilmikosina kull 1 000 g

Ħnieżer

Orali

---

ANNESS IX

LISTA TAL-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATAW, U D-DETENTURI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem Ivvintat Isem | Qawwa | Għamla Farmaċewtika | Mnjen jingħata |
| --- | --- | --- | --- | --- | --- |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Tabletten | 100 mg | Pillola | Użu orali |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Granulat | 100 mg | Granijiet għal suspensjoni orali | Użu orali |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Suppositorien | 100 mg | Suppositorju | Użu għal ġor-rektum |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 200 mg - Suppositorien | 200 mg | Suppositorju | Użu għal ġor-rektum |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Tabletten | 100 mg | Pillola | Użu orali |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Granulat | 100 mg | Granijiet għal suspensjoni orali | Użu orali |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Suppositirien | 100 mg | Suppositorju | Użu għal ġor-rektum |
| L-Awstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 200 mg - Suppositorien | 200 mg | Suppositorju | Użu għal ġor-rektum |
| Il-Belġju | THERABEL PHARMA S.A., |
| Rue E.Van Ophem, 108 B-1180 Uccle |

Stat Membru

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

Isem Ivvintat Isem

Qawwa

Għamla Farmaċewtika

Mnjen jingħata

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Tabletten

100 mg

Pillola

Użu orali

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Granulat

100 mg

Granijiet għal suspensjoni orali

Użu orali

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Suppositorien

100 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 200 mg - Suppositorien

200 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Tabletten

100 mg

Pillola

Użu orali

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Granulat

100 mg

Granijiet għal suspensjoni orali

Użu orali

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Suppositirien

100 mg

Suppositorju

Użu għal ġor-rektum

L-Awstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 200 mg - Suppositorien

200 mg

Suppositorju

Użu għal ġor-rektum

Il-Belġju

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

AULIN 100 mg

100 mg

Pillola

Użu orali

Il-Belġju

| THERABEL PHARMA S.A., |
| --- |
| Rue E.Van Ophem, 108 B-1180 Uccle |

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

AULIN 100 mg

100 mg

Granijiet għal suspensjoni orali

Użu orali

Il-Belġju

| THERABEL PHARMA S.A., |
| --- |
| Rue E.Van Ophem, 108 B-1180 Uccle |

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

MESULID

100 mg

Granijiet għal suspensjoni orali

Użu orali

Il-Belġju

| THERABEL PHARMA S.A., |
| --- |
| Rue E.Van Ophem, 108 B-1180 Uccle |

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

MESULID 100 mg

100 mg

Pillola

Użu orali

Il-Bulgarija

Tchaika Pharma Sofia 1172 1, G. M. Dimitrov Blvd.

AllGone

100 mg

Pillola li tfexfex

Użu orali

Il-Bulgarija

Sopharma Sofia 1220 16, Iliensko shosse

Ameolin

100 mg

Pillola

Użu orali

Il-Bulgarija

CSC Pharmaceuticals Sofia 1592 10, Assen Jordanov street

100 mg

Pillola

Użu orali

Il-Bulgarija

CSC Pharmaceuticals Sofia 1592 10, Assen Jordanov street

Aulin 100

100 mg

Granijiet

Użu orali

Il-Bulgarija

Inbioteh Sofia 1000 5, Triaditza street ‘Sofia palace’

Biolin

100 mg

Pillola

Użu orali

Il-Bulgarija

ZentivaSofia 1407 25, N.Vaptzarov Blvd.

Coxtral

100 mg

Pillola

Użu orali

Il-Bulgarija

Actavis Sofia 1000 2, Kniaginia Maria Luisa Blvd.

Enetra

100 mg

Pillola

Użu orali

Il-Bulgarija

Medochemie Sofia 1113 20, Fr. Jolio Currie street

Aponil

100 mg

Pillola

Użu orali

Il-Bulgarija

CSC Pharmaceuticals Sofia 1592 10, Assen Jordanov street

Nimed

100 mg

Pillola

Użu orali

Il-Bulgarija

LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, L-Italja

Nimesil

100 mg

Granijiet

Użu orali

CZ - Ir-Repubblika Ċeka

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Ir-Repubblika Ċeka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Ir-Repubblika Ċeka

AULIN

100 mg

Granijiet għal soluzzjoni orali

Użu orali

CZ - Ir-Repubblika Ċeka

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Ir-Repubblika Ċeka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Ir-Repubblika Ċeka

AULIN

100 mg

Pillola

Użu orali

CZ - Ir-Repubblika Ċeka

| ZENTIVA, a.s. |
| --- |
| Empiria Palace |
| Na strži 63 |
| 140 62 Praha 4, Ir-Repubblika Ċeka |

ZENTIVA, a.s.

Empiria Palace

Na strži 63

140 62 Praha 4, Ir-Repubblika Ċeka

COXTRAL 100 mg TABLETY

100 mg

Pillola

Użu orali

CZ - Ir-Repubblika Ċeka

CSC Pharmaceuticals Handels GmbH Gewerbestrasse 18-20 A-2102 Bisamberg, L-Awstrija

MESULID

100 mg

Granijiet għal soluzzjoni orali

Użu orali

CZ - Ir-Repubblika Ċeka

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Ir-Repubblika Ċeka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Ir-Repubblika Ċeka

NIMED

100 mg

Pillola

Użu orali

CZ - Ir-Repubblika Ċeka

| LABORATORI GUIDOTTI S.p.A., Via Livornese 897, |
| --- |
| I - 56010 La Vettola, PISA, L-Italja |

LABORATORI GUIDOTTI S.p.A., Via Livornese 897,

I - 56010 La Vettola, PISA, L-Italja

NIMESIL

100 mg

Granijiet għal suspensjoni orali

Użu orali

Ċipru

MEDOCHEMIE LTD, POBOX 51409, 3505 LEMESOS, ĊIPRU

APONIL

100 mg

PILLOLA

UŻU ORALI

Ċipru

CDL PHARMACEUTICAL LTD, POBOX 40981, 6308 LARNACA, ĊIPRU

ELINAP

100 mg

PILLOLA

UŻU ORALI

Ċipru

CHR. K. UNIMED LTD, 21 DAVLOU, PLATI, 2114 AGLANTZIA, LEFKOSIA, ĊIPRU

FLOGOSTOP

100 mg

PILLOLA

UŻU ORALI

Ċipru

P T HADJIGEORGIOU CO LTD, POBOX 53158, 3301 LEMESOS, ĊIPRU

NIMELIDE

100 mg

PILLOLA

UŻU ORALI

Ċipru

CODAL SYNTO LTD, POBOX 51785, 3508 LEMESOS, ĊIPRU

NIMM

100 mg

PILLOLA

UŻU ORALI

Ċipru

THE STAR MEDICINES IMPORTERS & CO LTD, POBOX 50151, 3601 LEMESOS, ĊIPRU

RITAMINE

100 mg

PILLOLA

UŻU ORALI

Ċipru

COSMED HOLDINGS LTD, P.O.BOX 42145, 6531 LARNACA, ĊIPRU

SPECILID

100 mg

PILLOLA

UŻU ORALI

L-Estonja

| Zentiva a.s. U Kabelovny 130 |
| --- |
| Dolni Mecholupy |
| 102 37 Praque 10 |

Zentiva a.s. U Kabelovny 130

Dolni Mecholupy

102 37 Praque 10

COXTRAL

100 mg

Pillola

Użu orali

Franza

| THERABEL LUCIEN PHARMA |
| --- |
| 123 rue Jules Guesde |
| 92309 LEVALLOIS-PERRET Cedex |
| Franza |

THERABEL LUCIEN PHARMA

123 rue Jules Guesde

92309 LEVALLOIS-PERRET Cedex

Franza

NEXEN

100 mg

Pillola

Użu orali

Franza

| THERABEL LUCIEN PHARMA |
| --- |
| 123 rue Jules Guesde |
| 92309 LEVALLOIS-PERRET Cedex |
| Franza |

THERABEL LUCIEN PHARMA

123 rue Jules Guesde

92309 LEVALLOIS-PERRET Cedex

Franza

NEXEN

100 mg

Granijiet għal soluzzjoni orali

Użu orali

Franza

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| DUBLIN 15 |
| L-IRLANDA |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

DUBLIN 15

L-IRLANDA

OXETIAN

100 mg

Pillola

Użu orali

Franza

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| DUBLIN 15 |
| L-IRLANDA |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

DUBLIN 15

L-IRLANDA

OXETIAN

100 mg

Granijiet għal soluzzjoni orali

Użu orali

Il-Greċja

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| 5TH Km PAEANIAS-MARKOPOULO AVENUE |
| KOROPI, ATTIKIS, 19400 |

BOEHRINGER INGELHEIM HELLAS S.A.

5TH Km PAEANIAS-MARKOPOULO AVENUE

KOROPI, ATTIKIS, 19400

MESULID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| 5TH Km PAEANIAS-MARKOPOULO AVENUE |
| KOROPI, ATTIKIS, 19400 |

BOEHRINGER INGELHEIM HELLAS S.A.

5TH Km PAEANIAS-MARKOPOULO AVENUE

KOROPI, ATTIKIS, 19400

MESULID

200 mg

SUPPOSITORJU

UŻU GĦAL ĠOR-REKTUM

Il-Greċja

| BOEHRINGER INGELHEIM HELLAS S.A. |
| --- |
| 5TH Km PAEANIAS-MARKOPOULO AVENUE |
| KOROPI, ATTIKIS, 19400 |

BOEHRINGER INGELHEIM HELLAS S.A.

5TH Km PAEANIAS-MARKOPOULO AVENUE

KOROPI, ATTIKIS, 19400

MESULID

100 mg

GRANIJIET GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| FARMEDIA A.E. |
| --- |
| ATHINAS 22 & APOLLONOS |
| GERAKAS, ATTIKIS, 15344 |

FARMEDIA A.E.

ATHINAS 22 & APOLLONOS

GERAKAS, ATTIKIS, 15344

MULTIFORMIL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| PHARMATHEN INTERNATIONAL S.A. IL-GREĊJA , |
| --- |
| DERVENAKIWN 4, PALLINI, ATTIKIS 15351 |

PHARMATHEN INTERNATIONAL S.A. IL-GREĊJA ,

DERVENAKIWN 4, PALLINI, ATTIKIS 15351

BIOXIDOL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| ALET PHARMACEUTIC |
| --- |
| ALS M. ALEXANDER 121, AGIA VARVARA, 12351 |

ALET PHARMACEUTIC

ALS M. ALEXANDER 121, AGIA VARVARA, 12351

SPECILID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| BIOSPRAY ABEE |
| --- |
| 18TH Km MARATHONOS AVENUE, PALLINI, 15344 |

BIOSPRAY ABEE

18TH Km MARATHONOS AVENUE, PALLINI, 15344

FLOGOSTOP

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| BIOMEDICA-CHEMICA A.E. |
| --- |
| G. LYRA 25, KATW KIFISSIA |

BIOMEDICA-CHEMICA A.E.

G. LYRA 25, KATW KIFISSIA

NIMESULIDE/BIOMEDICA CHEMICA

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, ARGYROUPOLI, 16452 |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22, ARGYROUPOLI, 16452

RISTOLZIT

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| NORMA HELLAS A.E. |
| --- |
| MENANDROU 54, ATHENS, 10431 |

NORMA HELLAS A.E.

MENANDROU 54, ATHENS, 10431

MYXINA

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| GENEPHARM A.E. |
| --- |
| 18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351 |

GENEPHARM A.E.

18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351

NIMELIDE

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| BROS EPE |
| --- |
| AVGIS & GALLINIS 15, N. KIFISSIA |

BROS EPE

AVGIS & GALLINIS 15, N. KIFISSIA

DISCORID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| RAFARM AEBE |
| --- |
| KORINTHOU 12, N. PSYCHIKO, 15451 |

RAFARM AEBE

KORINTHOU 12, N. PSYCHIKO, 15451

VENTOR

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| RAFARM AEBE |
| --- |
| KORINTHOU 12, N. PSYCHIKO, 15451 |

RAFARM AEBE

KORINTHOU 12, N. PSYCHIKO, 15451

VENTOR

100 mg

GRANIJIET GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| ARMEDICA A.E. |
| --- |
| AGIAS MARKELLIS 17, ATHENS, 11855 |

ARMEDICA A.E.

AGIAS MARKELLIS 17, ATHENS, 11855

ALENCAST

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| GAP A.E. |
| --- |
| AGISILAOU 46, AGIOS DIMITRIOS, 17341 |

GAP A.E.

AGISILAOU 46, AGIOS DIMITRIOS, 17341

G-REVM

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| VIOFAR EPE |
| --- |
| ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671 |

VIOFAR EPE

ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671

VOLONTEN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| KLEVA EPE |
| --- |
| PARNITHOS AVENUE 189, |
| AHARNAI, ATTIKIS, 13671 |

KLEVA EPE

PARNITHOS AVENUE 189,

AHARNAI, ATTIKIS, 13671

ELINAP

100 mg

TRAB GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| KLEVA EPE |
| --- |
| PARNITHOS AVENUE 189, |
| AHARNAI, ATTIKIS, 13671 |

KLEVA EPE

PARNITHOS AVENUE 189,

AHARNAI, ATTIKIS, 13671

ELINAP

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| MINERVA PHARMAKEFTIKI A.E. |
| --- |
| KIFISSOU AVENUE 132, PERISTERI, 12131 |

MINERVA PHARMAKEFTIKI A.E.

KIFISSOU AVENUE 132, PERISTERI, 12131

MIN-A-PON

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| ANFARM HELLAS A.E. |
| --- |
| K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232 |

ANFARM HELLAS A.E.

K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232

LEMESIL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| MARATHONOS AVENUE 95, PIKERMI, 19009 |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

MARATHONOS AVENUE 95, PIKERMI, 19009

ROLAKET

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| MARATHONOS AVENUE 95, PIKERMI, 19009 |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

MARATHONOS AVENUE 95, PIKERMI, 19009

ROLAKET

200 mg

SUPPOSITORJU

UŻU GĦAL ĠOR-REKTUM

Il-Greċja

| ANTOR EPE |
| --- |
| P. MAVROMIHALI 1, VRILISSIA, 15235 |

ANTOR EPE

P. MAVROMIHALI 1, VRILISSIA, 15235

MELIMONT

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| HELP ABEE |
| --- |
| VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452 |

HELP ABEE

VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452

MOSUOLIT

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, GERAKAS, 15344 |

FINIXFARM EPE

DERVENAKION 38 & SAHINI, GERAKAS, 15344

KARTAL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS |
| --- |
| DILOU 9, PERISTERI, ATTIKIS, 12134 |

PHARMACEUTICAL INDUSTRY PROEL EPAM. G. KORONIS

DILOU 9, PERISTERI, ATTIKIS, 12134

FLADALGIN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| REMEK PHARMACEUTICALS ABEE |
| --- |
| PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564 |

REMEK PHARMACEUTICALS ABEE

PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564

MESUPON

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| FARMANIC CHEMIPHARMA S.A. |
| --- |
| FYLIS 137, KAMATERO, ATTIKIS, 13451 |

FARMANIC CHEMIPHARMA S.A.

FYLIS 137, KAMATERO, ATTIKIS, 13451

CHEMISULIDE

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| REMEDINA ABEE |
| --- |
| GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451 |

REMEDINA ABEE

GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451

AMOCETIN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| COSMOPHARM EPE |
| --- |
| P.O. BOX 42, KORINTHOS, 20100 |

COSMOPHARM EPE

P.O. BOX 42, KORINTHOS, 20100

LIZEPAT

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| DEMO ABEE |
| --- |
| 21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565 |

DEMO ABEE

21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565

RITAMINE

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| BALU EPE |
| --- |
| 30 Km ATHENS-LAVRION, MARKOPOULO |

BALU EPE

30 Km ATHENS-LAVRION, MARKOPOULO

NIBERAN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| SANDOZ GMBH, KUNDL, L-AWSTRIJA |
| --- |
| BIOCHEMIESTRASSE 10, A-6250, KUNDL L-AWSTRIJA |

SANDOZ GMBH, KUNDL, L-AWSTRIJA

BIOCHEMIESTRASSE 10, A-6250, KUNDL L-AWSTRIJA

NIMESULIDE / HEXAL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| SANDOZ GMBH, KUNDL, L-AWSTRIJA |
| --- |
| BIOCHEMIESTRASSE 10, A-6250, KUNDL L-AWSTRIJA |

SANDOZ GMBH, KUNDL, L-AWSTRIJA

BIOCHEMIESTRASSE 10, A-6250, KUNDL L-AWSTRIJA

NIMESULIDE / HEXAL

100 mg

TRAB GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| VELKA HELLAS AEBE |
| --- |
| KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451 |

VELKA HELLAS AEBE

KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451

NAOFID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| DOCTUM A.E. K.T. GIOKARIS & SIA |
| --- |
| 1 Km PAEANIAS-MARKOPOULOU AVENUE, PAEANIA, ATTIKIS, 19002 |

DOCTUM A.E. K.T. GIOKARIS & SIA

1 Km PAEANIAS-MARKOPOULOU AVENUE, PAEANIA, ATTIKIS, 19002

ERLECIT

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, GLYFADA, 16674 |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150, GLYFADA, 16674

TRANZICALM

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| MEDICHROM A.E. |
| --- |
| 6 Km MARKOPOULOU-KOROPI AVENUE, MARKOPOULO, MESOGEION, 19003 |

MEDICHROM A.E.

6 Km MARKOPOULOU-KOROPI AVENUE, MARKOPOULO, MESOGEION, 19003

NIMESUL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| FARAN ABEE |
| --- |
| PRODUCTION AND TRADING MEDICINES |
| AVEROF 19A, ATHENS, 10433 |

FARAN ABEE

PRODUCTION AND TRADING MEDICINES

AVEROF 19A, ATHENS, 10433

AFLOGEN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

100 mg

GRANIJIET GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

200 mg

SUPPOSITORJU

UŻU GĦAL ĠOR-REKTUM

Il-Greċja

| S.J.A. PHARM O.E. |
| --- |
| ARKOLEON 11, KATO PATISSIA, 10445 |

S.J.A. PHARM O.E.

ARKOLEON 11, KATO PATISSIA, 10445

CLIOVYL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| COUP ABEE |
| --- |
| AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235 |

COUP ABEE

AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235

MELICAT

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| PHARMACYPRIA HELLAS A.E. |
| --- |
| PASTER 6, AMPELOKIPOI, 11521 |

PHARMACYPRIA HELLAS A.E.

PASTER 6, AMPELOKIPOI, 11521

LALIDE

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| PHARMACYPRIA HELLAS A.E. |
| --- |
| PASTER 6, AMPELOKIPOI, 11521 |

PHARMACYPRIA HELLAS A.E.

PASTER 6, AMPELOKIPOI, 11521

LALIDE

50 mg /5 ml

SUSPENSJONI ORALI

UŻU ORALI

Il-Greċja

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

Pillola li tfexfex

UŻU ORALI

Il-Greċja

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

GRANIJIET GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

200 mg

SUPPOSITORJU

UŻU GĦAL ĠOR-REKTUM

Il-Greċja

| EVAGGELOS KALOFOLIAS & SIA O.E. |
| --- |
| MENANDROU 54, ATHENS, 10431 |

EVAGGELOS KALOFOLIAS & SIA O.E.

MENANDROU 54, ATHENS, 10431

ALGOVER

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| FARMILIA E.E. |
| --- |
| FAVIEROU 48, ATHENS |

FARMILIA E.E.

FAVIEROU 48, ATHENS

AUROMELID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| AURORA PHARMACEUTICALS EPE |
| --- |
| EVROU & MESSINIAS, GERAKAS, 15344 |

AURORA PHARMACEUTICALS EPE

EVROU & MESSINIAS, GERAKAS, 15344

SUDINET

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| LEOVAN M. LEON & SIA E.E. |
| --- |
| ARGONAFTON 22, ARGYROUPOLI, 16452 |

LEOVAN M. LEON & SIA E.E.

ARGONAFTON 22, ARGYROUPOLI, 16452

LASAZIN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| PHARMACHEM EPE |
| --- |
| YMITOU 73, VRILISSIA, ATTIKIS, 15235 |

PHARMACHEM EPE

YMITOU 73, VRILISSIA, ATTIKIS, 15235

NIMESULIDE / PHARMACHEM

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| ANTONIOS POLYCHRONIS OF MARINOU |
| --- |
| IONIAS 29, NEO PSYCHIKO, 15451 |

ANTONIOS POLYCHRONIS OF MARINOU

IONIAS 29, NEO PSYCHIKO, 15451

OMNIBUS

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| ZWITTER PHARMACEUTICALS EPE, IL-GREĊJA |
| --- |
| PENTELIS AVENUE 34-36, ATHENS, 15234 |

ZWITTER PHARMACEUTICALS EPE, IL-GREĊJA

PENTELIS AVENUE 34-36, ATHENS, 15234

RHEMID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| MED-ONE S.A., HELLAS |
| --- |
| PARNITHOS AVENUE 211, AHARNAI, 13671 |

MED-ONE S.A., HELLAS

PARNITHOS AVENUE 211, AHARNAI, 13671

ALGOSULID

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| MED-ONE S.A., HELLAS |
| --- |
| PARNITHOS AVENUE 211, AHARNAI, 13671 |

MED-ONE S.A., HELLAS

PARNITHOS AVENUE 211, AHARNAI, 13671

ALGOSULID

100 mg

TRAB GĦAL SOLUZZJONI ORALI

UŻU ORALI

Il-Greċja

| LAMDA PHARMAKEFTIKI A.E. |
| --- |
| EVRIPIDOU 18, ATHENS, 10559 |

LAMDA PHARMAKEFTIKI A.E.

EVRIPIDOU 18, ATHENS, 10559

NIMESORAL

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| MEDARTE FARMAKEFTIKI ABEE |
| --- |
| SPYROU VRETTOU 10, METAMORFOSI, 14452 |

MEDARTE FARMAKEFTIKI ABEE

SPYROU VRETTOU 10, METAMORFOSI, 14452

NIMESULIDE / MEDICON

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| FARMAMUST EPE |
| --- |
| PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443 |

FARMAMUST EPE

PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443

LOVIREM

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| B.I. FARMA A.E. |
| --- |
| ARISTOTELOUS 79-81, ATHENS, 10434 |

B.I. FARMA A.E.

ARISTOTELOUS 79-81, ATHENS, 10434

NIMESULIDE / B.I. FARMA

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

100 mg

PILLOLA

UŻU ORALI

Il-Greċja

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

200 mg

SUPPOSITORJU

UŻU GĦAL ĠOR-REKTUM

Il-Greċja

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

100 mg

GRANIJIET GĦAL SOLUZZJONI ORALI

UŻU ORALI

L-Ungerija

Chinoin Zrt.1045 Budapest, Tó u.1-5.

Winsulid

100 mg

Granijiet

Użu orali

L-Ungerija

Chinoin Zrt.1045 Budapest, Tó u.1-5.

Winsulid

100 mg

Pillola

Użu orali

L-Ungerija

Sanofi-Aventis 1045 Budapest, Tó u.1-5

Mesulid

100 mg

Granijiet

Użu orali

L-Ungerija

Sanofi-Aventis 1045 Budapest, Tó u.1-5

Mesulid

100 mg

Pillola

Użu orali

L-Ungerija

PannonPharma Gyógyszergyártó Kft. 1016 Budapest Derék u.2.

Nimelid

100 mg

Pillola

Użu orali

L-Ungerija

Eurodrug Lab.BV 4032 Debrecen,Bartha Boldizsár u.7.

Nidol

100 mg

Pillola

Użu orali

L-Ungerija

LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, L-Italja

Xilox

100 mg

Granijiet

Użu orali

L-Irlanda

Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 L-Irlanda

Aulin

100 mg

Pillola

Użu orali

L-Irlanda

Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 L-Irlanda

Aulin

100 mg

Granijiet

Użu orali

L-Irlanda

Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 L-Irlanda

Mesulid

100 mg

Pillola

Użu orali

L-Irlanda

Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 L-Irlanda

Mesulid

100 mg

Granijiet

Użu orali

L-Irlanda

Pinewood Laboratories Ltd Ballymacarbry Clonmel Co. Tipperary L-Irlanda

Mesine

100 mg

Pillola

Użu orali

L-Irlanda

PCO Manufacturing Ltd. Unit 222 Western Industrial Estate, Naas Road, Dublin 12 L-Irlanda

Aulin

100 mg

Pillola

Użu orali

L-Irlanda

B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, Ir-Renju Unit

Aulin

100 mg

Granijiet

Użu orali

L-Irlanda

B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, Ir-Renju Unit

Aulin

100 mg

Pillola

Użu orali

L-Italja

FRANCIA FARMAC.IND.FAR.BIO.Srl Via DEI PESTAGALLI, 7 20138 MILANO

ALGIMESIL

100 mg

Granijiet

Użu orali

L-Italja

FRANCIA FARMAC.IND.FAR.BIO.Srl Via DEI PESTAGALLI, 7 20138 MILANO

ALGIMESIL

100 mg

Pillola

Użu orali

L-Italja

SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO

ALGOLIDER

100 mg

Granijiet

Użu orali

L-Italja

SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO

ALGOLIDER

100 mg

Pillola

Użu orali

L-Italja

SELVI LABORAT.BIOTERAPICO SpA, VIA PROCOIO, 28, 00065 FIANO ROMANO

ANTALGO

100 mg

Granijiet

Użu orali

L-Italja

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

100 mg

Granijiet

Użu orali

L-Italja

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

100 mg

Pillola

Użu orali

L-Italja

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

100 mg

Granijiet

Użu orali

L-Italja

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

100 mg

Pillola

Użu orali

L-Italja

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN BETA

400 mg

Granijiet

Użu orali

L-Italja

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN BETA

400 mg

Pillola

Użu orali

L-Italja

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN MITE

50 mg

Granijiet

Użu orali

L-Italja

AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO

DELFOS

100 mg

Granijiet

Użu orali

L-Italja

AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO

DELFOS

100 mg

Pillola

Użu orali

L-Italja

SARDA PHARMACEUTICA Srl, VIA CASTIGLIONE 92/B 09100 CAGLIARI

DIMESUL

100 mg

Granijiet

Użu orali

L-Italja

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Granijiet

Użu orali

L-Italja

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Pillola

Użu orali

L-Italja

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Italja

SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO

EDEMAX

100 mg

Granijiet

Użu orali

L-Italja

SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO

EDEMAX

100 mg

Pillola

Użu orali

L-Italja

AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA

EFRIDOL

100 mg

Granijiet

Użu orali

L-Italja

AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA

EFRIDOL

100 mg

Pillola

Użu orali

L-Italja

I.B.N. SAVIO Srl, VIA E.BAZZANO, 14, 16019 RONCO SCRIVIA

EUDOLENE

100 mg

Granijiet

Użu orali

L-Italja

NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA

FANSIDOL

100 mg

Granijiet

Użu orali

L-Italja

NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA

FANSIDOL

100 mg

Kapsula

Użu orali

L-Italja

SOFAR SpA, VIA ISONZO, 8, 20100 MILANO

FANSULIDE

100 mg

Granijiet

Użu orali

L-Italja

SOFAR SpA, VIA ISONZO, 8, 20100 MILANO

FANSULIDE

100 mg

Pillola

Użu orali

L-Italja

PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO

FLAMINIDE

100 mg

Granijiet

Użu orali

L-Italja

PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO

FLAMINIDE

100 mg

Pillola

Użu orali

L-Italja

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Granijiet

Użu orali

L-Italja

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Pillola

Użu orali

L-Italja

ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA

IDEALID

100 mg

Pillola

Użu orali

L-Italja

MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA

ISODOL

100 mg

Granijiet

Użu orali

L-Italja

MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA

ISODOL

100 mg

Pillola

Użu orali

L-Italja

BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO

LEDOREN

100 mg

Granijiet

Użu orali

L-Italja

BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO

LEDOREN

100 mg

Pillola

Użu orali

L-Italja

ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA

LIDERSOLV

100 mg

Granijiet

Użu orali

L-Italja

ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA

LIDERSOLV

100 mg

Pillola

Użu orali

L-Italja

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

100 mg

Granijiet

Użu orali

L-Italja

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

100 mg

Pillola

Użu orali

L-Italja

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID FAST

400 mg

Granijiet

Użu orali

L-Italja

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID MITE

50 mg

Granijiet

Użu orali

L-Italja

NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA

NERELID

100 mg

Granijiet

Użu orali

L-Italja

NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA

NERELID

100 mg

Kapsula

Użu orali

L-Italja

I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA

NIDE

100 mg

Granijiet

Użu orali

L-Italja

I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA

NIDE

100 mg

Kapsula

Użu orali

L-Italja

MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI

NIDEMOL

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI

NIDEMOL

100 mg

Granijiet

Użu orali

L-Italja

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Granijiet

Użu orali

L-Italja

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Pillola

Użu orali

L-Italja

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Granijiet

Użu orali

L-Italja

KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO

NIMENOL

100 mg

Granijiet

Użu orali

L-Italja

KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO

NIMENOL

100 mg

Granijiet

Użu orali

L-Italja

LAB.GUIDOTTI SpA, VIA LIVORNESE, 897, 56010 LA VETTOLA - PISA

NIMESULENE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

LAB.GUIDOTTI SpA, VIA LIVORNESE, 897, 56010 LA VETTOLA - PISA

NIMESULENE

100 mg

Granijiet

Użu orali

L-Italja

LAB.GUIDOTTI SpA, VIA LIVORNESE, 897, 56010 LA VETTOLA - PISA

NIMESULENE

100 mg

Pillola

Użu orali

L-Italja

ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA

NIMESULIDE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, CINISELLO BALSAMO

NIMESULIDE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Pillola li tomgħodha

Użu orali

L-Italja

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

POLIFARMA SpA, VIALE DELL'ARTE, 69, 00144 ROMA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

JET GENERICI Srl, VIA MARIO LALLI, 8, 56127 PISA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA

NIMESULIDE

100 mg

Granijiet

Użu orali

L-Italja

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Pillola

L-Italja

RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Pillola

Użu orali

L-Italja

SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO

NIMESULIDE

100 mg

Kapsula

Użu orali

L-Italja

FARMAC.CABER SpA, VIALE CITTA' D'EUROPA, 681, ROMA

NIMS

100 mg

Granijiet

Użu orali

L-Italja

LEVOFARMA Srl, VIA CONFORTI, 42, 84083 CASTEL SAN GIORGIO

NOALGOS

100 mg

Granijiet

Użu orali

L-Italja

LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO

NOXALIDE

100 mg

Granijiet

Użu orali

L-Italja

LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO

NOXALIDE

60 ml 5 %

Qtar orali

Użu orali

L-Italja

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

ORONIME

100 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Italja

PANTAFARM Srl, VIA PALESTRO, 14, 00185 ROMA

PANTAMES

100 mg

Pillola li tinħall fil-ħalq

Użu orali

L-Italja

VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA

REMOV

100 mg

Granijiet

Użu orali

L-Italja

VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA

REMOV

100 mg

Pillola

Użu orali

L-Italja

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

100 mg

Granijiet

Użu orali

L-Italja

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

100 mg

Pillola

Użu orali

L-Italja

NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

REUMALIDE

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

REUMALIDE

100 mg

Granijiet

Użu orali

L-Italja

MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO

SOLVING

100 mg

Granijiet

Użu orali

L-Italja

MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO

SOLVING

100 mg

Pillola

Użu orali

L-Italja

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Granijiet

Użu orali

L-Italja

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Pillola

Użu orali

L-Italja

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Granijiet

Użu orali

L-Italja

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Pillola

Użu orali

L-Italja

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

SULIDE

100 mg

Granijiet

Użu orali

L-Italja

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

SULIDE

100 mg

Pillola

Użu orali

L-Italja

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

200 mg

Suppositorju

Użu għal ġor-rektum

L-Italja

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

100 mg

Granijiet

Użu orali

L-Italja

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

100 mg

Pillola

Użu orali

Il-Latvja

Helsinn Birex Pharmaceutical Ltd., Damastown, Mulhurddart, Dublin 15, L-Irlanda

Mesulid

100 mg

Pillola

Użu orali

Il-Latvja

Laboratori Guidotti S. P. A., Via Trieste 40, I-56126 Pisza, L-Italja

Nimesil

100 mg

Granijiet għal suspensjoni orali

Użu orali

Il-Latvja

Medochemie Ltd., P. O. Box 51409, CY-3505 Limassol, Ċipru

Aponil

100 mg

Pillola

Użu orali

Il-Latvja

Zentiva a. S., Nitrianska 100, 92027 Hlohovec, Is-Slovakkja

Coxtral

100 mg

Pillola

Użu orali

Il-Litwanja

Medochemie Ltd., P. O. Box 51409 CY-3505 Limassol, Ċipru

Aponil

100 mg

Pillola

Użu orali

Il-Litwanja

Zentiva a. s., U kabelovny 130102 37 Praha 10 Dolni Mecholupy, Ir-Repubblika Ċeka

Coxtral

100 mg

Pillola

Użu orali

Il-Litwanja

Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart Dublin 15, L-Irlanda

Mesulid

100 mg

Pillola

Użu orali

Il-Litwanja

Laboratori Guidotti S.p.A., Via Livornese, 897-56010 Pisa-La Viettola, L-Italja

Nimesil

100 mg

Granijiet għal suspensjoni orali

Użu orali

Malta

Vecchi & C Piam S A, Via Padre G Semeria, 5, Genoa 16131, L-Italja

Remov

100 mg

Pillola

Użu orali

Il-Polonja

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Ir-Repubblika Ċeka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Ir-Repubblika Ċeka

AULIN

100 mg

Pillola

Użu orali

Il-Polonja

MEDICOM INTERNATIONAL S.R.O., Páteřní 7635 00 Brno, Ir-Repubblika Ċeka

AULIN

100 mg

Granijiet għal soluzzjoni orali

Użu orali

Il-Polonja

Laboratori Guidotti S. P. A., Via Livornese 897, La Vettola, 56010 Pisa, L-Italja

NIMESIL

100 mg

Granijiet għal suspensjoni orali

Użu orali

Il-Polonja

Zentiva a.s. U Kabelovny 130 Dolni Mecholupy 102 37 Praque 10

COXTRAL

100 mg

Pillola

Użu orali

Il-Portugall

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada - Dafundo |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada - Dafundo

Aulin

100 mg

Pillola

Użu orali

Il-Portugall

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada - Dafundo |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada - Dafundo

Aulin

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Angelini Farmacêutica, Lda. |
| --- |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada - Dafundo |

Angelini Farmacêutica, Lda.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada - Dafundo

Aulin

200 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Rega Farma - Promoção de |
| --- |
| Produtos Farmacêuticos, S.A. |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |

Rega Farma - Promoção de

Produtos Farmacêuticos, S.A.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Donulide

100 mg

Pillola

Użu orali

Il-Portugall

| Rega Farma - Promoção de |
| --- |
| Produtos Farmacêuticos, S.A. |
| Rua João Chagas, 53 - 3o |
| 1495-764 Cruz Quebrada |

Rega Farma - Promoção de

Produtos Farmacêuticos, S.A.

Rua João Chagas, 53 - 3o

1495-764 Cruz Quebrada

Donulide

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Labesfal - Laboratórios Almiro, |
| --- |
| S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios Almiro,

S.A. 3465-051 Campo de Besteiros

Nimalge

200 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Vida - Produtos Farmacêuticos, |
| --- |
| S.A. Vala do Carregado 2600-726 Castanheira do Ribatejo |

Vida - Produtos Farmacêuticos,

S.A. Vala do Carregado 2600-726 Castanheira do Ribatejo

Nimartin

100 mg

Pillola miksija

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos |
| --- |
| Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo |

Sanofi-Aventis - Produtos

Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo

Nimed

100 mg

Pillola miksija

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos |
| --- |
| Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo |

Sanofi-Aventis - Produtos

Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo

Nimed

100 mg

Trab għal soluzzjoni orali

Użu orali

Il-Portugall

| Sanofi-Aventis - Produtos |
| --- |
| Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo |

Sanofi-Aventis - Produtos

Farmacêuticos, S.A. Empreendimento Lagoas Park - Edifício 7 - 3o 2740-244 Porto Salvo

Nimed

200 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

Laboratori Guidotti, S.p.A. Via Trieste, 40 I-56126 Pisa

Nimesulene

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Alter, S.A. Estrada Marco do |
| --- |
| Grilo - Zemouto 2830 Coina |

Alter, S.A. Estrada Marco do

Grilo - Zemouto 2830 Coina

Nimesulida Alter 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Arrowblue Produtos Farmacêuticos |
| --- |
| S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa |

Arrowblue Produtos Farmacêuticos

S.A. Av. D. João II, 10 Esqo - Torre Fernão de Magalhães 1998-025 Lisboa

Nimesulida Arrowblue

100 mg

Pillola

Użu orali

Il-Portugall

| Farmoquímica Baldacci, S.A. |
| --- |
| Rua Duarte Galvão, 44 1549-005 Lisboa |

Farmoquímica Baldacci, S.A.

Rua Duarte Galvão, 44 1549-005 Lisboa

Nimesulida Baldacci 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Bluepharma - Indústria Farmacêutica, |
| --- |
| S.A. São Martinho do Bispo 3045-016 Coimbra |

Bluepharma - Indústria Farmacêutica,

S.A. São Martinho do Bispo 3045-016 Coimbra

Nimesulida Bluepharma 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Rua Alfredo da Silva, 16 2610-016 Amadora |

Ciclum Farma Unipessoal, Lda.

Rua Alfredo da Silva, 16 2610-016 Amadora

Nimesulida Ciclum 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

Edol Themaxis - Produtos Farmacêuticos S.A. Avenida 25 de Abril, no 6 - 6A 2795-195 Linda-a-Velha

Nimesulida Edol

100 mg

Pillola

Użu orali

Il-Portugall

| Farmoz - Sociedade Técnico- |
| --- |
| Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho |

Farmoz - Sociedade Técnico-

Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho

Nimesulida Farmoz 100 mg Comprimidos

100 mg

Pillola miksija

Użu orali

Il-Portugall

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra

Nimesulida Generis 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Generis Farmacêutica, S.A. |
| --- |
| Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra |

Generis Farmacêutica, S.A.

Office Park da Beloura - Edifício 4 - Quinta da Beloura 2710-444 Sintra

Nimesulida Generis 100 mg Granulado para Solução Oral

100 mg

Trab għal soluzzjoni orali

Użu orali

Il-Portugall

Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche

Nimesulida Gerilide 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche

Nimesulida Gerilide 100 mg Granulado para Solução Oral

100 mg

Trab għal soluzzjoni orali

Użu orali

Il-Portugall

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide

Nimesulida Germed 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Germed Farmacêutica, Lda. |
| --- |
| Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide |

Germed Farmacêutica, Lda.

Rua Alto do Montijo, 13 - 1o Dto - Edifício Monsanto 2790-012 Portela de Carnaxide

Nimesulida Germed 100 mg Granulado para suspensão oral

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| gp - genéricos portugueses, Lda. |
| --- |
| Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora |

gp - genéricos portugueses, Lda.

Rua Henrique Paiva Couceiro, 29 - Venda Nova 2700-451 Amadora

Nimesulida gp 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra

Nimesulida Inibsa 100 mg comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Laboratórios Inibsa, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra |

Laboratórios Inibsa, S.A.

Zona Industrial da Abrunheira - Edifício 1 - 2o I - Sintra Business Park 2710-089 Sintra

Nimesulida Inibsa 100 mg granulado para suspensão oral

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Tecnimede - Sociedade Técnico- |
| --- |
| Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho |

Tecnimede - Sociedade Técnico-

Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho

Nimesulida Isartrox 100 mg Comprimidos

100 mg

Pillola miksija

Użu orali

Il-Portugall

| Jaba Farmacêutica, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra |

Jaba Farmacêutica, S.A.

Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra

Nimesulida Jabasulide 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Jaba Farmacêutica, S.A. |
| --- |
| Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra |

Jaba Farmacêutica, S.A.

Zona Industrial da Abrunheira - Edifício Jaba - Rua da Tapada Grande, 2 2710-089 Sintra

Nimesulida Jabasulide 100 mg Granulado Para Solução Oral

100 mg

Trab għal soluzzjoni orali

Użu orali

Il-Portugall

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal

200 mg

Suppositorju

Użu għal ġor-rektum

Il-Portugall

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal 100 mg Granulado para Suspensão Oral

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Vetiquima - |
| --- |
| Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela |

Vetiquima -

Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela

21994 83 00

100 mg

Pillola

Użu orali

Il-Portugall

| Vetiquima - |
| --- |
| Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela |

Vetiquima -

Produtos Químicos, Lda. Estrada Nacional 10, Km 140,260 2696-901 Bobadela

21994 83 00

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Medicamed - |
| --- |
| Produtos Médicos e Farmacêuticos, S.A. Av. D. Afonso Henriques, 1462 - Edifício Olympus 4450-013 Matosinhos |

Medicamed -

Produtos Médicos e Farmacêuticos, S.A. Av. D. Afonso Henriques, 1462 - Edifício Olympus 4450-013 Matosinhos

Nimesulida Medicamed 100 mg Comprimidos

100 mg

Pillola miksija

Użu orali

Il-Portugall

| Medineo - Comercialização |
| --- |
| de Produtos Farmacêuticos, Lda. Rua Teófilo Braga, 14 2775-290 Parede |

Medineo - Comercialização

de Produtos Farmacêuticos, Lda. Rua Teófilo Braga, 14 2775-290 Parede

Nimesulida Medineo 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Mepha - Investigação, |
| --- |
| Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora |

Mepha - Investigação,

Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora

Nimesulida Mepha 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Mepha - Investigação, |
| --- |
| Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora |

Mepha - Investigação,

Desenvolvimento e Fabricação Farmacêutica, Lda. Rua Elias Garcia, 28 C - Edifício 4 - Venda Nova 2701-355 Amadora

Nimesulida Mepha 100 mg Granulado para Suspensão Oral

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa

100 mg

Pillola

Użu orali

Il-Portugall

Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa

Nimesulida Merck Genéricos 100 mg Granulado para solução oral

100 mg

Trab għal soluzzjoni orali

Użu orali

Il-Portugall

Tecnimede - Sociedade Técnico-Medicinal, S.A. Rua Prof. Henrique de Barros - Edifício Sagres - 3o A 2685-338 Prior Velho

Nimesulida Neuride 100 mg Comprimidos

100 mg

Pillola miksija

Użu orali

Il-Portugall

Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Nilmide 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Nilmide 100 mg Granulado Para Suspensão Oral

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

| Pharmakern Il-Portugall - |
| --- |
| Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Av. José Gomes Ferreira, 11 - 3o, Sala 31 - Edifício Atlas II 1495-139 Miraflores - Algés |

Pharmakern Il-Portugall -

Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Av. José Gomes Ferreira, 11 - 3o, Sala 31 - Edifício Atlas II 1495-139 Miraflores - Algés

Nimesulida Pharmakern 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Ranbaxy Il-Portugall - |
| --- |
| Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto |

Ranbaxy Il-Portugall -

Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto

Nimesulida Ranbaxy

100 mg

Pillola

Użu orali

Il-Portugall

| Ranbaxy Il-Portugall - |
| --- |
| Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto |

Ranbaxy Il-Portugall -

Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto

Nimesulida Ranbaxy

100 mg

Trab għal suspensjoni orali

Użu orali

Il-Portugall

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

Ratiopharm - Comércio e

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

Nimesulida Ratiopharm 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

| Quiraus - Comércio |
| --- |
| Produtos Químicos e Tecnologia Farmacêutica, Lda. Av. Salvador Allende, 12 - 1o 2780-163 Oeiras |

Quiraus - Comércio

Produtos Químicos e Tecnologia Farmacêutica, Lda. Av. Salvador Allende, 12 - 1o 2780-163 Oeiras

Nimesulida Reumesul 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

Sandoz Farmacêutica, Lda. Rua do Centro Empresarial - Edifício 3 - Loja 1 - Quinta da Beloura 2710-693 Sintra

Nimesulida Sandoz 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

Decafarma - Comércio de Produtos Farmacêuticos, Lda Centro Empresarial Sintra Estoril, V, Armazém E 3 2710-144 Sintra

Nimesulida Sulimed 100 mg Comprimidos

100 mg

Pillola

Użu orali

Il-Portugall

Laboratórios Atral, S.A Vala do Carregado 2600-726 Castanheira do Ribatejo

Ribantil

100 mg

Pillola miksija

Użu orali

Il-Portugall

| Pharmout - Farmacêutica |
| --- |
| Internacional, Lda. Rua da Quinta das Romeiras, 104 - 7o 1495-236 Algés |

Pharmout - Farmacêutica

Internacional, Lda. Rua da Quinta das Romeiras, 104 - 7o 1495-236 Algés

Vitolide

100 mg

Pillola

Użu orali

Ir-Rumanija

Faran Laboratories SA/Imedica SA, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti

AFLOGEN

100 mg

Pillola

Użu orali

Ir-Rumanija

Medochemie LTD, Str. Prof. Dr. Ion Cantacuzino nr. 5, sector 1, Bucuresti

Aponil

100 mg

Pillola

Użu orali

Ir-Rumanija

C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti

Aulin

100 mg

Granijiet għal suspensjoni orali

Użu orali

Ir-Rumanija

C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti

Aulin

100 mg

Pillola

Użu orali

Ir-Rumanija

Zentiva AS, B-dul Theodor Pallady nr. 50, 032266 Bucuresti

Coxtral

100 mg

Pillola

Użu orali

Ir-Rumanija

ANFARM HELLAS SA/Imedica, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti

Lemesil

100 mg

Pillola

Użu orali

Ir-Rumanija

| LABORATORI GUIDOTTI S.p.A., Via Livornese 897, |
| --- |
| I - 56010 La Vettola, PISA, L-Italja |

LABORATORI GUIDOTTI S.p.A., Via Livornese 897,

I - 56010 La Vettola, PISA, L-Italja

Nimesil

100 mg

Granijiet għal suspensjoni orali

Użu orali

Ir-Rumanija

Terapia SA, Str. Fabricii Nr.124, 3400 Cluj Napoca, Jud. Cluj

Nimesulid

100 mg

Pillola

Użu orali

Ir-Rumanija

LABORMED PHARMA SRL,Splaiul Independentei Nr. 319, Sector 6, Bucuresti

Nimesulid LPH 100 mg

100 mg

Pillola

Użu orali

Ir-Rumanija

MAGISTRA C & C, Str. Aviator Belghiru Nr. 9, 8700 Constanta, Jud. Constanta

Nimesulid 100 mg

100 mg

Pillola

Użu orali

Ir-Rumanija

ARENA GROUP SA, Str. Stefan Mihaileanu Nr.31, Sector 2, 73101 Bucuresti

Nimesulid Arena 100 mg

100 mg

Pillola

Użu orali

Ir-Rumanija

SLAVIA PHARM SRL, Str. Stirbei Voda Nr.53-55, Sector 1, Bucuresti

Nimesulid Slavia

100 mg

Pillola

Użu orali

Ir-Rumanija

FARMACEUTICI DAMUR SPA, Calea Dorobantilor Nr. 113 Ap.35, Cluj, Jud. Cluj

Sulidamor

100 mg

Trab għal suspensjoni orali

Użu orali

Is-Slovakkja

Medicom International s.r.o., Brno, Ir-Repubblika Ċeka

AULIN 100 mg granulát

100 mg

Granijiet

Użu orali

Is-Slovakkja

Medicom International s.r.o., Brno, Ir-Repubblika Ċeka

AULIN 100 mg tablety

100 mg

Pillola

Użu orali

Is-Slovakkja

Zentiva a.s., Praha, Ir-Repubblika Ċeka

COXTRAL

100 mg

Pillola

Użu orali

Is-Slovakkja

CSC Pharmaceuticals Handels GmbH, Wien, L-Awstrija

MESULID

100 mg

Pillola

Użu orali

Is-Slovakkja

Medicom International s.r.o., Brno, Ir-Repubblika Ċeka

NIMED

100 mg

Pillola

Użu orali

Is-Slovakkja

LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, L-Italja

Nimesil

100 mg

Granijiet għal suspensjoni orali

Użu orali

Slovenja

CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenja

Aulin

100 mg

Pillola

Użu orali

Slovenja

CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenja

Aulin

100 mg

Trab għal suspensjoni orali

Użu orali

Spanja

HELSINN BIREX PHARMACEUTICALS LTD Damastown Mulhuddart, County Dublin,15 L-Irlanda

GUAXAN 100 mg comprimidos

100 mg

Pillola

Użu orali

---

ANNESS X

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, QAWWIET TAL-PRODOTTI MEDIĊINALI, MNEJN JINGĦATA, ID-DETENTURI TA' L-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru EU/EEA | Id-Detentur ta’ l-Awtorizzazzjoni għat-tqegħid fis-suq | Isem (Ivvintat) | Qawwa | Għamla Farmaċewtika | Mnejn jingħata | Il-Kontenut
  (Konċentrat) |
| --- | --- | --- | --- | --- | --- | --- |
| Awstrija | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Wien |

Stat Membru EU/EEA

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

Isem (Ivvintat)

Qawwa

Għamla Farmaċewtika

Mnejn jingħata

Il-Kontenut

(Konċentrat)

Awstrija

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Wien

Augmentin intravenös 550 mg – Trockenstechampullen

500/50 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 50 mg/ kunjett

Augmentin intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung

1 000/100 mg

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1 000 mg: 100 mg/ kunjett

Augmentin intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung

2 000/200 mg

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ kunjett

Augmentin 625 mg - lösliche Tabletten

500/125 mg

Pillola li tinxtered

Użu orali

Augmentin

625 mg – Filmtabletten

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 1 g – Filmtabletten

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 457 mg/5 ml – Trockensaft

400/57 mg/ 5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

| Sandoz GmbH, Biochemiestr. 10, |
| --- |
| A - 6250 Kundl |

Sandoz GmbH, Biochemiestr. 10,

A - 6250 Kundl

Clavamox intravenös 550 mg – Trockenstechampullen

500/50 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 50 mg/ 10,5 ml

Clavamox intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung

1 000/100 mg

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

1 000 mg: 100 mg/ 100 ml

Clavamox intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung

2 000/200 mg

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ 100 ml

Clavamox 625 mg - lösliche Tabletten

500/125 mg

Pillola li tinxtered

Użu orali

Clavamox 625 mg – Filmtabletten

500/125 mg

Pillola miksija b’rita

Użu orali

Clavamox 1 g – Filmtabletten

875/125 mg

Pillola miksija b’rita

Użu orali

Clavamox 156,25 mg/5 ml – Trockensaft

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125/31,25 mg/ 5 ml

Clavamox 312,5 mg/5 ml – Trockensaft

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250/62,5 mg/ 5 ml

Clavamox Duo – Trockensaft

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400/57 mg/ 5 ml

Belġju

| GlaxoSmithKline s.a. / n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Augmentin P

500/50 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 50 mg/ 10.5 ml or 25 ml

Augmentin P

1 000/100 mg

Trab għall-infużjoni

Użu għal ġol-vini

1 000 mg:100 mg/ 50 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/ 20 ml

Augmentin

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ 100 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 ml

Augmentin

500/125 mg

Trab għal suspensjoni orali

Użu orali

Augmentin Retard

1 000/62,5 mg

Pillola li terħi l-mediċina b'mod modifikat

Użu orali

Bulgarija

| GlaxoSmithKline EOOD |
| --- |
| Ivan Vasov Complex |
| Dimitar Manov street, bl.10, 1408 Sofia, Bulgarija |

GlaxoSmithKline EOOD

Ivan Vasov Complex

Dimitar Manov street, bl.10, 1408 Sofia, Bulgarija

Augmentin

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/ 5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 ml

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Ċipru

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| Renju Unit |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

Renju Unit

Augmentin

500/100 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml or 60 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 000 mg: 200 mg/ 20,9 ml or 120 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 ml

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/ 5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

| Laboratórios BIAL |
| --- |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugall |

Laboratórios BIAL

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugall

Noprilam

500/125 mg

Pillola miksija b’rita

Użu orali

Noprilam DT

875/125 mg

Pillola miksija b’rita

Użu orali

Noprilam

156,23 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,23 mg/ 5 ml

Noprilam

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 ml

Noprilam DT

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Repubblika Ċeka

| SmithKline Beecham plc fil-kummerċ |
| --- |
| SmithKline Beecham Pharmaceuticals |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| Renju Unit |

SmithKline Beecham plc fil-kummerċ

SmithKline Beecham Pharmaceuticals

980 Great West Road,

Brentford, Middlesex

TW8 9GS

Renju Unit

Augmentin 600 mg

500/100 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml or 60 ml

Augmentin 1,2 g

1 000/200 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 000 mg: 200 mg/ 20,9 ml or 120 ml

| SmithKline Beecham plc fil-kummerċ |
| --- |
| SmithKline Beecham Pharmaceuticals |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| Renju Unit |

SmithKline Beecham plc fil-kummerċ

SmithKline Beecham Pharmaceuticals

980 Great West Road,

Brentford, Middlesex

TW8 9GS

Renju Unit

Augmentin 375 mg

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 625 mg

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 1 g

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 156 mg/5 ml

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin 312 mg/5 ml

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Augmentin Duo

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin SR

1 000/62,5 mg

Pillola li terħi l-mediċina b'mod modifikat

Użu orali

Danimarka

| Meda AS |
| --- |
| Solvang 8 |
| DK-3450 Allerød |
| Danimarka |

Meda AS

Solvang 8

DK-3450 Allerød

Danimarka

Spektramox

500/125 mg

Pillola miksija b’rita

Użu orali

Spektramox

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Spektramox

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Spektramox 2:1

250/125 mg

Pillola miksija b’rita

Użu orali

Spektraforte

875/125 mg

Pillola miksija b’rita

Użu orali

Estonja

| SmithKline Beecham plc. |
| --- |
| 980 Great West Road, Brentford |
| Middlesex TW8 9GS |
| Renju Unit |

SmithKline Beecham plc.

980 Great West Road, Brentford

Middlesex TW8 9GS

Renju Unit

Augmentin

1 000/200 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 000 mg: 200 mg/ 20,9 ml or 120 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/ 5 ml

Finlandja

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford, Middlesex TW8 9GS |
| Renju Unit |

SmithKline Beecham plc

980 Great West Road

Brentford, Middlesex TW8 9GS

Renju Unit

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin (80/11,97 mg/ml)

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Orion-yhtymä Oyj, Orionintie 1, 02200 Espoo

Clavurion

875/125 mg

Pillola miksija b’rita

Użu orali

Clavurion

200/28,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

200 mg: 28,5 mg/ 5 ml

Clavurion

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Franza

| Laboratoire GlaxoSmithKline |
| --- |
| 100, route de Versailles – 78163 Marly-le-Roi Cedex |

Laboratoire GlaxoSmithKline

100, route de Versailles – 78163 Marly-le-Roi Cedex

Augmentin IV

ENFANTS

NOURRISSONS

500/50 mg

Trab għal soluzzjoni għall-injezzjoni U

Trab u solvent għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

500 mg: 50 mg

Augmentin IV

ADULTES

500/100 mg

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg

Augmentin IV

ENFANTS

1 000/100 mg

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 100 mg

Augmentin IV

ADULTES

1 000/200 mg

Trab għal soluzzjoni għall-injezzjoni U

Trab u solvent għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg

Augmentin IV

ADULTES

2 000/200 mg

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

2 000 mg: 200 mg

Augmentin

ADULTES

500/62,5 mg

Pillola miksija b’rita

Użu orali

Augmentin

ENFANTS

100/12,5 mg/ml

Trab għal suspensjoni orali

Użu orali

100 mg: 12,5 mg/ ml

Augmentin

NOURRISSONS

100/12,5 mg/ml

Trab għal suspensjoni orali

Użu orali

100 mg / 12,5 mg/ ml

Augmentin

NOURRISSONS

250/31,25 mg

Trab għal suspensjoni orali

Użu orali

Augmentin

ENFANTS

500/62,5 mg

Trab għal suspensjoni orali

Użu orali

Augmentin

ADULTES

1 000/125 mg

Trab għal suspensjoni orali

Użu orali

Duamentin

ADULTES

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

Ġermanja

| GlaxoSmithKline GmbH & Co. KG |
| --- |
| Theresienhöhe 11 |
| 80339 München |

GlaxoSmithKline GmbH & Co. KG

Theresienhöhe 11

80339 München

Augmentan i.v. pro infantibus 275 mg

250/25 mg

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

250 mg 25 mg

Augmentan i.v. 600 mg

500/100 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 100 mg

Augmentan i.v. 1,2 g

1 000/200 mg

Trab għal soluzzjoni għall-infużjoni or infusion

Użu għal ġol-vini

1 000 mg: 200 mg

Augmentan i.v. 2,2 g

2 000/200 mg

Trab għal soluzzjoni għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg

Augmentan Tabs Tabletten

500/125 mg

Pillola li tinxtered

Użu orali

Augmentan Filmtabletten 875/125 mg

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentan Tropfen 50 mg/12,5 mg pro ml für Säuglinge

50/12,5 mg/ml

Trab għal suspensjoni orali

Użu orali

50 mg: 12,5/ ml

Augmentan Trockensaft 25 mg/6,25 mg pro ml

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentan forte Trockensaft 50 mg/12,5 mg pro ml

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Augmentan Kindersaft

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Greċja

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Athens |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Athens

Augmentin

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

500/125 mg

Pillola li tinxtered

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin SR

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 ml/5 ml

Ungerija

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43 |
| Ungerija |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43

Ungerija

Augmentin

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43. |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43.

Augmentin Duo

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin Duo

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin Duo

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin Extra

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 ml/ 5 ml

Augmentin Extra

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

Islanda

| GlaxoSmithKline ehf. |
| --- |
| Þverholti 14 |
| 105 Reykjavík. |

GlaxoSmithKline ehf.

Þverholti 14

105 Reykjavík.

Augmentin IV

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin IV

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Pillola

Użu orali

Augmentin

875/125 mg

Pillola

Użu orali

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Irlanda

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham, |
| Dublin 16 |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham,

Dublin 16

Augmentin

Intravenous 500 mg/100 mg Powder for Solution for Injection or Infusion

500/100 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin

Intravenous 1 000 mg/200 mg Powder for Solution for Injection or Infusion

1 000/200 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin Tablets 250 mg/125 mg

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin Dispersible Tablets 250 mg/125 mg

250/125 mg

Pillola li tinxtered

Użu orali

Augmentin Duo Tablets 500/125 mg

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 500/125 mg Film-Coated Tablets

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875 mg/125 mg Film Coated Tablets

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

Paediatric Suspension

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin

Junior Suspension

125/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 62,5 mg/ 5 ml

Augmentin Duo

Suspension 400 mg/57 mg

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel |
| Tipperary |
| Irlanda |

Clonmel Healthcare Limited

Waterford Road

Clonmel

Tipperary

Irlanda

Clavamel 250 mg/125 mg Tablets

250/125 mg

Pillola miksija b’rita

Użu orali

Clavamel 125 mg/31,25 mg Paediatric Powder for Oral Suspension

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Clavamel 125 mg/62,5 mg Junior Powder for Oral Suspension

125/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 62,5 mg/ 5 ml

Italja

| GlaxoSmithKline S.p.A. - Via A. Fleming, 2 – |
| --- |
| 37135 Verona |

GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –

37135 Verona

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/ 20 ml

Augmentin

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin

400/57 mg

Trab għal suspensjoni orali

Użu orali

Augmentin

875/125 mg

Trab għal suspensjoni orali

Użu orali

| Valeas S.p.A. |
| --- |
| via Vallisneri 10 |
| 20133 Milano |

Valeas S.p.A.

via Vallisneri 10

20133 Milano

Neoduplamox

875/125 mg

Pillola miksija b’rita

Użu orali

Neoduplamox

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Neoduplamox

400/57 mg

Trab għal suspensjoni orali

Użu orali

Neoduplamox

875/125 mg

Trab għal suspensjoni orali

Użu orali

| Solvay Pharma S.p.A. |
| --- |
| Via della Libertà, 30 |
| 10095 Grugliasco (TO) |

Solvay Pharma S.p.A.

Via della Libertà, 30

10095 Grugliasco (TO)

Clavulin

875/125 mg

Pillola miksija b’rita

Użu orali

Clavulin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Clavulin

400/57 mg

Trab għal suspensjoni orali

Użu orali

Clavulin

875/125 mg

Trab għal suspensjoni orali

Użu orali

Latvja

| GlaxoSmithKline Latvia SIA |
| --- |
| Bruninieku 5, Riga, LV-1001, Latvja |

GlaxoSmithKline Latvia SIA

Bruninieku 5, Riga, LV-1001, Latvja

Augmentin

1 000/200 mg

Trab għal soluzzjoni għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

Litwanja

| Beecham Group plc. |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| Renju Unit |

Beecham Group plc.

980 Great West Road

Brentford

Middlesex TW8 9GS

Renju Unit

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

200/28,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

200 mg/28,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg / 57 mg/ 5 ml

| UAB „GlaxoSmithKline Lietuva“ |
| --- |
| A. Goštauto g. 40A |
| LT-01112 Vilnius, Lithuania |

UAB „GlaxoSmithKline Lietuva“

A. Goštauto g. 40A

LT-01112 Vilnius, Lithuania

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg / 42,9 mg/ 5 ml

Lussemburgu

| GlaxoSmithKline s.a. / n.v. |
| --- |
| Rue du Tilleul 13 |
| 1332 Genval |

GlaxoSmithKline s.a. / n.v.

Rue du Tilleul 13

1332 Genval

Augmentin P

500/50 mg

Trab għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg / 50 mg/ 10,5 ml or 25 ml

Augmentin P

1 000/100 mg

Trab għall-infużjoni

Użu għal ġol-vini

1 000 mg /100 mg/ 50 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg / 200 mg/ 20 ml

Augmentin

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg / 200 mg/ 100 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Augmentin

500/125 mg

Trab għal suspensjoni orali

Użu orali

Augmentin Retard,

1 000/62,5 mg

Pillola li terħi l-mediċina b'mod modifikat

Użu orali

Malta

| Beecham Group plc |
| --- |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| Renju Unit |

Beecham Group plc

980 Great West Road,

Brentford, Middlesex

TW8 9GS

Renju Unit

Augmentin Intravenous 600 mg

500/100 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin Intravenous 1,2 g

1 000/200 mg

Trab għal soluzzjoni għall-injezzjoni jew infużjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham |
| Dublin 16 |
| Irlanda |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham

Dublin 16

Irlanda

Augmentin 250/125 mg

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin Duo 500/125 tablets

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 875/125 mg tablets

875/125 mg

Pillola miksija b’rita

Użu orali

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex |
| TW8 9GS |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

Augmentin Duo 400/57

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

| Laboratórios BIAL |
| --- |
| Portela & Ca, S.A. |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugall |

Laboratórios BIAL

Portela & Ca, S.A.

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugall

Noprilam

500/125 mg

Pillola miksija

Użu orali

Noprilam DT

875/125 mg

Pillola miksija

Użu orali

Noprilam DT

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400/57 mg/ 5 ml

Olanda

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| OLANDA |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

OLANDA

Augmentin

250/25 mg

Trab għall-injezzjoni

Użu għal ġol-vini

250 mg: 25 mg/ 5,2ml

Augmentin

500/50 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 50 mg/ 10,5 ml

Augmentin

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin

1 000/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg:100 mg/ 20,9 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ 120 ml

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

100/12,5 mg/ml

Trab għal suspensjoni orali

Użu orali

100 mg: 12,5 mg/ ml

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

| GlaxoSmith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| OLANDA |

GlaxoSmith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

OLANDA

amoxicilline/clavulaanzuur

250/62,5 mg

Trab għal suspensjoni orali

Użu orali

Poland

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| Renju Unit |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

Renju Unit

Augmentin

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ 120

Augmentin

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/ 5 ml

Augmentin

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 ml

Augmentin

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg : 42,9mg/ 5ml

Augmentin SR

1 000/62,5 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Portugall

| GlaxoSmithKline – Produtos Farmacêuticos Lda |
| --- |
| Rua Dr. António Loureiro Borges, 3 |
| Aquiparque – Miraflores |
| 1495 – 131 Algés |

GlaxoSmithKline – Produtos Farmacêuticos Lda

Rua Dr. António Loureiro Borges, 3

Aquiparque – Miraflores

1495 – 131 Algés

Augmentin

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin Duo

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin Forte

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 ml

Augmentin Duo

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 mg/5 ml

| Bial - Portela & Ca, S.A |
| --- |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugall |

Bial - Portela & Ca, S.A

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugall

Clavamox 125

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Clavamox 250

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Clavamox 500

500/125 mg

Pillola miksija b’rita

Użu orali

Clavamox DT

875/125 mg

Pillola miksija b’rita

Użu orali

Clavamox DT 400

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 ml/ 5 mg

Clavamox ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 ml/ 5 mg

Noprilam

500/125 mg

Pillola miksija b’rita

Użu orali

Noprilam

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/ 5 mg

Noprilam

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 mg

Noprilam DT

875/125 mg

Pillola miksija b’rita

Użu orali

| Laboratórios Vitória, S.A. Rua Elias Garcia, 28 – Venda Nova |
| --- |
| 2700-327 Amadora |
| (Sob licença GlaxoSmithKline – Produtos Farmacêuticos, Lda.) |

Laboratórios Vitória, S.A. Rua Elias Garcia, 28 – Venda Nova

2700-327 Amadora

(Sob licença GlaxoSmithKline – Produtos Farmacêuticos, Lda.)

Penilan

500/125 mg

Pillola miksija b’rita

Użu orali

Penilan

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/ 5 mg

Penilan DT

875/125 mg

Pillola miksija b’rita

Użu orali

Penilan Forte

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5 mg

Romanija

| Beecham Group PLC |
| --- |
| 980 Great West Road, Brentford, Middlesex TW8 9GS |
| Renju Unit |

Beecham Group PLC

980 Great West Road, Brentford, Middlesex TW8 9GS

Renju Unit

Augmentin

intravenos 1,2 g

1 000/200 mg

Trab għall-injezzjoni /infużjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin

Intravenos 2,2 g

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ 120

Augmentin 625 mg

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 1 g

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin BIS

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

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

Użu orali

Repubblika Slovakka

GlaxoSmithKline Slovakia sro., Galvaniho7/A, 82104 Bratislava, Slovakkja.

Augmentin 375 mg

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 625 mg

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 1 g

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin DUO

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Trab għal suspensjoni orali

Użu orali

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Pillola li terħi l-mediċina bil-mod

Użu orali

Slovenja

| GSK d.o.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| SI-1000 Ljubljana |
| Slovenja |

GSK d.o.o., Ljubljana

Knezov štradon 90

SI-1000 Ljubljana

Slovenja

Augmentin Augmentin 0,6 g prašek za raztopino za injiciranje ali infundiranje

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin 1,2 g prašek za raztopino za injiciranje ali infundiranje

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin 625 mg filmsko obložene tablete

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 1 000 mg filmsko obložene tablete

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 457 mg/5 ml prašek za peroralno suspenzijo

400/57 mg/5 ml

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Augmentin SR 1 000 mg/62,5 mg filmsko obložene tablete s podaljšanim sproščanjem

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

Spanja

| GlaxoSmithKline, S.A. |
| --- |
| P.T.M.- C/Severo Ochoa, 2 |
| 28760 Tres Cantos (Madrid). |

GlaxoSmithKline, S.A.

P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid).

Augmentine Intravenoso

500/50 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 50 mg/ 10,5 ml

Augmentine Intravenoso

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentine Intravenoso

2 000/200 mg

Trab għall-infużjoni

Użu għal ġol-vini

2 000 mg: 200 mg/ 120

Augmentine

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentine

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentine

100/12,5 mg/ml

Trab għal suspensjoni orali

Użu orali

100 mg:12,5 mg/ ml

Augmentine

500/125 mg

Trab għal suspensjoni orali

Użu orali

Augmentine

875/125 mg

Trab għal suspensjoni orali

Użu orali

Augmentine Plus

1 000/62,5 mg

Pillola miksija b’rita

Użu orali

| Laboratorios Beecham, S.A. |
| --- |
| P.T.M.- C/Severo Ochoa, 2 |
| 28760 Tres Cantos (Madrid). |

Laboratorios Beecham, S.A.

P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid).

Pangamox

250/62,5 mg

Trab għal suspensjoni orali

Użu orali

Pangamox

500/125 mg

Trab għal suspensjoni orali

Użu orali

Pangamox

875/125 mg

Trab għal suspensjoni orali

Użu orali

| Allen Farmacéutica, S.A.P.T.M.- C/Severo Ochoa, 2 |
| --- |
| 28760 Tres Cantos (Madrid). |

Allen Farmacéutica, S.A.P.T.M.- C/Severo Ochoa, 2

28760 Tres Cantos (Madrid).

Clavepen

500/125 mg

Pillola miksija b’rita

Użu orali

Clavumox

500/125 mg

Pillola miksija b’rita

Użu orali

Clavumox

875/125 mg

Pillola miksija b’rita

Użu orali

Clavumox

125/31,25 mg/5 ml

Suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Clavumox

250/62,5 mg

Trab għal suspensjoni orali

Użu orali

Clavepen

500/125 mg

Trab għal suspensjoni orali

Użu orali

Clavumox

500/125 mg

Trab għal suspensjoni orali

Użu orali

Clavumox

875/125 mg

Trab għal suspensjoni orali

Użu orali

Amoxicilina/Ác. Clavulanico ALLEN

875/125 mg

Trab għal suspensjoni orali

Użu orali

Svezja

| Meda AB |
| --- |
| Box 906 |
| 170 09 Sverige (SWE) |
| Svezja |

Meda AB

Box 906

170 09 Sverige (SWE)

Svezja

Spektramox

250/125 mg

(Amoxicillin: 250 mg)

Pillola miksija b’rita

Użu orali

Spektramox

500/125 mg

(Amoxicillin: 500 mg)

Pillola miksija b’rita

Użu orali

Spektramox

875/125 mg

(Amoxicillin 875 mg)

Pillola miksija b’rita

Użu orali

Spektramox

125/31,25 mg/5 ml

(Amoxicillin 25 mg/ml)

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Spektramox

125/31,25 mg

(Amoxicillin: 125 mg)

Trab għal suspensjoni orali

Użu orali

Spektramox

250/62,5 mg/5 ml

(Amoxicillin: 50 mg/ml)

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/ 5ml

Spektramox

400/57 mg/5 ml

(Amoxicillin: 80 mg/ml)

Trab għal suspensjoni orali

Użu orali

400 mg: 57 mg/5 ml

Renju Unit

| Beecham Group PLC |
| --- |
| SB House |
| Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| Renju Unit |

Beecham Group PLC

SB House

Great West Road

Brentford

Middlesex TW8 9GS

Renju Unit

Augmentin Intravenous 600 mg & 1,2 gm

500/100 mg

Trab għall-injezzjoni

Użu għal ġol-vini

500 mg: 100 mg/ 10,5 ml

Augmentin Intravenous 600 mg & 1,2 gm

1 000/200 mg

Trab għall-injezzjoni

Użu għal ġol-vini

1 000 mg: 200 mg/20,9 ml

Augmentin 375 mg Tablets

250/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 375 mg dispersible tablets

250/125 mg

Pillola li tinxtered

Użu orali

Augmentin 1 g Tablets

875/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 625 mg Tablets

500/125 mg

Pillola miksija b’rita

Użu orali

Augmentin 250/62 SF Suspension

250/62,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

250 mg: 62,5 mg/5 ml

Augmentin 125/31 SF Sachet

125/31,25 mg

Trab għal suspensjoni orali

Użu orali

Augmentin 125/31 SF Suspension

125/31,25 mg/5 ml

Trab għal suspensjoni orali

Użu orali

125 mg: 31,25 mg/5 ml

Augmentin Duo

200/28,5 mg/5 ml

Trab għal suspensjoni orali

Użu orali

200 mg: 28,5 mg/ 5 ml

---

ANNESS XI

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, DOŻAĠĠI, MODI TA' KIF TINGĦATA, APPLIKANT(I) U DETENTUR(I) TA' L-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq | Applikant | Isem (ivvintat) | Dożaġġ | Għamla farmaċewtika | Mod ta' kif tingħata |
| --- | --- | --- | --- | --- | --- | --- |
| Id-Danimarka | STADA Arzneimittel AG Stadastrasse 2-18 |
| 61118 Bad Vilbel, |
| il-Ġermanja |

Stat Membru

Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq

Applikant

Isem (ivvintat)

Dożaġġ

Għamla farmaċewtika

Mod ta' kif tingħata

Id-Danimarka

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel,

il-Ġermanja

Fentrans Depotplaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Ġermanja

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel, |
| il-Ġermanja |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel,

il-Ġermanja

Fentanyl-GRY

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

---

ANNESS XII

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, DOŻAĠĠI, MODI TA' KIF TINGĦATA, APPLIKANT(I) U DETENTUR(I) TA' L-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq | Applikant | Isem (ivvintat) | Dożaġġ | Għamla farmaċewtika | Mod ta' kif tingħata |
| --- | --- | --- | --- | --- | --- | --- |
| Id-Danimarka | STADA Arzneimittel AG |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| il-Ġermanja |

Stat Membru

Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq

Applikant

Isem (ivvintat)

Dożaġġ

Għamla farmaċewtika

Mod ta' kif tingħata

Id-Danimarka

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

il-Ġermanja

Matripain Depotplaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Ġermanja

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| il-Ġermanja |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

il-Ġermanja

Fentanyl AL

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

---

ANNESS XIII

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, DOŻAĠĠI, MODI TA' KIF TINGĦATA, APPLIKANT(I) U DETENTUR(I) TA' L-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq | Applikant | Isem (ivvintat) | Dożaġġ | Għamla farmaċewtika | Mod ta' kif tingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | | Teva Pharma B.V. |
| 3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217 |
| l-Olanda |

Stat Membru

Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq

Applikant

Isem (ivvintat)

Dożaġġ

Għamla farmaċewtika

Mod ta' kif tingħata

L-Awstrija

Teva Pharma B.V.

3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217

l-Olanda

Fentanyl TEVA transdermales Pflaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Belġju

| TEVA Pharma Belgium N.V |
| --- |
| B-2610 Wilrijk; Laarstraat 16, |
| il-Belġju |

TEVA Pharma Belgium N.V

B-2610 Wilrijk; Laarstraat 16,

il-Belġju

Fentanyl TEVA Pleister voor transdermaal gebruik

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Ir-Repubblika Ċeka

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1C |
| Praha 5 |
| ir-Repubblika Ċeka |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1C

Praha 5

ir-Repubblika Ċeka

Fentanyl - TEVA

25 μg/h

25 μg/h

Stikk transdermiku

Użu transdermiku

Fentanyl - TEVA

50 μg/h

50 μg/h

Fentanyl - TEVA

75 μg/h

75 μg/h

Fentanyl - TEVA

100 μg/h

100 μg/h

Id-Danimarka

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel |
| il-Ġermanja |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

il-Ġermanja

Matrigesic Depotplaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Estonja

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| l-Olanda |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

l-Olanda

Fentanyl - TEVA transdermalpatch

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Finlandja

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg, |
| l-Iżvezja |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg,

l-Iżvezja

Fentanyl TEVA

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Franza

| Société TEVA CLASSICS Immeuble Le Palatin 1; |
| --- |
| 1, Cours du Triangle; 92936 Paris La Défense Cedex, |
| Franza |

Société TEVA CLASSICS Immeuble Le Palatin 1;

1, Cours du Triangle; 92936 Paris La Défense Cedex,

Franza

Fentanyl TEVA dispositif transdermique

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Ungerija

| TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest |
| --- |
| L-Ungerija |

TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest

L-Ungerija

Fentanyl – Teva tapasz

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Italja

| TEVA Pharma Italia S.r.l. |
| --- |
| Via Giulio Richard, 7 20143 Milan |
| L-Italja |

TEVA Pharma Italia S.r.l.

Via Giulio Richard, 7 20143 Milan

L-Italja

Fentanil Teva cerotti transdermici

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Latvja

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| l-Olanda |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

l-Olanda

Fentanyl - TEVA transdermālie plāksteri

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Litwanja

| Teva Pharmaceuticals Europe B.V. |
| --- |
| Industrieweg 23, 3641 RK Mijdrecht |
| l-Olanda |

Teva Pharmaceuticals Europe B.V.

Industrieweg 23, 3641 RK Mijdrecht

l-Olanda

Fentanyl - TEVA

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Lussemburgu

| TEVA Pharma Belgium N.V |
| --- |
| B-2610 Wilrijk; Laarstraat 16, |
| il-Belġju |

TEVA Pharma Belgium N.V

B-2610 Wilrijk; Laarstraat 16,

il-Belġju

Fentanyl TEVA Dispositif transdermique

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Olanda

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| il-Ġermanja |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

il-Ġermanja

Fentanyl 25 microgram/uur PCH, pleister voor transdermaal gebruik

25 μg/h

Stikk transdermiku

Użu transdermiku

Fentanyl 50 microgram/uur PCH, pleister voor transdermaal gebruik

50 μg/h

Fentanyl 75 microgram/uur PCH, pleister voor transdermaal gebruik

75 μg/h

Fentanyl 100 microgram/uur PCH, pleister voor transdermaal gebruik

100 μg/h

In-Norveġja

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg |
| l-Iżvezja |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg

l-Iżvezja

Fentanyl TEVA

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Polonja

| TEVA PHARMACEUTICALS Polska Sp. Z.o.o. |
| --- |
| Emilii Plater 53, 00-113 |
| Warsaw |
| il-Polonja |

TEVA PHARMACEUTICALS Polska Sp. Z.o.o.

Emilii Plater 53, 00-113

Warsaw

il-Polonja

Fentanyl TEVA system transdermalny

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Portugall

| Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo |
| --- |
| il-Portugall |

Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo

il-Portugall

Fentanilo Teva

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

ir-Repubblika Slovakka

| Teva Pharmaceuticals CR, s.r.o |
| --- |
| Drazni 7; |
| 627 00 Brno |
| ir-Repubblika Ċeka |

Teva Pharmaceuticals CR, s.r.o

Drazni 7;

627 00 Brno

ir-Repubblika Ċeka

Fentanyl – TEVA

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Is-Slovenja

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| l-Olanda |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

l-Olanda

Fentanil TEVA transdermalni obliž

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Spanja

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzman el Bueno; 133. Edif. Britannia |
| 28003 Madrid |
| Spanja |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzman el Bueno; 133. Edif. Britannia

28003 Madrid

Spanja

Fentanilo TEVA parches transdermicos EFG

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

l-Iżvezja

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 51 10 Helsingborg, 2 |
| l-Iżvezja |

TEVA Sweden AB

PO Box 1070;

51 10 Helsingborg, 2

l-Iżvezja

Matrigesic transdermal patch

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Ir-Renju Unit

| TEVA UK Limited |
| --- |
| Brampton Road; Hampden Park; Eastbourne; East Sussex |
| BN22 9AG |
| ir-Renju Unit |

TEVA UK Limited

Brampton Road; Hampden Park; Eastbourne; East Sussex

BN22 9AG

ir-Renju Unit

Fentanyl Transdermal Patch

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

---

ANNESS XIV

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, DOŻAĠĠI, MODI TA' KIF TINGĦATA, APPLIKANT(I) U DETENTUR(I) TA' L-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq | Applikant | Isem (ivvintat) | Dożaġġ | Għamla farmaċewtika | Mod ta' kif tingħata |
| --- | --- | --- | --- | --- | --- | --- |
| Id-Danimarka | STADA Arzneimittel AG |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| il-Ġermanja |

Stat Membru

Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq

Applikant

Isem (ivvintat)

Dożaġġ

Għamla farmaċewtika

Mod ta' kif tingħata

Id-Danimarka

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

il-Ġermanja

Fentador

Depotplaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Ġermanja

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel, |
| il-Ġermanja |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel,

il-Ġermanja

Fentador

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

---

ANNESS XV

LISTA TA' L-ISMIJIET, GĦAMLIET FARMAĊEWTIĊI, DOŻAĠĠI, MODI TA' KIF TINGĦATA, APPLIKANT(I) U DETENTUR(I) TA' L-AWTORIZZAZZJONIJIET GĦAT-TQEGĦID FIS-SUQ FL-ISTATI MEMBRI

| Stat Membru | Detentur ta’ l-Awtorizzazzjoni għat-Tqegħid fis-Suq | Applikant/MAH | Isem (Ivvintat) | Dożaġġ | Għamla Farmaċewtika | Mnejn jingħata |
| --- | --- | --- | --- | --- | --- | --- |
| L-Awstrija | | STADA Arzneimittel GmbH |
| Muthgasse 36/2 |
| 1190 Wien |
| L-Awstrija |

Stat Membru

Detentur ta’ l-Awtorizzazzjoni għat-Tqegħid fis-Suq

Applikant/MAH

Isem (Ivvintat)

Dożaġġ

Għamla Farmaċewtika

Mnejn jingħata

L-Awstrija

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

L-Awstrija

Fentanyl STADA Depotpflaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Belġju

| Eurogenerics N.V., Heizel Esplanade Heysel b22 |
| --- |
| 1020 Brussels |
| Il-Belġju |

Eurogenerics N.V., Heizel Esplanade Heysel b22

1020 Brussels

Il-Belġju

Fentanyl EG Pleister voor transdermaal gebruik

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Ir-Repubblika Ċeka

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentanyl STADA

25 μg/h

25 μg/h

Stikk transdermiku

Użu transdermiku

Fentanyl STADA

50 μg/h

50 μg/h

Fentanyl STADA

75 μg/h

75 μg/h

Fentanyl STADA

100 μg/h

100 μg/h

Id-Danimarka

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentastad depotplaster

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Estonja

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentaderm transdermal patch

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Finlandja

| STADA Arzneimittel AG Stadastrasse 2-18, |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18,

61118 Bad Vilbel

Il-Ġermanja

Fentanyl STADA

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Franza

| EGLABO |
| --- |
| Le Quintet-Bat A |
| 12 rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Franza |

EGLABO

Le Quintet-Bat A

12 rue Danjou

92517 Boulogne Billancourt Cedex

Franza

Fentanyl EG LABO, dispositif transdermique

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Ungerija

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentanyl STADA tapasz

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Italja

| EG S.p.A. |
| --- |
| Via D. Scarlatti, 31 |
| 20124 Milano |
| L-Italja |

EG S.p.A.

Via D. Scarlatti, 31

20124 Milano

L-Italja

Nilafen cerotti transdermici

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Latvja

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentastad transdermālie plāksteri

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Litwanja

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentaderm

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Lussemburgu

| Eurogenerics N.V., Heizel Esplanade Heysel b22, |
| --- |
| 1020 Brussels |
| Il-Belġju |

Eurogenerics N.V., Heizel Esplanade Heysel b22,

1020 Brussels

Il-Belġju

Fentanyl EG pleister voor transdermal gebruik

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Olanda

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentanyl CF 25 microgram/uur, pleister voor transdermaal gebruik

25 μg/h

Stikk transdermiku

Użu transdermiku

Fentanyl CF50 microgram/uur, pleister voor transdermaal gebruik

50 μg/h

Fentanyl CF 75 microgram/uur, pleister voor transdermaal gebruik

75 μg/h

Fentanyl CF 100 microgram/uur, pleister voor transdermaal gebruik

100 μg/h

Il-Polonja

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentanyl STADA

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Il-Portugall

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos |
| Il-Portugall |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos

Il-Portugall

Fentanilo Ciclum

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Ir-Repubblika Slovakka

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentanyl STADA transdermálna náplasť

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Spanja

| Lab. STADA |
| --- |
| Frederic Mompou,5 |
| 08960 Sant Just Desvern, Barcelona |
| Spanja |

Lab. STADA

Frederic Mompou,5

08960 Sant Just Desvern, Barcelona

Spanja

Fentanilo STADA parches transdermicos EFG

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

L-Iżvezja

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Il-Ġermanja |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Il-Ġermanja

Fentanyl STADA Transdermal Patch

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

Ir-Renju Unit

| Genus Pharmaceuticals Ltd. |
| --- |
| (trading as Genus Pharmaceuticals) |
| Benham, Valence, Newbury |
| Berkshire, RG20 8LU |
| Ir-Renju Unit |

Genus Pharmaceuticals Ltd.

(trading as Genus Pharmaceuticals)

Benham, Valence, Newbury

Berkshire, RG20 8LU

Ir-Renju Unit

Fentanyl Transdermal Patch

25 μg/h

Stikk transdermiku

Użu transdermiku

50 μg/h

75 μg/h

100 μg/h

---