# Uradni list C 288/2009

| | ISSN 1725-5244
  doi:10.3000/17255244.C_2009.288.slv |
| --- | --- |
| Uradni list
  Evropske unije | C 288 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5227. november 2009 |

ISSN 1725-5244

doi:10.3000/17255244.C_2009.288.slv

Uradni list

Evropske unije

C 288

Slovenska izdaja

Informacije in objave

Zvezek 5227. november 2009

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| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ IN ORGANOV EVROPSKE UNIJE |
| | Komisija |
| 2009/C 288/01 | Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. oktobra 2009 do 31. oktobra 2009(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
  ) | 1 |
| 2009/C 288/02 | Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. oktobra 2009 do 31. oktobra 2009(Odločbe, sprejete na podlagi člena 34 Direktive 2001/83/ES Evropskega parlamenta in Sveta
  oziroma člena 38 Direktive 2001/82/ES Evropskega parlamenta in Sveta
  ) | 11 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ IN ORGANOV EVROPSKE UNIJE

Komisija

2009/C 288/01

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. oktobra 2009 do 31. oktobra 2009(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
  )

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta

)

1

2009/C 288/02

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. oktobra 2009 do 31. oktobra 2009(Odločbe, sprejete na podlagi člena 34 Direktive 2001/83/ES Evropskega parlamenta in Sveta
  oziroma člena 38 Direktive 2001/82/ES Evropskega parlamenta in Sveta
  )

(Odločbe, sprejete na podlagi člena 34 Direktive 2001/83/ES Evropskega parlamenta in Sveta

oziroma člena 38 Direktive 2001/82/ES Evropskega parlamenta in Sveta

)

11

| SL | |
| --- | --- |

SL

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IV Informacije

INFORMACIJE INSTITUCIJ IN ORGANOV EVROPSKE UNIJE

Komisija

| 27.11.2009 | SL | Uradni list Evropske unije | C 288/1 |
| --- | --- | --- | --- |

27.11.2009

SL

Uradni list Evropske unije

C 288/1

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Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. oktobra 2009 do 31. oktobra 2009

(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (1)
  )

2009/C 288/01

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004): Odobrena

| Datum sprejetja odločbe | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | Oznaka ATC (anatomsko terapevtsko kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.10.2009 | Onglyza | saksagliptina | 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 | Filmsko obložene tablete | 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 | raztopina za injiciranje-subkutana uporaba | L04AB05 | 6.10.2009 |
| 1.10.2009 | Simponi | golimumaba | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | EU/1/09/546/001-004 | raztopina za injiciranje v napolnjenem peresniku | L04AB06 | 6.10.2009 |
| 5.10.2009 | ChondroCelect | Karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine | TiGenix NV, Romeinse straat 12/2, B-3001 LEUVEN, België | EU/1/09/563/001 | Celična suspenzija za implantacijo | se ne uporablja | 7.10.2009 |
| 14.10.2009 | Enyglid | repaglinid | KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/580/001-018 | Tablete | A10B X02 | 16.10.2009 |
| 15.10.2009 | Resolor | prukaloprid | Movetis NV, Veedijk 58, B-2300 Turnhout, België | EU/1/09/581/001-002 | Filmsko obložene tablete | A03AE04 | 19.10.2009 |
| 15.10.2009 | Imprida HCT | amlodipinijev besilat / valsartan / hidroklorotiazid | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/570/001-060 | filmsko obložena tableta | C09DX01 | 19.10.2009 |
| 16.10.2009 | Clopidogrel MYLAN Pharma | klopidogrel | Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France | EU/1/09/568/001-018 | Filmsko obložena tableta | B01AC-04 | 20.10.2009 |
| 16.10.2009 | PANDEMIC INFLUENZA VACCINE H5N1 BAXTER | Cepivo proti pandemični gripi (celoten viron H5N1, razmnožen v celicah Vero, inaktiviran) | Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich | EU/1/09/571/001 | suspenzija za injiciranje | J07BB01 | 20.10.2009 |
| 16.10.2009 | Exforge HCT | amlodipinijev besilat / valsartan / hidroklorotiazid | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569/001-060 | filmsko obložena tableta | C09DX01 | 20.10.2009 |
| 16.10.2009 | ALENDRONATE SODIUM AND COLECALCIFEROL, MSD | alendronska kislina / holekalciferol | Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572/001-009 | Tableta | M05BB03 | 20.10.2009 |
| 19.10.2009 | Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals | Prečiščena antigenska frakcija inaktiviranih delcev virionov A/VietNam/1194/2004 NIBRG-14 (H5N1) | GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578/001 | suspenzija in emulzija za emulzijo za injiciranje | J07BB02 | 21.10.2009 |
| 19.10.2009 | Foclivia | Površinski antigeni seva virusa influence A/Vietnam/1194/2004 (H5N1) | Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina, 1 - Siena, Italia | EU/1/09/577/001-004 | Suspenzija za injiciranje | J07BB02 | 21.10.2009 |
| 23.10.2009 | Lamivudine Teva | lamivudina | Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland | EU/1/09/566/001-005 | filmsko obložene tablete | 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 | Raztopina za injiciranje | 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 | prašek in vehikel za raztopino za injiciranje | L04AC04 | 27.10.2009 |
| 23.10.2009 | ILARIS | kanakinumab | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564/001-002 | prašek za raztopino za injiciranje | 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 | Raztopina za injiciranje | 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 | Filmsko obložena tableta | C09C A04 | 4.11.2009 |

Datum sprejetja odločbe

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

Oznaka ATC (anatomsko terapevtsko kemijska oznaka)

Datum obvestila

1.10.2009

Onglyza

saksagliptina

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

Filmsko obložene tablete

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

raztopina za injiciranje-subkutana uporaba

L04AB05

6.10.2009

1.10.2009

Simponi

golimumaba

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

EU/1/09/546/001-004

raztopina za injiciranje v napolnjenem peresniku

L04AB06

6.10.2009

5.10.2009

ChondroCelect

Karakterizirane viabilne avtologne hrustančne celice, ekspandirane ex vivo, ki izražajo specifične markerske proteine

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

EU/1/09/563/001

Celična suspenzija za implantacijo

se ne uporablja

7.10.2009

14.10.2009

Enyglid

repaglinid

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

EU/1/09/580/001-018

Tablete

A10B X02

16.10.2009

15.10.2009

Resolor

prukaloprid

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

EU/1/09/581/001-002

Filmsko obložene tablete

A03AE04

19.10.2009

15.10.2009

Imprida HCT

amlodipinijev besilat / valsartan / hidroklorotiazid

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

EU/1/09/570/001-060

filmsko obložena tableta

C09DX01

19.10.2009

16.10.2009

Clopidogrel MYLAN Pharma

klopidogrel

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

EU/1/09/568/001-018

Filmsko obložena tableta

B01AC-04

20.10.2009

16.10.2009

PANDEMIC INFLUENZA VACCINE H5N1 BAXTER

Cepivo proti pandemični gripi (celoten viron H5N1, razmnožen v celicah Vero, inaktiviran)

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

EU/1/09/571/001

suspenzija za injiciranje

J07BB01

20.10.2009

16.10.2009

Exforge HCT

amlodipinijev besilat / valsartan / hidroklorotiazid

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

EU/1/09/569/001-060

filmsko obložena tableta

C09DX01

20.10.2009

16.10.2009

ALENDRONATE SODIUM AND COLECALCIFEROL, MSD

alendronska kislina / holekalciferol

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

EU/1/09/572/001-009

Tableta

M05BB03

20.10.2009

19.10.2009

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

Prečiščena antigenska frakcija inaktiviranih delcev virionov A/VietNam/1194/2004 NIBRG-14 (H5N1)

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

EU/1/09/578/001

suspenzija in emulzija za emulzijo za injiciranje

J07BB02

21.10.2009

19.10.2009

Foclivia

Površinski antigeni seva virusa influence A/Vietnam/1194/2004 (H5N1)

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

EU/1/09/577/001-004

Suspenzija za injiciranje

J07BB02

21.10.2009

23.10.2009

Lamivudine Teva

lamivudina

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

EU/1/09/566/001-005

filmsko obložene tablete

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

Raztopina za injiciranje

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

prašek in vehikel za raztopino za injiciranje

L04AC04

27.10.2009

23.10.2009

ILARIS

kanakinumab

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

EU/1/09/564/001-002

prašek za raztopino za injiciranje

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

Raztopina za injiciranje

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

Filmsko obložena tableta

C09C A04

4.11.2009

—   Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004): Odobrena

| Datum sprejetja odločbe | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 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 |

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Preklic ukinitve dovoljenja za promet (člen 20 Uredbe (ES) št. 726/2004)

| Datum sprejetja odločbe | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 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 |

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

—   Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004): Odobrena

| Datum sprejetja odločbe | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 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 |

Datum sprejetja odločbe

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

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

Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih odločb zdravil, se lahko obrne na naslov:

| The European Medicines Agency |
| --- |
| 7, Westferry Circus, Canary Wharf |
| London E14 4HB |
| UNITED KINGDOM |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

London E14 4HB

UNITED KINGDOM

---

(1)  UL L 136, 30.4.2004, str 1.

---

| 27.11.2009 | SL | Uradni list Evropske unije | C 288/11 |
| --- | --- | --- | --- |

27.11.2009

SL

Uradni list Evropske unije

C 288/11

---

Povzetek odločb Skupnosti o dovoljenjih za promet z zdravili od 1. oktobra 2009 do 31. oktobra 2009

(Odločbe, sprejete na podlagi člena 34 Direktive 2001/83/ES Evropskega parlamenta in Sveta
   (1)
  oziroma člena 38 Direktive 2001/82/ES Evropskega parlamenta in Sveta
   (2)
  )

2009/C 288/02

-   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja odločbe | Ime zdravila | Imetnik(i) dovoljenja za promet | Zadevne države članice | Datum obvestila |
| --- | --- | --- | --- | --- |
| 1.10.2009 | Simponi | Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland | Ta odločba je naslovljena na države članice | 5.10.2009 |
| 1.10.2009 | Ivermectin | Glej Prilogo I | Glej Prilogo I | 5.10.2009 |
| 1.10.2009 | Topamax | Glej Prilogo II | Glej PrilogoII | 5.10.2009 |
| 1.10.2009 | Cimzia | UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | Ta odločba je naslovljena na države članice | 5.10.2009 |
| 2.10.2009 | Avalox | Glej Prilogo III | Glej Prilogo III | 6.10.2009 |
| 2.10.2009 | Octegra | Glej Prilogo IV | Glej Prilogo IV | 6.10.2009 |
| 5.10.2009 | ChondroCelect | TiGenix NV, Romeinse straat 12/2, B-3001 LEUVEN, België | Ta odločba je naslovljena na države članice | 6.10.2009 |
| 6.10.2009 | Fentrix | Glej Prilogo V | Glej Prilogo V | 7.10.2009 |
| 15.10.2009 | Meronem | Glej Prilogo VI | Glej Prilogo VI | 19.10.2009 |
| 15.10.2009 | Pulmotil AC | Glej Prilogo VII | Glej Prilogo VII | 19.10.2009 |
| 15.10.2009 | Pulmotil 40 VET Premix, Pulmotil 100 VET Premix, Pulmotil 200 VET Premix | Glej Prilogo VIII | Glej Prilogo VIII | 19.10.2009 |
| 16.10.2009 | Nimesulide | Glej Prilogo IX | Glej Prilogo IX | 19.10.2009 |
| 19.10.2009 | Augmentin | Glej Prilogo X | Glej Prilogo X | 21.10.2009 |
| 23.10.2009 | ILARIS | Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Ta odločba je naslovljena na države članice | 26.10.2009 |
| 23.10.2009 | ARCALYST | Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom | Ta odločba je naslovljena na države članice | 26.10.2009 |

Datum sprejetja odločbe

Ime zdravila

Imetnik(i) dovoljenja za promet

Zadevne države članice

Datum obvestila

1.10.2009

Simponi

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

Ta odločba je naslovljena na države članice

5.10.2009

1.10.2009

Ivermectin

Glej Prilogo I

Glej Prilogo I

5.10.2009

1.10.2009

Topamax

Glej Prilogo II

Glej PrilogoII

5.10.2009

1.10.2009

Cimzia

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

Ta odločba je naslovljena na države članice

5.10.2009

2.10.2009

Avalox

Glej Prilogo III

Glej Prilogo III

6.10.2009

2.10.2009

Octegra

Glej Prilogo IV

Glej Prilogo IV

6.10.2009

5.10.2009

ChondroCelect

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

Ta odločba je naslovljena na države članice

6.10.2009

6.10.2009

Fentrix

Glej Prilogo V

Glej Prilogo V

7.10.2009

15.10.2009

Meronem

Glej Prilogo VI

Glej Prilogo VI

19.10.2009

15.10.2009

Pulmotil AC

Glej Prilogo VII

Glej Prilogo VII

19.10.2009

15.10.2009

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

Glej Prilogo VIII

Glej Prilogo VIII

19.10.2009

16.10.2009

Nimesulide

Glej Prilogo IX

Glej Prilogo IX

19.10.2009

19.10.2009

Augmentin

Glej Prilogo X

Glej Prilogo X

21.10.2009

23.10.2009

ILARIS

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

Ta odločba je naslovljena na države članice

26.10.2009

23.10.2009

ARCALYST

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

Ta odločba je naslovljena na države članice

26.10.2009

-   Preklic nacionalnega dovoljenja za promet

| Datum sprejetja odločbe | Ime zdravila | Imetnik(i) dovoljenja za promet | Zadevne države članice | Datum obvestila |
| --- | --- | --- | --- | --- |
| 30.10.2009 | Fentrans | Glej Prilogo XI | Glej Prilogo XI | 4.11.2009 |
| 30.10.2009 | Matripain | Glej Prilogo XII | Glej Prilogo XII | 4.11.2009 |
| 30.10.2009 | Matrigesic | Glej Prilogo XIII | Glej Prilogo XIII | 4.11.2009 |
| 30.10.2009 | Fentador | Glej Prilogo XIV | Glej Prilogo XIV | 4.11.2009 |
| 30.10.2009 | Fentastad | Glej Prilogo XV | Glej Prilogo XV | 4.11.2009 |

Datum sprejetja odločbe

Ime zdravila

Imetnik(i) dovoljenja za promet

Zadevne države članice

Datum obvestila

30.10.2009

Fentrans

Glej Prilogo XI

Glej Prilogo XI

4.11.2009

30.10.2009

Matripain

Glej Prilogo XII

Glej Prilogo XII

4.11.2009

30.10.2009

Matrigesic

Glej Prilogo XIII

Glej Prilogo XIII

4.11.2009

30.10.2009

Fentador

Glej Prilogo XIV

Glej Prilogo XIV

4.11.2009

30.10.2009

Fentastad

Glej Prilogo XV

Glej Prilogo XV

4.11.2009

---

(1)  UL L 311, 28.11.01, str. 67.

(2)  UL L 311, 28.11.01, str. 1.

---

DODATEK I

SEZNAM IMEN, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, NAČINOV UPORABE ZDRAVILA, PRIPOROČENIH ODMERKOV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom in naslov | Izmišljeno ime | Jakosti | Živalske vrste | Pot uporabe zdravila | Priporočeni odmerek |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Chanelle Animal Health Ltd |
| 7 Rodney Street |
| Liverpool |
| L1 9HZ |
| United Kingdom |

Država članica

Imetnik dovoljenja za promet z zdravilom in naslov

Izmišljeno ime

Jakosti

Živalske vrste

Pot uporabe zdravila

Priporočeni odmerek

Avstrija

Chanelle Animal Health Ltd

7 Rodney Street

Liverpool

L1 9HZ

United Kingdom

Animec injection Injektionslöng für Rinder und Schweine

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Avstrija

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Avstrija

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Belgija

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

BOVIMEC B

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Belgija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Belgija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Belgija

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

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

IVOMEC F

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Belgija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Belgija

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Belgija

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Belgija

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

MERIAL Belgium S.A.

Bld Sylvain Dupuis 243

1070 Bruxelles

Belgium

Ivomec

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Belgija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Belgija

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Bolgarija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Bolgarija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Bolgarija

| 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 %

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Bolgarija

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

BIOVET JSC

39 Petar Rakov Str.

4550 Pesthera

Bulgaria

Pandex 1 %

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Bolgarija

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

Centrovet Ltd.

Av.Los Cerrilos 602

Santiago,

Chile

Microdes Plus

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Bolgarija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Bolgarija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Bolgarija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Ciper

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

Panchris Feeds Ltd.

P.O.Box 40261,

6302 Larnaca

Cyprus

Bimectin Injection

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Ciper

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Ciper

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

Spyros Stavrinides Chemicals Ltd

28 Stasinou Avenue,

1060 Nicosia,

Cyprus

Noromectin injection

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

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

Vétoquinol s.r.o.,

Zámečnícka 411,

288 02 Nymburk,

Czech Republic

Biomectin 1 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

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

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

| 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.

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 % inj. ad. us. vet.

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Super inj. a.u.v.

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Češka republika

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

| 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.

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Češka republika

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Danska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Danska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Danska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Danska

| 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.

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Danska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Danska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Danska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 %

injection, süstelahus

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

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

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Estonija

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Finska

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

Scanvet Eläinlääkkeet Oy

PL 27

13721 PAROLA

Finland

Animec vet

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Finska

| 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

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Finska

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec

10 mg/ml vet injektioneste, liuos

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Finska

| 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 10 mg/ml solution for injection

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Finska

| 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 10 mg/ml

Solution for Injection

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Finska

| 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

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Francija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC D

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Francija

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Francija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

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

MERIAL GmbH

Am Söldnermoos 6

D-85399 Hallbergmoos

Germany

Ivomec

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nemčija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Grčija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

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

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Inj. Sol.

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

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

VETERIN ABEE

Aspropyrgos Attikis

19300

Greece

VETERMEC

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

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

PNG Gerolymatos S.A.

13, Asklipiou

145 68 KRYONERI, ATTICA

Greece

VALANEQ

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

MAXIMEC

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Grčija

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

SCHERING PLOUGH SA

65,Ag Dimitriou

17455, Athens

Greece

TIZOVAL

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Madžarska

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

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Injection

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

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

Bayer Hungária Ltd.

H-1123 Budapest

Alkotás u. 50.

Hungary

Baymec Trio 1 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

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

Bremer Pharma GmbH.

Werkstrasse 42

34414 Warburg-Scherfede

Germany

FROMMECTIN

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

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

Veterina Polska Sp. Zo.o.

Ul. Mogilska 80,

31546 Krakow

Poland

Iverktin Injection

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec injekció A.U.V.

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec super injekció A.U.V.

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Madžarska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Madžarska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM 2 mg klorsulona/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Trimectin Injection

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bovimec 1 % w/v Solution for Injection for Cattle

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Irska

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Islandija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec vet.

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Italija

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

INTERVET PRODUCTIONS SRL

Via Nettunense km 20, 300

04011 Aprilia

Italy

Ivogell

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Italija

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec iniettable

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

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

Fatro

Via Emilia, 285

40064 Ozzano Emilia (Bologna)

Italy

Tolomec

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Italija

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Italija

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Italija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Latvija

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

Chanelle Pharmaceuticals Manufacturing Ltd.,

Loughrea, Co. Galway,

Ireland

Animec Injection

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC 1 % Injection

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Plus

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Latvija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Latvija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC PLUS, injekcinis tirpalas

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Litva

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC 1 %, injekcinis tirpalas

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

| 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

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Litva

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Luksemburg

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Luksemburg

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Luksemburg

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Luksemburg

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Luksemburg

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Luksemburg

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Malta

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

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

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nizozemska

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

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Ivomec

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

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

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Ivomec Plus

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Nizozemska

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

Merial B.V.

Kleermakerstraat 10

1991 JL Velserbroek

The Netherlands

Panomec Injectievloeistof

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Euromec Injectie

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Maximec Injectie

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Nizozemska

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Bimectin Injectie

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Nizozemska

| 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 10 mg/ml oplossing voor injectie

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

| 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/g solution for injection

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Nizozemska

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

Dopharma Research B.V.

Zalmweg 24

4941 VX Raamsdonksveer

The Netherlands

Iverveto 1 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Norveška

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec vet, injeksjonsvæske, oppløsning 10 mg/ml

Ivermektin 10 mg/ml

Govedo, ovce, jeleni, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Norveška

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Norveška

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Poljska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Portugalska

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Portugalska

| 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 %

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Portugalska

| 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 %

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Portugalska

| 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 %

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Portugalska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Portugalska

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Romunija

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

BIOVET JSC

39 Petar Rakov Str.

4550 Pesthera

Bulgaria

Pandex 1 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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.

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

Bremer Pharma GmbH

Cherbourger Str. 25

27540 Bremerhaven

Germany

Bremamectin

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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.

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

FARMAVET S.A.

Str. Petricani 198,

Chișinău

Republica Moldova

Ivermectina 1 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

HEMOFARM – HEMOVET

Beogradski Put BB

Vrsac

Serbia

Ivermektin S

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

INTERVET PRODUCTIONS SRL

Via Nettunense km 20, 300

04011 Aprilia

Italy

Ivogell

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

PANTEX

Ganzestaartsedijk 8 – 5525 KC Duizel

The Netherlands

Panmectin 10

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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 %

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

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

SYVA

Av. Párroco Pablo Diez, 49 – 57

24010 – Leon

Spain

Zoomectin

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Romunija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Slovaška republika

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

Vétoquinol s.r.o.,

Zámečnícka 411,

288 02 Nymburk,

Czech Republic

Biomectin

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovaška republika

| 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.

Ivermektin 10 mg/ml

Govedo, ovce, koze, prašiči

Subkutana

| Govedo, ovce, koze: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce, koze:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovaška republika

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovaška republika

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec 1 % inj. ad us.vet.

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovaška republika

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec Super inj. ad us.vet.

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Slovaška republika

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovaška republika

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovaška republika

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Slovenija

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

VET4VET d.o.o.

Gerbičeva 50,

1000 Ljubljana

Slovenia

Animec Injection

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovenija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Slovenija

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

IVOMEC solution for injection

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

TIZOVAL

VACUNO INYECTABLE

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Španija

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Španija

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Švedska

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

MERIAL

29 avenue Tony Garnier

69007 LYON

France

Ivomec® vet.

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Švedska

| 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

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Švedska

| 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.

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Švedska

| 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 10 mg/ml

Ivermektin 10 mg/ml

Govedo, jeleni, prašiči

Subkutana

| Govedo, jeleni: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, jeleni:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Švedska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Švedska

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce

Subkutana

200 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klorsulona/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml,

klorsulon 100 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 2 mg klorsulona/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Ecomec 1 % Injection

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

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

Cross Vetpharm Group Ltd,

Broomhill Road

Tallaght

Dublin 24

Ireland

Qualimintic 1 % Injection

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, prašiči

Subkutana

| Govedo: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 10 mg/ml

Govedo, ovce, prašiči

Subkutana

| Govedo, ovce: | 200 μg ivermektina/kg TM |
| --- | --- |
| Prašiči: | 300 μg ivermektina/kg TM |

Govedo, ovce:

200 μg ivermektina/kg TM

Prašiči:

300 μg ivermektina/kg TM

Združeno kraljestvo

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Združeno kraljestvo

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

Združeno kraljestvo

| 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

Ivermektin 5 mg/ml,

klosantel 125 mg/ml

Govedo

Subkutana

200 μg ivermektina/kg TM, 5 mg klosantela/kg TM

---

DODATEK II

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica (EU/EGP) | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Janssen-Cilag Pharma GmbH |
| Pfarrgasse 75 A-1232 Wien, Avstrija |

Država članica (EU/EGP)

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 100 mg – Filmtabletten

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Avstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 200 mg - Filmtabletten

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Avstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 25 mg - Filmtabletten

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Avstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 50 mg - Filmtabletten

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Avstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 15 mg - Granulat in Kapseln

15 miligramov

granule v kapsuli

Peroralna uporaba

Avstrija

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

Janssen-Cilag Pharma GmbH

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 25 mg - Granulat in Kapseln

25 miligramov

granule v kapsuli

Peroralna uporaba

Avstrija

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

Janssen-Cilag Pharma GmbH -

Pfarrgasse 75 A-1232 Wien, Avstrija

Topamax 50 mg - Granulat in Kapseln

50 miligramov

granule v kapsuli

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 15mg harde capsules

15 miligramov

Trda kapsula

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 25mg harde capsules

25 miligramov

Trda kapsula

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 50mg harde capsules

50 miligramov

Trda kapsula

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 100mg tabletten

100 miligramov

Tableta

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 200mg tabletten

200 miligramov

Tableta

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 25mg tabletten

25 miligramov

Tableta

Peroralna uporaba

Belgija

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

Janssen-Cilag NV – BE

Roderveldlaan 1 B-2600 Berchem, Belgija

Topamax 50mg tabletten

50 miligramov

Tableta

Peroralna uporaba

Bolgarija

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

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

Smartinska cesta 53, 1000 Ljubljana, Slovenija

TOPAMAX

15 miligramov

Kapsula

Peroralna uporaba

Bolgarija

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

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

Smartinska cesta 53, 1000 Ljubljana, Slovenija

TOPAMAX

25 miligramov

Kapsula

Peroralna uporaba

Bolgarija

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

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

Smartinska cesta 53, 1000 Ljubljana, Slovenija

TOPAMAX

100 miligramov

Tableta

Peroralna uporaba

Bolgarija

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

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

Smartinska cesta 53, 1000 Ljubljana, Slovenija

TOPAMAX

25 miligramov

Tableta

Peroralna uporaba

Bolgarija

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

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

Smartinska cesta 53, 1000 Ljubljana, Slovenija

TOPAMAX

50 miligramov

Tableta

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 100 mg tabs

100 miligramov

Tableta

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 200 mg tabs

200 miligramov

Tableta

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 25 mg tabs

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 50 mg tabs

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 15 mg Sprinkles

15 miligramov

Kapsula

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 25 mg Sprinkles

25 miligramov

Kapsula

Peroralna uporaba

Ciper

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

TOPAMAX 50 mg Sprinkles

50 miligramov

Kapsula

Peroralna uporaba

Češka

| 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 miligramov

Filmsko obložena tableta

Peroralna uporaba

Češka

| 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 miligramov

Filmsko obložena tableta

Peroralna uporaba

Češka

| 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 miligramov

Filmsko obložena tableta

Peroralna uporaba

Češka

| 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 miligramov

Kapsula

Peroralna uporaba

Češka

| 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 miligramov

Kapsula

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

15 miligramov

Trda kapsula

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

25 miligramov

Trda kapsula

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

50 miligramov

Trda kapsula

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Danska

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

Janssen-Cilag A/S - DK

Hammerbakken 19, 3460 Birkerød, Danska

Topimax

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Estonija

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

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Litva

TOPAMAX 100 mg

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Estonija

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

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Litva

TOPAMAX 200 mg

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Estonija

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

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Litva

TOPAMAX 25 mg

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Estonija

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

UAB Johnson & Johnson - LT

Geležinio Vilko g. 18A

LT-08104 Vilnius

Litva

TOPAMAX 50 mg

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 15 mg kapseli, kova

15 miligramov

Trda kapsula

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 100 mg tabletti, kalvopäällysteinen

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 200 mg tabletti, kalvopäällysteinen

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 25 mg tabletti, kalvopäällysteinen

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 50 mg tabletti, kalvopäällysteinen

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 25 mg kapseli, kova

25 miligramov

Trda kapsula

Peroralna uporaba

Finska

| Janssen-Cilag OY – FI |
| --- |
| Metsänneidonkuja 8 |
| 02130 Espoo Finska |

Janssen-Cilag OY – FI

Metsänneidonkuja 8

02130 Espoo Finska

Topimax 50 mg kapseli, kova

50 miligramov

Trda kapsula

Peroralna uporaba

Francija

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

Janssen-Cilag S.A. – FR

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

EPITOMAX 100 mg, COMPRIME PELLICULE

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Francija

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

Janssen-Cilag S.A. – FR

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

EPITOMAX 200 mg, COMPRIME PELLICULE

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Francija

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

Janssen-Cilag S.A. – FR

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

EPITOMAX 50 mg, COMPRIME PELLICULE

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Francija

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

Janssen-Cilag S.A. – FR

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

EPITOMAX 15 mg, GELULE

15 miligramov

Kapsula

Peroralna uporaba

Francija

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

Janssen-Cilag S.A. – FR

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

EPITOMAX 25 mg, GELULE

25 miligramov

Kapsula

Peroralna uporaba

Francija

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

Janssen-Cilag S.A. – FR

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

EPITOMAX 50 mg, GELULE

50 miligramov

Kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Cilag 25 mg Hartkapseln

25 miligramov

Trda kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Janssen 25 mg Hartkapseln

25 miligramov

Trda kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Cilag 50 mg Hartkapseln

50 miligramov

Trda kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Janssen 50 mg Hartkapseln

50 miligramov

Trda kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topamax 100 mg Filmtabletten

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Janssen 100 mg Filmtabletten

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

TOPAMAX MIGRÄNE 100 mg Filmtabletten

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat - Cilag 100 mg Filmtabletten

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Cilag 100 mg Filmtabletten

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topamax 200 mg Filmtabletten

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

TOPAMAX MIGRÄNE 200 mg Filmtabletten

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat - Cilag 200 mg Filmtabletten

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Cilag 200 mg Filmtabletten

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Janssen 200 mg Filmtabletten

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topamax 25 mg Filmtabletten

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

TOPAMAX MIGRÄNE 25 mg Filmtabletten

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Cilag 25 mg Filmtabletten

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Janssen 25 mg Filmtabletten

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topamax 50 mg Filmtabletten

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

TOPAMAX MIGRÄNE 50 mg Filmtabletten

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Cilag 50 mg Filmtabletten

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topiramat-Janssen 50 mg Filmtabletten

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topamax 25 mg Kapseln

25 miligramov

Trda kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

TOPAMAX MIGRÄNE 25 mg Hartkapseln

25 miligramov

Kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

Topamax 50 mg Kapseln

50 miligramov

Trda kapsula

Peroralna uporaba

Nemčija

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

Janssen-Cilag GmbH - DE

Raiffeisenstr. 8

41470 Neuss, Nemčija

TOPAMAX MIGRÄNE 50 mg Hartkapseln

50 miligramov

Kapsula

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

15 miligramov

Trda kapsula

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

25 miligramov

Trda kapsula

Peroralna uporaba

Grčija

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

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

56 Eirinis Avenue 56, Pefki, 15121, Grčija

TOPAMAC

50 miligramov

Trda kapsula

Peroralna uporaba

Madžarska

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

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Madžarska

Topamax 100 mg film-coated tablet

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Madžarska

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

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Madžarska

Topamax 200 mg film-coated tablets

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Madžarska

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

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Madžarska

Topamax 25 mg film-coated tablet

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Madžarska

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

Janssen-Cilag Kft. - HU

2045 Törökbálint Tó park, Madžarska

Topamax 50 mg film-coated tablet

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 15 mg hylki, hörð

15 miligramov

Trda kapsula

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 25 mg hylki, hörð

25 miligramov

Trda kapsula

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 50 mg hylki, hörð

50 miligramov

Trda kapsula

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 100 mg filmuhúðaðar töflur

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 200 mg filmuhúðaðar töflur

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 25 mg filmuhúðaðar töflur

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Islandija

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

Janssen-Cilag AB - SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 50 mg filmuhúðaðar töflur

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX 100 mg Tablets

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX 200 mg Tablets

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX 25 mg Tablets

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX 50 mg Tablets

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX Sprinkle Capsules 15 mg.

15 miligramov

Kapsula

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX Sprinkle Capsules 25 mg.

25 miligramov

Kapsula

Peroralna uporaba

Irska

| Janssen-Cilag Limited - GB |
| --- |
| Saunderton |
| High Wycombe |
| Buckinghamshire HP14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited - GB

Saunderton

High Wycombe

Buckinghamshire HP14 4HJ

Združeno kraljestvo

TOPAMAX Sprinkle Capsules 50 mg

50 miligramov

Kapsula

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 15 mg capsule rigide, 60 capsule

15 miligramov

Trda kapsula

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 100 mg compresse rivestite con film, 60 compresse

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

EPITOMAX 100 mg compresse rivestite con film, 60 compresse

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 200 mg compresse rivestite con film, 60 compresse

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

EPITOMAX 200 mg compresse rivestite con film, 60 compresse

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 25 mg compresse rivestite con film, 60 compresse

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

EPITOMAX 25 mg compresse rivestite con film, 60 compresse

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

TOPAMAX 300 mg compresse rivestite con film, 60 compresse

300 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

EPITOMAX 300 mg compresse rivestite con film, 60 compresse

300 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 400 mg compresse rivestite con film, 60 compresse

400 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

EPITOMAX 400 mg compresse rivestite con film, 60 compresse

400 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 50 mg compresse rivestite con film, 60 compresse

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

J.C. Healthcare srl – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano,

Italija

EPITOMAX 50 mg compresse rivestite con film, 60 compresse

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 25 mg capsule rigide, 60 capsule

25 miligramov

Trda kapsula

Peroralna uporaba

Italija

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

Janssen-Cilag SpA – IT

Via Michelangelo Buonarroti n. 23

Cologno Monzese, 20093, Milano, Italija

TOPAMAX 50 mg capsule rigide, 60 capsule

50 miligramov

Trda kapsula

Peroralna uporaba

Latvija

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

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Litva

Topamax 100 mg coated tablets

100 miligramov

Obložena tableta

Peroralna uporaba

Latvija

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

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Litva

Topamax 25 mg coated tablets

25 miligramov

Obložena tableta

Peroralna uporaba

Latvija

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

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Litva

Topamax 50 mg coated tablets

50 miligramov

Obložena tableta

Peroralna uporaba

Latvija

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

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Litva

Topamax 15 mg sprinkle capsules

15 miligramov

Kapsula

Peroralna uporaba

Latvija

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

UAB Johnson & Johnson - LT

Šeimyniškių g.1A, LT-09312 Vilnius, Litva

Topamax 25 mg sprinkle capsules

25 miligramov

Kapsula

Peroralna uporaba

Litva

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

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Litva

Topamax

100 miligramov

Tableta

Peroralna uporaba

Litva

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

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Litva

Topamax

200 miligramov

Tableta

Peroralna uporaba

Litva

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

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Litva

Topamax

25 miligramov

Tableta

Peroralna uporaba

Litva

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

UAB Johnson & Johnson

Šeimyniškių g. 1A, LT-09312 Vilnius, Litva

Topamax

50 miligramov

Tableta

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax gélules 15 mg

15 miligramov

Trda kapsula

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax comprimés 100 mg

100 miligramov

Tableta

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax comprimés 200 mg

200 miligramov

Tableta

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax comprimés 25 mg

25 miligramov

Tableta

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax comprimés 50 mg

50 miligramov

Tableta

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax gélules 25 mg

25 miligramov

Trda kapsula

Peroralna uporaba

Luksemburg

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

Janssen-Cilag NV – BE

Roderveldlaan 1 2600 Berchem, Belgija

Topamax gélules 50 mg

50 miligramov

Trda kapsula

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

100 miligramov

Tableta

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

200 miligramov

Tableta

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

25 miligramov

Tableta

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

50 miligramov

Tableta

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

15 miligramov

Trda kapsula

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

25 miligramov

Trda kapsula

Peroralna uporaba

Malta

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

Janssen-Cilag International NV - BE

Turnhoutseweg 30, B-2340 Beerse, Belgija

Topamax

50 miligramov

Trda kapsula

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax omhulde tabletten 100 mg, omhulde tabletten

100 miligramov

Obložena tableta

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax omhulde tabletten 200 mg, omhulde tabletten

200 miligramov

Obložena tableta

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax omhulde tabletten 25 mg, omhulde tabletten

25 miligramov

Obložena tableta

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax omhulde tabletten 50 mg, omhulde tabletten

50 miligramov

Obložena tableta

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax Sprinkle capsules 15 mg, capsules

15 miligramov

Kapsula

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax Sprinkle capsules 25 mg, capsules

25 miligramov

Kapsula

Peroralna uporaba

Nizozemska

| Janssen-Cilag BV – NL |
| --- |
| Dr. Paul Janssenweg 150 |
| PO Box 90240 |
| 5000 LT Tilburg |
| Nizozemska |

Janssen-Cilag BV – NL

Dr. Paul Janssenweg 150

PO Box 90240

5000 LT Tilburg

Nizozemska

Topamax Sprinkle capsules 50 mg, capsules

50 miligramov

Kapsula

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 15 mg Kapsel, hard

15 miligramov

Trda kapsula

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 25 mg Kapsel, hard

25 miligramov

Trda kapsula

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 50 mg Kapsel, hard

50 miligramov

Trda kapsula

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 100 mg Tabletter filmdrasjert

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 200 mg Tabletter filmdrasjert

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 25 mg Tabletter filmdrasjert

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Norveška

| Janssen-Cilag AS – NO |
| --- |
| Hoffsveien 1D |
| 0275 Oslo Norveška |

Janssen-Cilag AS – NO

Hoffsveien 1D

0275 Oslo Norveška

Topimax 50 mg Tabletter filmdrasjert

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgija |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgija

Topamax 100 mg tabletki powlekane

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgija |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgija

Topamax 200 mg tabletki powlekane

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgija |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgija

Topamax 25 mg tabletki powlekane

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgija |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgija

Topamax 50 mg tabletki powlekane

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgija |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgija

Topamax , 15 mg kapsulki

15 miligramov

Kapsula

Peroralna uporaba

Poljska

| Janssen-Cilag International NV - BE |
| --- |
| Turnhoutseweg 30 |
| B-2340 Beerse |
| Belgija |

Janssen-Cilag International NV - BE

Turnhoutseweg 30

B-2340 Beerse

Belgija

Topamax , 25 mg kapsulki

25 miligramov

Kapsula

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

15 miligramov

Trda kapsula

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

25 miligramov

Trda kapsula

Peroralna uporaba

Portugalska

| Janssen-Cilag Farmacêutica, Lda. – PT |
| --- |
| Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska |

Janssen-Cilag Farmacêutica, Lda. – PT

Estrada Consiglieri Pedroso, 69 A - Queluz de Baixo 2734-503 Barcarena Portugalska

Topamax

50 miligramov

Trda kapsula

Peroralna uporaba

Romunija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenija |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenija

TOPAMAX 100 tablets

100 miligramov

Tableta

Peroralna uporaba

Romunija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenija |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenija

TOPAMAX 200 tablets

200 miligramov

Tableta

Peroralna uporaba

Romunija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenija |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenija

TOPAMAX 25 tablets

25 miligramov

Tableta

Peroralna uporaba

Romunija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenija |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenija

TOPAMAX 50 tablets

50 miligramov

Tableta

Peroralna uporaba

Romunija

| Johnson & Johnson, d.o.o. – SI |
| --- |
| Smartinska cesta 53, |
| Ljubljana, |
| Slovenija |

Johnson & Johnson, d.o.o. – SI

Smartinska cesta 53,

Ljubljana,

Slovenija

TOPAMAX sprinkle caps

50 miligramov

Kapsula

Peroralna uporaba

Slovaška

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovaška |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovaška

Topamax 15 mg cps

15 miligramov

Trda kapsula s podaljšanim sproščanjem

Peroralna uporaba

Slovaška

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovaška |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovaška

Topamax 25 mg cps

25 miligramov

Trda kapsula s podaljšanim sproščanjem

Peroralna uporaba

Slovaška

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovaška |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovaška

Topamax 100

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovaška

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovaška |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovaška

Topamax 200

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovaška

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovaška |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovaška

Topamax 25

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovaška

| Johnson & Johnson, s.r.o – SK |
| --- |
| Plynárenská 7/B |
| 824 78 Bratislava |
| Slovaška |

Johnson & Johnson, s.r.o – SK

Plynárenská 7/B

824 78 Bratislava

Slovaška

Topamax 50

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovenija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenija |

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

Šmartinska 53, Ljubljana, Slovenija

TOPAMAX 100 mg filmsko obložene tablete

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovenija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenija |

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

Šmartinska 53, Ljubljana, Slovenija

TOPAMAX 200 mg filmsko obložene tablete

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovenija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenija |

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

Šmartinska 53, Ljubljana, Slovenija

TOPAMAX 25 mg filmsko obložene tablete

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovenija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenija |

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

Šmartinska 53, Ljubljana, Slovenija

TOPAMAX 50 mg filmsko obložene tablete

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Slovenija

| Johnson & Johnson, Prodaja medicinskih in farmacevtskih izdelkov, d.o.o. – SI |
| --- |
| Šmartinska 53, Ljubljana, Slovenija |

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

Šmartinska 53, Ljubljana, Slovenija

TOPAMAX 15 mg kapsule

15 miligramov

Trda kapsula

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX 100 mg Comprimidos recubiertos

100 miligramov

Obložena tableta

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX 200 mg Comprimidos recubiertos

200 miligramov

Obložena tableta

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX 25 mg Comprimidos recubiertos

25 miligramov

Obložena tableta

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX 50 mg Comprimidos recubiertos

50 miligramov

Obložena tableta

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX DISPERSABLE 15 mg, cápsulas

15 miligramov

Kapsula

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX DISPERSABLE 25 mg, cápsulas

25 miligramov

Kapsula

Peroralna uporaba

Španija

| Janssen-Cilag S.A. – ES |
| --- |
| Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija |

Janssen-Cilag S.A. – ES

Paseo de las DoceEstrellas, 5-7 28042 Madrid, Španija

TOPAMAX DISPERSABLE 50 mg, cápsulas

50 miligramov

Kapsula

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 15 mg kapslar, hårda

15 miligramov

Trda kapsula

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 25 mg kapslar, hårda

25 miligramov

Trda kapsula

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 50 mg kapslar, hårda

50 miligramov

Trda kapsula

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 100 mg tabletter, filmdragerade

100 miligramov

Filmsko obložena tableta

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 200 mg tabletter, filmdragerade

200 miligramov

Filmsko obložena tableta

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 25 mg tabletter, filmdragerade

25 miligramov

Filmsko obložena tableta

Peroralna uporaba

Švedska

| Janssen-Cilag AB – SE |
| --- |
| Box 7073 192 07 Sollentuna, Švedska |

Janssen-Cilag AB – SE

Box 7073 192 07 Sollentuna, Švedska

Topimax 50 mg tabletter, filmdragerade

50 miligramov

Filmsko obložena tableta

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX 100 mg Tablets

100 miligramov

Tableta

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX 200 mg Tablets

200 miligramov

Tableta

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX 25 mg Tablets

25 miligramov

Tableta

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX 50 mg Tablets

50 miligramov

Tableta

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX Sprinkle Capsules 15 mg

15 miligramov

Kapsula

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX Sprinkle Capsules 25 mg

25 miligramov

Kapsula

Peroralna uporaba

Združeno kraljestvo

| Janssen-Cilag Limited – GB |
| --- |
| Saunderton |
| High-Wycombe |
| Buckinghamshire HP 14 4HJ |
| Združeno kraljestvo |

Janssen-Cilag Limited – GB

Saunderton

High-Wycombe

Buckinghamshire HP 14 4HJ

Združeno kraljestvo

TOPAMAX Sprinkle Capsules 50 mg

50 miligramov

Kapsula

Peroralna uporaba

---

DODATEK III

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EEA | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | Izmišljeno ime Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebina
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Bayer Austria GmbH |
| Herbststraße 6-10 |
| 1160 Wien |
| Avstrija |

Država članica EU/EEA

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebina

(koncentracija)

Avstrija

Bayer Austria GmbH

Herbststraße 6-10

1160 Wien

Avstrija

Avelox 400mg - Infusionslösung

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Belgija

| Bayer SA-NV |
| --- |
| Avenue Louise 143 Louizalaan |
| B-1050 Bruxelles-Brussel |
| Belgija |

Bayer SA-NV

Avenue Louise 143 Louizalaan

B-1050 Bruxelles-Brussel

Belgija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Ciper

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| 151 25 Marousi - Athens |
| Grčija |

Bayer Hellas S.A.

Sorou 18-20

151 25 Marousi - Athens

Grčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Češka

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox 400 mg/ 250 ml infuzní roztok

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Danska

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Estonija

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Finska

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Francija

| Bayer Santé |
| --- |
| 13, rue Jean Jaurès |
| 92807 Puteaux Cedex |
| Francija |

Bayer Santé

13, rue Jean Jaurès

92807 Puteaux Cedex

Francija

Izilox 400 mg / 250 ml, solution pour perfusion

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Nemčija

| Bayer Vital GmbH |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer Vital GmbH

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avalox 400 mg / 250 ml Infusionslösung

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Grčija

| Bayer Hellas S.A. |
| --- |
| Sorou 18-20 |
| 151 25 Marousi - Athens |
| Grčija |

Bayer Hellas S.A.

Sorou 18-20

151 25 Marousi - Athens

Grčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Madžarska

| Bayer Hungária Kft |
| --- |
| Alkotás ut.50 |
| 1123 Budapest |
| Madžarska |

Bayer Hungária Kft

Alkotás ut.50

1123 Budapest

Madžarska

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Irska

| Bayer Limited |
| --- |
| The Atrium |
| Blackthorn Road, |
| Dublin 18 |
| Irska |

Bayer Limited

The Atrium

Blackthorn Road,

Dublin 18

Irska

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Italija

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avalox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Latvija

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Litva

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Luksemburg

| Bayer SA-NV |
| --- |
| Avenue Louise 143 Louizalaan |
| B-1050 Brussel |
| Belgija |

Bayer SA-NV

Avenue Louise 143 Louizalaan

B-1050 Brussel

Belgija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Malta

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avalox 400 mg / 250 ml Solution for Infusion

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Nizozemska

| Bayer BV |
| --- |
| Energieweg 1 |
| 3641 RT Mijdrecht |
| Nizozemska |

Bayer BV

Energieweg 1

3641 RT Mijdrecht

Nizozemska

Avelox 400 mg / 250 ml oplossing voor infusie

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Poljska

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Portugalska

| BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda. |
| --- |
| Rua Quinta do Pinheiro, 5 |
| 2794-003 Carnaxide |
| Portugalska |

BayHealth - Comercialização de Produtos Farmacêuticos Unipessoal, Lda.

Rua Quinta do Pinheiro, 5

2794-003 Carnaxide

Portugalska

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Slovaška

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox 400mg / 250ml infúzny roztok

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Slovenija

| BAYER d.o.o. |
| --- |
| Bravničarjeva 13 |
| 1000 Ljubljana |
| Slovenija |

BAYER d.o.o.

Bravničarjeva 13

1000 Ljubljana

Slovenija

Avelox 400 mg / 250 ml raztopina za infundiranje

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Španija

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Muzolil

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Švedska

| Bayer HealthCare AG |
| --- |
| Kaiser Wilhelm Allee |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

Kaiser Wilhelm Allee

51368 Leverkusen

Nemčija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Velika Britanija

| Bayer plc |
| --- |
| Bayer House |
| Strawberry Hill |
| Newbury |
| Berkshire RG14 1JA |
| Velika Britanija |

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

Velika Britanija

Avelox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

---

DODATEK IV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EEA | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebina
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Bayer HealthCare AG |
| 51368 Leverkusen |
| Nemčija |

Država članica EU/EEA

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebina

(koncentracija)

Avstrija

Bayer HealthCare AG

51368 Leverkusen

Nemčija

Octegra 400 mg - Infusionslösung

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Belgija

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

51368 Leverkusen

Nemčija

Proflox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Francija

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

51368 Leverkusen

Nemčija

Octegra 400 mg / 250 ml, solution pour perfusion

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Nemčija

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

51368 Leverkusen

Nemčija

Octegra 400 mg / 250 ml Infusionslösung

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Grčija

| Elpen Pharmaceutical Co, Inc |
| --- |
| 95, Marathonos Avenue |
| 190-09 Pikermi |
| Grčija |

Elpen Pharmaceutical Co, Inc

95, Marathonos Avenue

190-09 Pikermi

Grčija

Octegra

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Luksemburg

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

51368 Leverkusen

Nemčija

Proflox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Nizozemska

| Bayer HealthCare AG |
| --- |
| 51368 Leverkusen |
| Nemčija |

Bayer HealthCare AG

51368 Leverkusen

Nemčija

Octegra 400 mg / 250 ml oplossing voor infusie

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

Portugalska

| Bialfar - Produtos Farmacêuticos S.A. |
| --- |
| À Av. da Siderurgia Nacional |
| 4745-457 S. Mamede do Coronado |
| Portugalska |

Bialfar - Produtos Farmacêuticos S.A.

À Av. da Siderurgia Nacional

4745-457 S. Mamede do Coronado

Portugalska

Proflox

400 mg

raztopina za infundiranje

intravenska uporaba

400 mg / 250 ml

---

DODATEK V

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | Izmišljeno ime Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | | Helm Pharmaceuticals GmbH |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 25 Mikrogramm/h Transdermales Pflaster

25 μg/h

transdermalni obliž

transdermalna uporaba

Avstrija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 50 Mikrogramm/h Transdermales Pflaster

50 μg/h

transdermalni obliž

transdermalna uporaba

Avstrija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 75 Mikrogramm/h Transdermales Pflaster

75 μg/h

transdermalni obliž

transdermalna uporaba

Avstrija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 100 Mikrogramm/h Transdermales Pflaster

100 μg/h

transdermalni obliž

transdermalna uporaba

Belgija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm Pharmaceuticals 25 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

25 μg/h

transdermalni obliž

transdermalna uporaba

Belgija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm Pharmaceuticals 50 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

50 μg/h

transdermalni obliž

transdermalna uporaba

Belgija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm Pharmaceuticals 75 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

75 μg/h

transdermalni obliž

transdermalna uporaba

Belgija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm Pharmaceuticals 100 μg/h Pleister voor transdermaal gebruik/Dispositif transdermique/transdermales Pflaster

100 μg/h

transdermalni obliž

transdermalna uporaba

Nemčija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 25 μ/h Transdermales Pflaster

25 μg/h

transdermalni obliž

transdermalna uporaba

Nemčija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 50 μ/h Transdermales Pflaster

50 μg/h

transdermalni obliž

transdermalna uporaba

Nemčija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 75 μ/h Transdermales Pflaster

75 μg/h

transdermalni obliž

transdermalna uporaba

Nemčija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 100 μ/h Transdermales Pflaster

100 μg/h

transdermalni obliž

transdermalna uporaba

Italija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 25 μg/h cerotto transdermico

25 μg/h

transdermalni obliž

transdermalna uporaba

Italija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 50 μg/h cerotto transdermico

50 μg/h

transdermalni obliž

transdermalna uporaba

Italija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 75 μg/h cerotto transdermico

75 μg/h

transdermalni obliž

transdermalna uporaba

Italija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanyl Helm 100 μg/h cerotto transdermico

100 μg/h

transdermalni obliž

transdermalna uporaba

Nizozemska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 25 μg/h Pleister voor transderaal gebruik

25 μg/h

transdermalni obliž

transdermalna uporaba

Nizozemska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 50 μg/h Pleister voor transderaal gebruik

50 μg/h

transdermalni obliž

transdermalna uporaba

Nizozemska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 75 μg/h Pleister voor transderaal gebruik

75 μg/h

transdermalni obliž

transdermalna uporaba

Nizozemska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentrix 100 μg/h Pleister voor transderaal gebruik

100 μg/h

transdermalni obliž

transdermalna uporaba

Portugalska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Helm

25 μg/h

transdermalni obliž

transdermalna uporaba

Portugalska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Helm

50 μg/h

transdermalni obliž

transdermalna uporaba

Portugalska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Helm

75 μg/h

transdermalni obliž

transdermalna uporaba

Portugalska

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Helm

100 μg/h

transdermalni obliž

transdermalna uporaba

Slovenije

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanil HELM 25 mikrogramov/h transdermalni obliži

25 μg/h

transdermalni obliž

transdermalna uporaba

Slovenije

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanil HELM 50 mikrogramov/h transdermalni obliži

50 μg/h

transdermalni obliž

transdermalna uporaba

Slovenije

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanil HELM 75 mikrogramov/h transdermalni obliži

75 μg/h

transdermalni obliž

transdermalna uporaba

Slovenije

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanil HELM 100 mikrogramov/h transdermalni obliži

100 μg/h

transdermalni obliž

transdermalna uporaba

Španija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Matrix Helm 25 microgramos/hora parches transdérmicos EFG

25 μg/h

transdermalni obliž

transdermalna uporaba

Španija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Matrix Helm 50 microgramos/hora parches transdérmicos EFG

50 μg/h

transdermalni obliž

transdermalna uporaba

Španija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Matrix Helm 75 microgramos/hora parches transdérmicos EFG

75 μg/h

transdermalni obliž

transdermalna uporaba

Španija

| Helm Pharmaceuticals GmbH |
| --- |
| Nordkanalstrasse 28 |
| 20097 Hamburg |
| Nemčija |

Helm Pharmaceuticals GmbH

Nordkanalstrasse 28

20097 Hamburg

Nemčija

Fentanilo Matrix Helm 100 microgramos/hora parches transdérmicos EFG

100 μg/h

transdermalni obliž

transdermalna uporaba

---

DODATEK VI

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebina
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | AstraZeneca Österreich GmbH, |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Avstrija |

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebina

(koncentracija)

Avstrija

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7

A-1037 Wien

Avstrija

Optinem i.v. 500 mg - Trockenstechampullen

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Avstrija

| AstraZeneca Österreich GmbH, |
| --- |
| Schwarzenbergplatz 7 |
| A-1037 Wien |
| Avstrija |

AstraZeneca Österreich GmbH,

Schwarzenbergplatz 7

A-1037 Wien

Avstrija

Optinem i.v. 1 g - Trockenstechampullen

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g /30 ml

Belgija

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Belgija |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel

Belgija

Meronem IV 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Belgija

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel |
| Belgija |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel

Belgija

Meronem IV 1 g

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Bolgarija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton Bedfordshire LU1 3LU

Velika Britanija

Meronem

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Bolgarija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton Bedfordshire LU1 3LU

Velika Britanija

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Ciper

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

MERONEM

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Ciper

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

MERONEM

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Češka republika

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

MERONEM

500 mg

Prašek za raztopino za injiciranje

Intravenska uporaba

500 mg/20 ml

Češka republika

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

MERONEM

1 g

Prašek za raztopino za injiciranje

Intravenska uporaba

1 g/30 ml

Danska

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Danska |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Danska

MERONEM

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Danska

| AstraZeneca A/S |
| --- |
| Roskildevej 22 |
| 2620 Albertslund |
| Danska |

AstraZeneca A/S

Roskildevej 22

2620 Albertslund

Danska

MERONEM

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Estonija

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Velika Britanija |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Velika Britanija

Meronem

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/10 ml

Estonija

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Velika Britanija |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Velika Britanija

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/20 ml

Finska

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finska |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finska

Meronem 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Finska

| AstraZeneca Oy |
| --- |
| Luomanportti 3 |
| FI-02200 Espoo |
| Finska |

AstraZeneca Oy

Luomanportti 3

FI-02200 Espoo

Finska

Meronem 1 g

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Francija

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON Cédex |
| Francija |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cédex

Francija

MERONEM

500 mg poudre pour solution injectable IV

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Francija

| AstraZeneca |
| --- |
| 1, Place Renault |
| 92844 RUEIL-MALMAISON Cédex |
| Francija |

AstraZeneca

1, Place Renault

92844 RUEIL-MALMAISON Cédex

Francija

MERONEM

1 g poudre pour solution injectable IV

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Nemčija

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postal 22876 Wedel |
| Nemčija |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postal 22876 Wedel

Nemčija

Meronem 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/10 ml

5 mg/ml

Nemčija

| AstraZeneca GmbH |
| --- |
| Tinsdaler Weg 183 |
| 22880 Wedel |
| Postal 22876 Wedel |
| Nemčija |

AstraZeneca GmbH

Tinsdaler Weg 183

22880 Wedel

Postal 22876 Wedel

Nemčija

Meronem 1000 mg

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/20 ml

5 mg/ml

Grčija

| CANA Pharmaceutical Laboratories Societe Anonyme |
| --- |
| 446 Irakliou Ave. |
| GR-141 22 Iraklion Attikis, |
| Grčija |

CANA Pharmaceutical Laboratories Societe Anonyme

446 Irakliou Ave.

GR-141 22 Iraklion Attikis,

Grčija

Meronem

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Grčija

| CANA Pharmaceutical Laboratories Societe Anonyme |
| --- |
| 446 Irakliou Ave |
| GR-141 22 Iraklion Attikis, |
| Grčija |

CANA Pharmaceutical Laboratories Societe Anonyme

446 Irakliou Ave

GR-141 22 Iraklion Attikis,

Grčija

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Madžarska

| AstraZeneca Kft.- Hungary |
| --- |
| H-2045 Törökbálint |
| Park u. 3. |
| Madžarska |

AstraZeneca Kft.- Hungary

H-2045 Törökbálint

Park u. 3.

Madžarska

Meronem 500 mg intravenas injekcio

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Madžarska

| AstraZeneca Kft. - Hungary |
| --- |
| H-2045 Törökbálint |
| Park u. 3. |
| Madžarska |

AstraZeneca Kft. - Hungary

H-2045 Törökbálint

Park u. 3.

Madžarska

Meronem 1g intravenas injekcio

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Islandija

| AstraZeneca UK Ltd. |
| --- |
| Alderley Park |
| Macclesfield |
| Cheshire SK10 4TF |
| Velika Britanija |

AstraZeneca UK Ltd.

Alderley Park

Macclesfield

Cheshire SK10 4TF

Velika Britanija

Meronem 500 mg stungulyfs-/ innrennslisstofn, lausn.

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Islandija

| AstraZeneca UK Ltd. |
| --- |
| Alderley Park |
| Macclesfield |
| Cheshire SK10 4TF |
| Velika Britanija |

AstraZeneca UK Ltd.

Alderley Park

Macclesfield

Cheshire SK10 4TF

Velika Britanija

Meronem 1 g stungulyfs-/innrennslisstofn, lausn.

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Irska

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Velika Britanija

Meronem IV 0,5 g powder for solution for injection or infusion.

0,5 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Irska

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Velika Britanija

Meronem IV 1 g powder for solution for injection or infusion.

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 500 mg polvere per soluzione iniettabile per uso endovenoso

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 1000 mg polvere per soluzione iniettabile per uso endovenoso

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 500 mg polvere e solvente per soluzione iniettabile per uso intramuscolare

500 mg

Prašek in topilo za raztopino za injiciranje

Intramuskularna uporaba

500 mg/2 ml

(se ne trži)

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 250 mg polvere e solvente per soluzione iniettabile per uso endovenoso

250 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

250 mg/5 ml

(se ne trži)

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 500 mg polvere e solvente per soluzione iniettabile per uso endovenoso

500 mg

Prašek in topilo za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/10 ml

(se ne trži)

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 1000 mg polvere e solvente per soluzione iniettabile per uso endovenoso

1 g

Prašek in topilo za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/20 ml

(se ne trži)

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 250 mg polvere e solvente per soluzione per infusione

250 mg

Prašek in topilo za raztopino za infundiranje

Intravenska uporaba

250 mg/100 ml

(se ne trži)

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 500 mg polvere e solvente per soluzione per infusione

500 mg

Prašek in topilo za raztopino za infundiranje

Intravenska uporaba

500 mg/100 ml

(se ne trži)

Italija

| AstraZeneca S.p.A. |
| --- |
| Palazzo Volta |
| Via Francesco Sforza |
| 20080 Basiglio (Milano) |
| Italija |

AstraZeneca S.p.A.

Palazzo Volta

Via Francesco Sforza

20080 Basiglio (Milano)

Italija

MERREM 1000 mg polvere e solvente per soluzione per infusione

1 g

Prašek in topilo za raztopino za infundiranje

Intravenska uporaba

1 g/100 ml

(se ne trži)

Latvija

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Latvija

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem 1 g

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Litva

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem IV

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/10 ml

Litva

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem IV

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/20 ml

Luksemburg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel, |
| Belgija |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel,

Belgija

Meronem IV 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Luksemburg

| NV AstraZeneca SA |
| --- |
| Egide Van Ophemstraat 110 |
| 1180 Brussel, |
| Belgija |

NV AstraZeneca SA

Egide Van Ophemstraat 110

1180 Brussel,

Belgija

Meronem IV 1 g

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem IV 0,5 g powder for solution for injection or infusion.

0,5 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Malta

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem IV 1 g powder for solution for injection or infusion.

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, Nizozemska |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE, Zoetermeer, Nizozemska

Meronem i.v.

250 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

V procesu ukinitve

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, Nizozemska |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE, Zoetermeer, Nizozemska

Meronem i.v.

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Nizozemska

| AstraZeneca BV |
| --- |
| Louis Pasteurlaan 5 |
| 2719 EE, Zoetermeer, Nizozemska |

AstraZeneca BV

Louis Pasteurlaan 5

2719 EE, Zoetermeer, Nizozemska

Meronem i.v.

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Norveška

| AstraZeneca AS |
| --- |
| Hoffsveien 70 |
| B/Postboks 200 |
| Vinderen |
| 0319 OSLO |
| Norveška |

AstraZeneca AS

Hoffsveien 70

B/Postboks 200

Vinderen

0319 OSLO

Norveška

Meronem

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Norveška

| AstraZeneca AS |
| --- |
| Hoffsveien 70 |
| B/Postboks 200 |
| Vinderen |
| 0319 OSLO |
| Norveška |

AstraZeneca AS

Hoffsveien 70

B/Postboks 200

Vinderen

0319 OSLO

Norveška

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Poljska

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Poljska

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Portugalska

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Valejas |
| 2745-663 Barcarena, Portugalska |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena, Portugalska

Meronem

500 mg

Prašek za raztopino za injiciranje

Intramuskularna uporaba

500 mg/2 ml

(se ne trži)

Portugalska

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Valejas |
| 2745-663 Barcarena, Portugalska |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena, Portugalska

Meronem

500 mg

Prašek za raztopino za infundiranje

Intravenska uporaba

500 mg/20 ml

Portugalska

| AstraZeneca Produtos Farmacêuticos, Lda. |
| --- |
| Rua Humberto Madeira, n.o 7, Valejas |
| 2745-663 Barcarena, Portugalska |

AstraZeneca Produtos Farmacêuticos, Lda.

Rua Humberto Madeira, n.o 7, Valejas

2745-663 Barcarena, Portugalska

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Romunija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Velika Britanija

Meronem i.v. 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Romunija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Velika Britanija

Meronem i.v. 1 g

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Slovaška republika

| AstraZeneca UK Ltd. |
| --- |
| Silk Road Business Park 1 |
| Macclesfield |
| Cheshire SK10 2NA |
| Velika Britanija |

AstraZeneca UK Ltd.

Silk Road Business Park 1

Macclesfield

Cheshire SK10 2NA

Velika Britanija

Meronem 500 mg i.v.

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Slovenija

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Velika Britanija |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Velika Britanija

Meronem 500 mg prašek za raztopino za injiciranje ali infundiranje

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg

Slovenija

| AstraZeneca UK Limited |
| --- |
| 15 Stanhope Gate |
| London WLK 1LN |
| Velika Britanija |

AstraZeneca UK Limited

15 Stanhope Gate

London WLK 1LN

Velika Britanija

Meronem 1 g prašek za raztopino za injiciranje ali infundiranje

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g

Španija

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache |
| 56 Edificio Roble |
| 28033 Madrid |
| Španija |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache

56 Edificio Roble

28033 Madrid

Španija

Meronem I.V., 500

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Španija

| AstraZeneca Farmacéutica Spain, S.A. |
| --- |
| C/ Serrano Galvache |
| 56 Edificio Roble |
| 28033 Madrid |
| Španija |

AstraZeneca Farmacéutica Spain, S.A.

C/ Serrano Galvache

56 Edificio Roble

28033 Madrid

Španija

Meronem I.V., 1 000

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

Švedska

| AstraZeneca AB |
| --- |
| S-15185 Södertälje |
| Švedska |

AstraZeneca AB

S-15185 Södertälje

Švedska

Meronem

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/10 ml

za injiciranje ali različne koncentracije za infuzijo

Švedska

| AstraZeneca AB |
| --- |
| S-15185 Södertälje |
| Švedska |

AstraZeneca AB

S-15185 Södertälje

Švedska

Meronem

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/20 ml

za injiciranje ali različne koncentracije za infuzijo

Velika Britanija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Velika Britanija

Meronem IV 500 mg

500 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg/20 ml

Velika Britanija

| AstraZeneca UK Limited |
| --- |
| 600 Capability Green |
| Luton |
| Bedfordshire LU1 3LU |
| Velika Britanija |

AstraZeneca UK Limited

600 Capability Green

Luton

Bedfordshire LU1 3LU

Velika Britanija

Meronem IV 1 g

1 g

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 g/30 ml

---

DODATEK VII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet | Izmišljeno ime | Farmacevtska oblika | Jakost | Živalska vrsta | Pot uporabe |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Avstrija |

Država članica

Imetnik dovoljenja za promet

Izmišljeno ime

Farmacevtska oblika

Jakost

Živalska vrsta

Pot uporabe

Avstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

Avstrija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Belgija

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Ciper

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC

peroralna raztopina

tilmikozin

250 mg/ml

kokoši

prašiči

peroralno

Češka republika

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC sol. ad us. vet.

peroralna raztopina

tilmikozin

250 mg/ml

kokoši (vzreja za zakol)

prašiči

teleta

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

govedo (teleta)

prašiči za pitanje

kokoši

peroralno

Grčija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Španija

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Španija |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Španija

PULMOTIL AC

peroralna raztopina

tilmikozin 250 mg/ml

prašiči

perutnina (razen kokoši nesnic)

purani

govedo

peroralno

Francija

| Lilly France SA |
| --- |
| Départament Elanco Santé Animale |
| 13 Rue Pagès |
| 92158 Suresnes Cedex |
| Francija |

Lilly France SA

Départament Elanco Santé Animale

13 Rue Pagès

92158 Suresnes Cedex

Francija

PULMOTIL AC

peroralna raztopina

tilmikozin 250 mg/ml

prašiči

teleta

kokoši

purani

peroralno

Madžarska

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC oral solution

peroralna raztopina

tilmikozin 250 mg/ml

govedo (teleta)

prašiči

kokoši

purani

peroralno

Irska

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

peroralno

Združeno kraljestvo

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

peroralno

Italija

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italija |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Luksemburg

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Nizozemska

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nizozemska |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

Nizozemska

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Portugalska

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugalska |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugalska

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

purani

prašiči

teleta

peroralno

Poljska

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

prašiči

teleta

peroralno

Slovaška republika

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

kokoši

prašiči

teleta

peroralno

Romunija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil AC

peroralna raztopina

tilmikozin 250 mg/ml

prašiči

kokoši (vzreja za zakol)

teleta

peroralno

---

DODATEK VIII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

40 g tilmikozina na 1 000 g

| Država članica | Imetnik dovoljenja za promet | Izmišljeno ime | Farmacevtska oblika | Jakost | Živalska vrsta | Pot uporabe |
| --- | --- | --- | --- | --- | --- | --- |
| Belgija | Eli Lilly Benelux N.V. |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Država članica

Imetnik dovoljenja za promet

Izmišljeno ime

Farmacevtska oblika

Jakost

Živalska vrsta

Pot uporabe

Belgija

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgija

Pulmotil 40 VET Premix

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil G 40 AMV

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil G 40 Granulat

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Danska

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Danska |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Danska

Pulmotil Vet

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Španija

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Španija |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Španija

PULMOTIL 40

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Francija

| Lilly France SA |
| --- |
| Départament Elanco Santé Animale |
| 13 Rue Pagès |
| 92158 Suresnes Cedex |
| Francija |

Lilly France SA

Départament Elanco Santé Animale

13 Rue Pagès

92158 Suresnes Cedex

Francija

Pulmotil Tilmicosine 40 Porcins

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Irska

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil G40 Premix

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Nizozemska

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nizozemska |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

Nizozemska

Pulmotil G40 premix

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

Portugalska

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugalska |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugalska

PULMOTIL G40 Pré Mistura para alimento medicamentoso

predmešanica za zdravilno krmno mešanico

40 g tilmikozina na 1 000 g

prašiči

peroralno

100 g tilmikozina na 1 000 g

| Država članica | Imetnik dovoljenja za promet | Izmišljeno ime | Farmacevtska oblika | Jakost | Živalska vrsta | Pot uporabe |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Austria |

Država članica

Imetnik dovoljenja za promet

Izmišljeno ime

Farmacevtska oblika

Jakost

Živalska vrsta

Pot uporabe

Avstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

Austria

PULMOTIL Prämix 10 % - Granulat für Schweine

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Belgija

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgija

Pulmotil 100 VET Premix

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Belgija

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52-Bte |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52-Bte

Stoofstraat 52

1000 Brussel

Belgija

Pulmotil 100 Granules

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil G 100 AMV

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil G 100

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Danska

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Danska |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Danska

Pulmotil Vet

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Danska

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Danska |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Danska

Pulmotil Vet Oralt pulver

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Španija

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Španija |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Španija

PULMOTIL 100

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Irska

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil G100 Premix

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Italija

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italija |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italija

PULMOTIL G100 PREMIX

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Luksemburg

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgija

Pulmotil 100 Vet Premix

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Nizozemska

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nizozemska |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

Nizozemska

Pulmotil G100 premix

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Portugalska

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugalska |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugalska

PULMOTIL G100 Pré Mistura para alimento medicamentoso

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

Združeno kraljestvo

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil G100 Premix

predmešanica za zdravilno krmno mešanico

100 g tilmikozina na 1 000 g

prašiči

peroralno

200 g tilmikozina na 1 000 g

| Država članica | Imetnik dovoljenja za promet | Izmišljeno ime | Farmacevtska oblika | Jakost | Živalska vrsta | Pot uporabe |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Richter Pharma AG |
| Feldgasse 19 |
| 4600 Wels |
| Avstrija |

Država članica

Imetnik dovoljenja za promet

Izmišljeno ime

Farmacevtska oblika

Jakost

Živalska vrsta

Pot uporabe

Avstrija

Richter Pharma AG

Feldgasse 19

4600 Wels

Avstrija

Pulmotil Prämix 20 %

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči, kunci

peroralno

Belgija

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue de l’Etuve 52 |
| Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue de l’Etuve 52

Stoofstraat 52

1000 Brussel

Belgija

Pulmotil 200 VET Premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči, kunci

peroralno

Češka republika

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

PULMOTIL 200 prm. ad us. vet.

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Ciper

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil G200

Premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil G 20 % AMV

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Nemčija

| Lilly Deutschland GmbH |
| --- |
| Teichweg 3 |
| 35396 Gießen |
| Nemčija |

Lilly Deutschland GmbH

Teichweg 3

35396 Gießen

Nemčija

Pulmotil G 20 %

predmešanica za zdravilno krmno mešanico

200 g tilmicosin per 1 000 g

prašiči

peroralno

Danska

| Eli Lilly Danmark A/S |
| --- |
| Elanco Animal Health |
| Nybrovej 110 |
| 2800 Lyngby |
| Danska |

Eli Lilly Danmark A/S

Elanco Animal Health

Nybrovej 110

2800 Lyngby

Danska

Pulmotil Vet

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Grčija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil 200 medicated premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Španija

| Elanco Valquímica, S.A. |
| --- |
| Avenida de la Industría, 30 |
| 28108 – Alcobendas |
| Madrid |
| Španija |

Elanco Valquímica, S.A.

Avenida de la Industría, 30

28108 – Alcobendas

Madrid

Španija

PULMOTIL 200

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Madžarska

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil G 200 premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Irska

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil G200 Premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Italija

| Eli Lilly Italia |
| --- |
| Elanco Animal Health |
| Via A. Gramsci, 731-733 |
| 50019 Sesto Fiorentino |
| Florence |
| Italija |

Eli Lilly Italia

Elanco Animal Health

Via A. Gramsci, 731-733

50019 Sesto Fiorentino

Florence

Italija

PULMOTIL G200 PREMIX

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči, kunci

peroralno

Latvija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil 200 premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Luksemburg

| Eli Lilly Benelux N.V. |
| --- |
| Elanco Animal Health |
| Rue del’Etuve 52-Bte |
| 1Stoofstraat 52 |
| 1000 Brussel |
| Belgija |

Eli Lilly Benelux N.V.

Elanco Animal Health

Rue del’Etuve 52-Bte

1Stoofstraat 52

1000 Brussel

Belgija

Pulmotil 200 Vet Premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči, kunci

peroralno

Nizozemska

| Eli Lilly Nederland B.V. |
| --- |
| Elanco Animal Health |
| Grootslag 1-5 |
| 3991 RA Houten |
| Nizozemska |

Eli Lilly Nederland B.V.

Elanco Animal Health

Grootslag 1-5

3991 RA Houten

Nizozemska

Pulmotil G200 premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Poljska

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmontil 200

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Portugalska

| Lilly Portugal - Produtos Farmacêuticos, Lda |
| --- |
| Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque, |
| Miraflores 1495-016 Algés |
| Portugalska |

Lilly Portugal - Produtos Farmacêuticos, Lda

Rua Dr. António Loureiro Borges, 1-piso 1, Arquiparque,

Miraflores 1495-016 Algés

Portugalska

PULMOTIL G200 Pré Mistura para alimento medicamentoso

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Romunija

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

Pulmotil 200 Vet Premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

Slovaška republika

| Eli Lilly Regional Operation Ges.m.b.H. |
| --- |
| Elanco Animal Health |
| Kölblgasse 8-10 |
| 1030 Vienna |
| Avstrija |

Eli Lilly Regional Operation Ges.m.b.H.

Elanco Animal Health

Kölblgasse 8-10

1030 Vienna

Avstrija

PULMOTIL G 200

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči pitanci

peroralno

Združeno kraljestvo

| Elanco Animal Health |
| --- |
| Eli Lilly and Company Ltd |
| Priestley Road |
| Basingstoke |
| Hampshire |
| RG24 9NL |
| Združeno kraljestvo |

Elanco Animal Health

Eli Lilly and Company Ltd

Priestley Road

Basingstoke

Hampshire

RG24 9NL

Združeno kraljestvo

Pulmotil G200 Premix

predmešanica za zdravilno krmno mešanico

200 g tilmikozina na 1 000 g

prašiči

peroralno

---

DODATEK IX

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE ZDRAVILA IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Predlagatelj | Izmišljeno ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Tabletten | 100 mg | Tableta | Peroralna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Granulat | 100 mg | Zrnca za peroralno suspenzijo | Peroralna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 100 mg - Suppositorien | 100 mg | Svečka | rektalna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Aulin 200 mg - Suppositorien | 200 mg | Svečka | rektalna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Tabletten | 100 mg | Tableta | Peroralna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Granulat | 100 mg | Zrnca za peroralno suspenzijo | Peroralna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 100 mg - Suppositirien | 100 mg | Svečka | rektalna uporaba |
| Avstrija | CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna | Mesulid 200 mg - Suppositorien | 200 mg | Svečka | rektalna uporaba |
| Belgija | THERABEL PHARMA S.A., |
| Rue E.Van Ophem, 108 B-1180 Uccle |

Država članica

Predlagatelj

Izmišljeno ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Tabletten

100 mg

Tableta

Peroralna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Granulat

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 100 mg - Suppositorien

100 mg

Svečka

rektalna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Aulin 200 mg - Suppositorien

200 mg

Svečka

rektalna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Tabletten

100 mg

Tableta

Peroralna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Granulat

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 100 mg - Suppositirien

100 mg

Svečka

rektalna uporaba

Avstrija

CSC Pharmaceuticals Handels GmbH, Heiligenstädter Str. 395 b, A-1190 Vienna

Mesulid 200 mg - Suppositorien

200 mg

Svečka

rektalna uporaba

Belgija

THERABEL PHARMA S.A.,

Rue E.Van Ophem, 108 B-1180 Uccle

AULIN 100 mg

100 mg

Tableta

Peroralna uporaba

Belgija

| 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

Zrnca za peroralno suspenzijo

Peroralna uporaba

Belgija

| 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

Zrnca za peroralno suspenzijo

Peroralna uporaba

Belgija

| 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

Tableta

Peroralna uporaba

Bolgarija

Tchaika Pharma Sofia 1172 1, G. M. Dimitrov Blvd.

AllGone

100 mg

Šumeča tableta

Peroralna uporaba

Bolgarija

Sopharma Sofia 1220 16, Iliensko shosse

Ameolin

100 mg

Tableta

Peroralna uporaba

Bolgarija

CSC Pharmaceuticals Sofia 1592 10, Assen Jordanov street

100 mg

Tableta.

Peroralna uporaba

Bolgarija

CSC Pharmaceuticals Sofia 1592 10, Assen Jordanov street

Aulin 100

100 mg

Zrnca

Peroralna uporaba

Bolgarija

Inbioteh Sofia 1000 5, Triaditza street ‘Sofia palace’

Biolin

100 mg

Tableta

Peroralna uporaba

Bolgarija

ZentivaSofia 1407 25, N.Vaptzarov Blvd.

Coxtral

100 mg

Tableta

Peroralna uporaba

Bolgarija

Actavis Sofia 1000 2, Kniaginia Maria Luisa Blvd.

Enetra

100 mg

Tableta

Peroralna uporaba

Bolgarija

Medochemie Sofia 1113 20, Fr. Jolio Currie street

Aponil

100 mg

Tableta

Peroralna uporaba

Bolgarija

CSC Pharmaceuticals Sofia 1592 10, Assen Jordanov street

Nimed

100 mg

Tableta

Peroralna uporaba

Bolgarija

LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, Italija

Nimesil

100 mg

Zrnca

Peroralna uporaba

CZ - Češka

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Češka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Češka

AULIN

100 mg

Zrnca za peroralno raztopino

Peroralna uporaba

CZ - Češka

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Češka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Češka

AULIN

100 mg

Tableta

Peroralna uporaba

CZ - Češka

| ZENTIVA, a.s. |
| --- |
| Empiria Palace |
| Na strži 63 |
| 140 62 Praha 4, Češka |

ZENTIVA, a.s.

Empiria Palace

Na strži 63

140 62 Praha 4, Češka

COXTRAL 100 mg TABLETY

100 mg

Tableta

Peroralna uporaba

CZ - Češka

CSC Pharmaceuticals Handels GmbH Gewerbestrasse 18-20 A-2102 Bisamberg, Avstrija

MESULID

100 mg

Zrnca za peroralno raztopino

Peroralna uporaba

CZ - Češka

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Češka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Češka

NIMED

100 mg

Tableta

Peroralna uporaba

CZ - Češka

| LABORATORI GUIDOTTI S.p.A., Via Livornese 897, |
| --- |
| I - 56010 La Vettola, PISA, Italija |

LABORATORI GUIDOTTI S.p.A., Via Livornese 897,

I - 56010 La Vettola, PISA, Italija

NIMESIL

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Ciper

MEDOCHEMIE LTD, POBOX 51409, 3505 LEMESOS, CIPER

APONIL

100 mg

TABLETA

PERORALNA UPORABA

Ciper

CDL PHARMACEUTICAL LTD, POBOX 40981, 6308 LARNACA, CIPER

ELINAP

100 mg

TABLETA

PERORALNA UPORABA

Ciper

CHR. K. UNIMED LTD, 21 DAVLOU, PLATI, 2114 AGLANTZIA, LEFKOSIA, CIPER

FLOGOSTOP

100 mg

TABLETA

PERORALNA UPORABA

Ciper

P T HADJIGEORGIOU CO LTD, POBOX 53158, 3301 LEMESOS, CIPER

NIMELIDE

100 mg

TABLETA

PERORALNA UPORABA

Ciper

CODAL SYNTO LTD, POBOX 51785, 3508 LEMESOS, CIPER

NIMM

100 mg

TABLETA

PERORALNA UPORABA

Ciper

THE STAR MEDICINES IMPORTERS & CO LTD, POBOX 50151, 3601 LEMESOS, CIPER

RITAMINE

100 mg

TABLETA

PERORALNA UPORABA

Ciper

COSMED HOLDINGS LTD, P.O.BOX 42145, 6531 LARNACA, CIPER

SPECILID

100 mg

TABLETA

PERORALNA UPORABA

Estonija

| 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

Tableta

Peroralna uporaba

Francija

| THERABEL LUCIEN PHARMA |
| --- |
| 123 rue Jules Guesde |
| 92309 LEVALLOIS-PERRET Cedex |
| Francija |

THERABEL LUCIEN PHARMA

123 rue Jules Guesde

92309 LEVALLOIS-PERRET Cedex

Francija

NEXEN

100 mg

Tableta

Peroralna uporaba

Francija

| THERABEL LUCIEN PHARMA |
| --- |
| 123 rue Jules Guesde |
| 92309 LEVALLOIS-PERRET Cedex |
| Francija |

THERABEL LUCIEN PHARMA

123 rue Jules Guesde

92309 LEVALLOIS-PERRET Cedex

Francija

NEXEN

100 mg

Zrnca za peroralno raztopino

Peroralna uporaba

Francija

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| DUBLIN 15 |
| IRSKA |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

DUBLIN 15

IRSKA

OXETIAN

100 mg

Tableta

Peroralna uporaba

Francija

| HELSINN BIREX PHARMACEUTICALS Ltd |
| --- |
| Damastown Mulhuddart |
| DUBLIN 15 |
| IRSKA |

HELSINN BIREX PHARMACEUTICALS Ltd

Damastown Mulhuddart

DUBLIN 15

IRSKA

OXETIAN

100 mg

Zrnca za peroralno raztopino

Peroralna uporaba

Grčija

| 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

TABLETA

PERORALNA UPORABA

Grčija

| 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

SVEČKA

REKTALNA UPORABA

Grčija

| 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

ZRNCA ZA PERORALNO RAZTOPINO

PERORALNA UPORABA

Grčija

| FARMEDIA A.E. |
| --- |
| ATHINAS 22 & APOLLONOS |
| GERAKAS, ATTIKIS, 15344 |

FARMEDIA A.E.

ATHINAS 22 & APOLLONOS

GERAKAS, ATTIKIS, 15344

MULTIFORMIL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| PHARMATHEN INTERNATIONAL S.A. GRČIJA, |
| --- |
| DERVENAKIWN 4, PALLINI, ATTIKIS 15351 |

PHARMATHEN INTERNATIONAL S.A. GRČIJA,

DERVENAKIWN 4, PALLINI, ATTIKIS 15351

BIOXIDOL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| ALET PHARMACEUTICALS |
| --- |
| M. ALEXANDER 121, AGIA VARVARA, 12351 |

ALET PHARMACEUTICALS

M. ALEXANDER 121, AGIA VARVARA, 12351

SPECILID

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| BIOSPRAY ABEE |
| --- |
| 18TH Km MARATHONOS AVENUE, PALLINI, 15344 |

BIOSPRAY ABEE

18TH Km MARATHONOS AVENUE, PALLINI, 15344

FLOGOSTOP

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| BIOMEDICA-CHEMICA A.E. |
| --- |
| G. LYRA 25, KATW KIFISSIA |

BIOMEDICA-CHEMICA A.E.

G. LYRA 25, KATW KIFISSIA

NIMESULIDE/BIOMEDICA CHEMICA

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| LEOVAN, M. LEWN & SIA EE |
| --- |
| ARGONAFTWN 22, ARGYROUPOLI, 16452 |

LEOVAN, M. LEWN & SIA EE

ARGONAFTWN 22, ARGYROUPOLI, 16452

RISTOLZIT

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| NORMA HELLAS A.E. |
| --- |
| MENANDROU 54, ATHENS, 10431 |

NORMA HELLAS A.E.

MENANDROU 54, ATHENS, 10431

MYXINA

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| GENEPHARM A.E. |
| --- |
| 18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351 |

GENEPHARM A.E.

18TH Km MARATHONOS AVENUE, PALLINI, ATTIKIS, 15351

NIMELIDE

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| BROS EPE |
| --- |
| AVGIS & GALLINIS 15, N. KIFISSIA |

BROS EPE

AVGIS & GALLINIS 15, N. KIFISSIA

DISCORID

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| RAFARM AEBE |
| --- |
| KORINTHOU 12, N. PSYCHIKO, 15451 |

RAFARM AEBE

KORINTHOU 12, N. PSYCHIKO, 15451

VENTOR

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| RAFARM AEBE |
| --- |
| KORINTHOU 12, N. PSYCHIKO, 15451 |

RAFARM AEBE

KORINTHOU 12, N. PSYCHIKO, 15451

VENTOR

100 mg

ZRNCA ZA PERORALNO RAZTOPINO

PERORALNA UPORABA

Grčija

| ARMEDICA A.E. |
| --- |
| AGIAS MARKELLIS 17, ATHENS, 11855 |

ARMEDICA A.E.

AGIAS MARKELLIS 17, ATHENS, 11855

ALENCAST

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| GAP A.E. |
| --- |
| AGISILAOU 46, AGIOS DIMITRIOS, 17341 |

GAP A.E.

AGISILAOU 46, AGIOS DIMITRIOS, 17341

G-REVM

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| VIOFAR EPE |
| --- |
| ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671 |

VIOFAR EPE

ETHNIKIS ANTISTASEOS & TRIFYLLIAS, AHARNAI, 13671

VOLONTEN

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| KLEVA EPE |
| --- |
| PARNITHOS AVENUE 189, |
| AHARNAI, ATTIKIS, 13671 |

KLEVA EPE

PARNITHOS AVENUE 189,

AHARNAI, ATTIKIS, 13671

ELINAP

100 mg

Prašek za peroralno raztopino

PERORALNA UPORABA

Grčija

| KLEVA EPE |
| --- |
| PARNITHOS AVENUE 189, |
| AHARNAI, ATTIKIS, 13671 |

KLEVA EPE

PARNITHOS AVENUE 189,

AHARNAI, ATTIKIS, 13671

ELINAP

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| MINERVA PHARMAKEFTIKI A.E. |
| --- |
| KIFISSOU AVENUE 132, PERISTERI, 12131 |

MINERVA PHARMAKEFTIKI A.E.

KIFISSOU AVENUE 132, PERISTERI, 12131

MIN-A-PON

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| ANFARM HELLAS A.E. |
| --- |
| K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232 |

ANFARM HELLAS A.E.

K. PALEOLOGOU & PERIKLEOUS 27, HALANDRI, 15232

LEMESIL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| MARATHONOS AVENUE 95, PIKERMI, 19009 |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

MARATHONOS AVENUE 95, PIKERMI, 19009

ROLAKET

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| ELPEN A.E. PHARMACEUTICAL INDUSTRY, |
| --- |
| MARATHONOS AVENUE 95, PIKERMI, 19009 |

ELPEN A.E. PHARMACEUTICAL INDUSTRY,

MARATHONOS AVENUE 95, PIKERMI, 19009

ROLAKET

200 mg

SVEČKA

REKTALNA UPORABA

Grčija

| ANTOR EPE |
| --- |
| P. MAVROMIHALI 1, VRILISSIA, 15235 |

ANTOR EPE

P. MAVROMIHALI 1, VRILISSIA, 15235

MELIMONT

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| HELP ABEE |
| --- |
| VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452 |

HELP ABEE

VALAORITOU 10, METAMORFOSI, ATTIKIS, 14452

MOSUOLIT

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| FINIXFARM EPE |
| --- |
| DERVENAKION 38 & SAHINI, GERAKAS, 15344 |

FINIXFARM EPE

DERVENAKION 38 & SAHINI, GERAKAS, 15344

KARTAL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| 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

TABLETA

PERORALNA UPORABA

Grčija

| REMEK PHARMACEUTICALS ABEE |
| --- |
| PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564 |

REMEK PHARMACEUTICALS ABEE

PENTELIS 34, PALAIO FALIRO, ATTIKIS, 17564

MESUPON

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| FARMANIC CHEMIPHARMA S.A. |
| --- |
| FYLIS 137, KAMATERO, ATTIKIS, 13451 |

FARMANIC CHEMIPHARMA S.A.

FYLIS 137, KAMATERO, ATTIKIS, 13451

CHEMISULIDE

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| REMEDINA ABEE |
| --- |
| GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451 |

REMEDINA ABEE

GOUNARI 25 & AREOS, KAMATERO, ATTIKIS, 13451

AMOCETIN

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| COSMOPHARM EPE |
| --- |
| P.O. BOX 42, KORINTHOS, 20100 |

COSMOPHARM EPE

P.O. BOX 42, KORINTHOS, 20100

LIZEPAT

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| DEMO ABEE |
| --- |
| 21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565 |

DEMO ABEE

21ST Km NATIONAL HIGHWAY ATHENS-LAMIA, 14565

RITAMINE

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| BALU EPE |
| --- |
| 30 Km ATHENS-LAVRION, MARKOPOULO |

BALU EPE

30 Km ATHENS-LAVRION, MARKOPOULO

NIBERAN

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| SANDOZ GMBH, KUNDL, AVSTRIJA |
| --- |
| BIOCHEMIESTRASSE 10, A-6250, KUNDL AVSTRIJA |

SANDOZ GMBH, KUNDL, AVSTRIJA

BIOCHEMIESTRASSE 10, A-6250, KUNDL AVSTRIJA

NIMESULIDE / HEXAL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| SANDOZ GMBH, KUNDL, AVSTRIJA |
| --- |
| BIOCHEMIESTRASSE 10, A-6250, KUNDL AVSTRIJA |

SANDOZ GMBH, KUNDL, AVSTRIJA

BIOCHEMIESTRASSE 10, A-6250, KUNDL AVSTRIJA

NIMESULIDE / HEXAL

100 mg

Prašek za peroralno raztopino

PERORALNA UPORABA

Grčija

| VELKA HELLAS AEBE |
| --- |
| KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451 |

VELKA HELLAS AEBE

KAPODISTRIOU & KORINTHOU 12, NEO PSYCHIKO, 15451

NAOFID

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| 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

TABLETA

PERORALNA UPORABA

Grčija

| VOCATE PHARMAKEFTIKI A.E. |
| --- |
| GOUNARI 150, GLYFADA, 16674 |

VOCATE PHARMAKEFTIKI A.E.

GOUNARI 150, GLYFADA, 16674

TRANZICALM

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| 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

TABLETA

PERORALNA UPORABA

Grčija

| FARAN ABEE |
| --- |
| PRODUCTION AND TRADING MEDICINES |
| AVEROF 19A, ATHENS, 10433 |

FARAN ABEE

PRODUCTION AND TRADING MEDICINES

AVEROF 19A, ATHENS, 10433

AFLOGEN

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

100 mg

ZRNCA ZA PERORALNO RAZTOPINO

PERORALNA UPORABA

Grčija

| GEROLYMATOS P.N. AEBE |
| --- |
| ASKLEPIOU, KRYONERI, ATTIKIS |

GEROLYMATOS P.N. AEBE

ASKLEPIOU, KRYONERI, ATTIKIS

EDRIGYL

200 mg

SVEČKA

REKTALNA UPORABA

Grčija

| 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

TABLETA

PERORALNA UPORABA

Grčija

| COUP ABEE |
| --- |
| AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235 |

COUP ABEE

AGIAS VARVARAS 53-55, DAFNI, ATHENS, 17235

MELICAT

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| PHARMACYPRIA HELLAS A.E. |
| --- |
| PASTER 6, AMPELOKIPOI, 11521 |

PHARMACYPRIA HELLAS A.E.

PASTER 6, AMPELOKIPOI, 11521

LALIDE

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| PHARMACYPRIA HELLAS A.E. |
| --- |
| PASTER 6, AMPELOKIPOI, 11521 |

PHARMACYPRIA HELLAS A.E.

PASTER 6, AMPELOKIPOI, 11521

LALIDE

50 mg /5 ml

Peroralna suspenzija

PERORALNA UPORABA

Grčija

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

Šumeča tableta

PERORALNA UPORABA

Grčija

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

100 mg

ZRNCA ZA PERORALNO RAZTOPINO

PERORALNA UPORABA

Grčija

| INTERMED ABEE |
| --- |
| KALYFTAKI 27, ATHENS |

INTERMED ABEE

KALYFTAKI 27, ATHENS

DOLOSTOP

200 mg

SVEČKA

REKTALNA UPORABA

Grčija

| EVAGGELOS KALOFOLIAS & SIA O.E. |
| --- |
| MENANDROU 54, ATHENS, 10431 |

EVAGGELOS KALOFOLIAS & SIA O.E.

MENANDROU 54, ATHENS, 10431

ALGOVER

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| FARMILIA E.E. |
| --- |
| FAVIEROU 48, ATHENS |

FARMILIA E.E.

FAVIEROU 48, ATHENS

AUROMELID

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| AURORA PHARMACEUTICALS EPE |
| --- |
| EVROU & MESSINIAS, GERAKAS, 15344 |

AURORA PHARMACEUTICALS EPE

EVROU & MESSINIAS, GERAKAS, 15344

SUDINET

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| LEOVAN M. LEON & SIA E.E. |
| --- |
| ARGONAFTON 22, ARGYROUPOLI, 16452 |

LEOVAN M. LEON & SIA E.E.

ARGONAFTON 22, ARGYROUPOLI, 16452

LASAZIN

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| PHARMACHEM EPE |
| --- |
| YMITOU 73, VRILISSIA, ATTIKIS, 15235 |

PHARMACHEM EPE

YMITOU 73, VRILISSIA, ATTIKIS, 15235

NIMESULIDE / PHARMACHEM

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| ANTONIOS POLYCHRONIS OF MARINOU |
| --- |
| IONIAS 29, NEO PSYCHIKO, 15451 |

ANTONIOS POLYCHRONIS OF MARINOU

IONIAS 29, NEO PSYCHIKO, 15451

OMNIBUS

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| ZWITTER PHARMACEUTICALS EPE, GRČIJA |
| --- |
| PENTELIS AVENUE 34-36, ATHENS, 15234 |

ZWITTER PHARMACEUTICALS EPE, GRČIJA

PENTELIS AVENUE 34-36, ATHENS, 15234

RHEMID

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| MED-ONE S.A., HELLAS |
| --- |
| PARNITHOS AVENUE 211, AHARNAI, 13671 |

MED-ONE S.A., HELLAS

PARNITHOS AVENUE 211, AHARNAI, 13671

ALGOSULID

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| MED-ONE S.A., HELLAS |
| --- |
| PARNITHOS AVENUE 211, AHARNAI, 13671 |

MED-ONE S.A., HELLAS

PARNITHOS AVENUE 211, AHARNAI, 13671

ALGOSULID

100 mg

Prašek za peroralno raztopino

PERORALNA UPORABA

Grčija

| LAMDA PHARMAKEFTIKI A.E. |
| --- |
| EVRIPIDOU 18, ATHENS, 10559 |

LAMDA PHARMAKEFTIKI A.E.

EVRIPIDOU 18, ATHENS, 10559

NIMESORAL

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| MEDARTE FARMAKEFTIKI ABEE |
| --- |
| SPYROU VRETTOU 10, METAMORFOSI, 14452 |

MEDARTE FARMAKEFTIKI ABEE

SPYROU VRETTOU 10, METAMORFOSI, 14452

NIMESULIDE / MEDICON

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| FARMAMUST EPE |
| --- |
| PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443 |

FARMAMUST EPE

PANTAZOPOULOU SQUARE 7, KOLONOS, ATTIKIS, 10443

LOVIREM

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| 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

TABLETA

PERORALNA UPORABA

Grčija

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

100 mg

TABLETA

PERORALNA UPORABA

Grčija

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

200 mg

SVEČKA

REKTALNA UPORABA

Grčija

| LAVIPHARM HELLAS A.E. |
| --- |
| AGIAS MARINAS, PAEANIA, ATTIKIS, 19002 |

LAVIPHARM HELLAS A.E.

AGIAS MARINAS, PAEANIA, ATTIKIS, 19002

AULIN

100 mg

ZRNCA ZA PERORALNO RAZTOPINO

PERORALNA UPORABA

Madžarska

Chinoin Zrt.1045 Budapest, Tó u.1-5.

Winsulid

100 mg

Zrnca

Peroralna uporaba

Madžarska

Chinoin Zrt.1045 Budapest, Tó u.1-5.

Winsulid

100 mg

Tableta

Peroralna uporaba

Madžarska

Sanofi-Aventis 1045 Budapest, Tó u.1-5

Mesulid

100 mg

Zrnca

Peroralna uporaba

Madžarska

Sanofi-Aventis 1045 Budapest, Tó u.1-5

Mesulid

100 mg

Tableta

Peroralna uporaba

Madžarska

PannonPharma Gyógyszergyártó Kft. 1016 Budapest Derék u.2.

Nimelid

100 mg

Tableta

Peroralna uporaba

Madžarska

Eurodrug Lab.BV 4032 Debrecen,Bartha Boldizsár u.7.

Nidol

100 mg

Tableta

Peroralna uporaba

Madžarska

LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, Italija

Xilox

100 mg

Zrnca

Peroralna uporaba

Irska

Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 Irska

Aulin

100 mg

Tableta

Peroralna uporaba

Irska

Helsinn Birex Pharm. Ltd. Damastown Mulhuddart Dublin 15 Irska

Aulin

100 mg

Zrnca

Peroralna uporaba

Irska

Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 Irska

Mesulid

100 mg

Tableta

Peroralna uporaba

Irska

Helsinn Birex Therapeutics Ltd. Damastown Mulhuddart Dublin 15 Irska

Mesulid

100 mg

Zrnca

Peroralna uporaba

Irska

Pinewood Laboratories Ltd Ballymacarbry Clonmel Co. Tipperary Irska

Mesine

100 mg

Tableta

Peroralna uporaba

Irska

PCO Manufacturing Ltd. Unit 222 Western Industrial Estate, Naas Road, Dublin 12 Irska

Aulin

100 mg

Tableta

Peroralna uporaba

Irska

B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, Velika Britanija

Aulin

100 mg

Zrnca

Peroralna uporaba

Irska

B + S Healthcare Unit 4 Bradfield Road, Ruislip, Middlesex HA4, Velika Britanija

Aulin

100 mg

Tableta

Peroralna uporaba

Italija

FRANCIA FARMAC.IND.FAR.BIO.Srl Via DEI PESTAGALLI, 7 20138 MILANO

ALGIMESIL

100 mg

Zrnca

Peroralna uporaba

Italija

FRANCIA FARMAC.IND.FAR.BIO.Srl Via DEI PESTAGALLI, 7 20138 MILANO

ALGIMESIL

100 mg

Tableta

Peroralna uporaba

Italija

SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO

ALGOLIDER

100 mg

Zrnca

Peroralna uporaba

Italija

SIAR PHARMA Srl, VIA VERDI 33, 20060 BUSSERO

ALGOLIDER

100 mg

Tableta

Peroralna uporaba

Italija

SELVI LABORAT.BIOTERAPICO SpA, VIA PROCOIO, 28, 00065 FIANO ROMANO

ANTALGO

100 mg

Zrnca

Peroralna uporaba

Italija

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

200 mg

Svečka

rektalna uporaba

Italija

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

100 mg

Zrnca

Peroralna uporaba

Italija

ECOBI FARMACEUTICI Sas, VIA E.BAZZANO, 26, 16019 RONCO SCRIVIA

AREUMA

100 mg

Tableta

Peroralna uporaba

Italija

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

200 mg

Svečka

rektalna uporaba

Italija

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

100 mg

Zrnca

Peroralna uporaba

Italija

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN

100 mg

Tableta

Peroralna uporaba

Italija

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN BETA

400 mg

Zrnca

Peroralna uporaba

Italija

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN BETA

400 mg

Tableta

Peroralna uporaba

Italija

ROCHE SpA, P.ZZA DURANTE, 11, 20131 MILANO

AULIN MITE

50 mg

Zrnca

Peroralna uporaba

Italija

AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO

DELFOS

100 mg

Zrnca

Peroralna uporaba

Italija

AGIPS FARMACEUTICI Srl, VIA AMENDOLA, 4, 16035 RAPALLO

DELFOS

100 mg

Tableta

Peroralna uporaba

Italija

SARDA PHARMACEUTICA Srl, VIA CASTIGLIONE 92/B 09100 CAGLIARI

DIMESUL

100 mg

Zrnca

Peroralna uporaba

Italija

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Zrnca

Peroralna uporaba

Italija

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Tableta

Peroralna uporaba

Italija

SO.SE.PHARM Srl, VIA DEI CASTELLI ROMANI, 22, 00040 POMEZIA

DOMES

100 mg

Orodisperzibilna tableta

Peroralna uporaba

Italija

SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO

EDEMAX

100 mg

Zrnca

Peroralna uporaba

Italija

SIFI SpA, VIA ERCOLE PATTI 36, 95020 LAVINAIO - ACI S.ANTONIO

EDEMAX

100 mg

Tableta

Peroralna uporaba

Italija

AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA

EFRIDOL

100 mg

Zrnca

Peroralna uporaba

Italija

AESCULAPIUS FARMACEUTICI Srl,VIA COZZAGLIO, 24, 25125 BRESCIA

EFRIDOL

100 mg

Tableta

Peroralna uporaba

Italija

I.B.N. SAVIO Srl, VIA E.BAZZANO, 14, 16019 RONCO SCRIVIA

EUDOLENE

100 mg

Zrnca

Peroralna uporaba

Italija

NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA

FANSIDOL

100 mg

Zrnca

Peroralna uporaba

Italija

NCSN FARMACEUTICI Srl, VIA SVETONIO, 6, 00136 ROMA

FANSIDOL

100 mg

Kapsula

Peroralna uporaba

Italija

SOFAR SpA, VIA ISONZO, 8, 20100 MILANO

FANSULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

SOFAR SpA, VIA ISONZO, 8, 20100 MILANO

FANSULIDE

100 mg

Tableta

Peroralna uporaba

Italija

PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO

FLAMINIDE

100 mg

Zrnca

Peroralna uporaba

Italija

PRODOTTI FORMENTI Srl, VIA CORREGGIO, 43, 20149 MILANO

FLAMINIDE

100 mg

Tableta

Peroralna uporaba

Italija

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Svečka

rektalna uporaba

Italija

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Zrnca

Peroralna uporaba

Italija

C.T. LAB.FARMACEUTICO Srl, VILLA SAYONARA; STR.SOLARO 75/77, 18038 SANREMO

FLOLID

100 mg

Tableta

Peroralna uporaba

Italija

ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA

IDEALID

100 mg

Tableta

Peroralna uporaba

Italija

MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA

ISODOL

100 mg

Zrnca

Peroralna uporaba

Italija

MAGIS FARMACEUTICI SpA, VIA CACCIAMALI, 34-36-38/B, 25125 BRESCIA

ISODOL

100 mg

Tableta

Peroralna uporaba

Italija

BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO

LEDOREN

100 mg

Zrnca

Peroralna uporaba

Italija

BONISCONTRO & GAZZONE Srl, VIA PAVIA,6, 20136 MILANO

LEDOREN

100 mg

Tableta

Peroralna uporaba

Italija

ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA

LIDERSOLV

100 mg

Zrnca

Peroralna uporaba

Italija

ALTA CARE LAB.ITALIA Srl, VIALE DELLE MILIZIE, 134, 00192 ROMA

LIDERSOLV

100 mg

Tableta

Peroralna uporaba

Italija

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

200 mg

Svečka

rektalna uporaba

Italija

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

100 mg

Zrnca

Peroralna uporaba

Italija

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID

100 mg

Tableta

Peroralna uporaba

Italija

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID FAST

400 mg

Zrnca

Peroralna uporaba

Italija

HELSINN BIREX PHARMAC.LTD, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

MESULID MITE

50 mg

Zrnca

Peroralna uporaba

Italija

NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA

NERELID

100 mg

Zrnca

Peroralna uporaba

Italija

NEW RESEARCH Srl, V.DELLA TENUTA DI TORRENOVA142, 00133 ROMA

NERELID

100 mg

Kapsula

Peroralna uporaba

Italija

I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA

NIDE

100 mg

Zrnca

Peroralna uporaba

Italija

I.BIR.N Srl Ist.Biot.Nazionale, VIA VITTORIO GRASSI, 9/15, 00155 ROMA

NIDE

100 mg

Kapsula

Peroralna uporaba

Italija

MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI

NIDEMOL

200 mg

Svečka

rektalna uporaba

Italija

MOLTENI & C. F.LLI ALITTI SpA, STR.STATALE 67, LOC.GRANATIERI, 50018 SCANDICCI

NIDEMOL

100 mg

Zrnca

Peroralna uporaba

Italija

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Zrnca

Peroralna uporaba

Italija

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Tableta

Peroralna uporaba

Italija

ITALFARMACO SpA, V.LE FULVIO TESTI, 330, 20126 MILANO

NIMEDEX

400 mg

Zrnca

Peroralna uporaba

Italija

KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO

NIMENOL

100 mg

Zrnca

Peroralna uporaba

Italija

KRUGHER PHARMA Srl, VIA VOLTURNO, 10/12, 50019 SESTO FIORENTINO

NIMENOL

100 mg

Zrnca

Peroralna uporaba

Italija

LAB.GUIDOTTI SpA, VIA LIVORNESE, 897 56010 LA VETTOLA - PISA

NIMESULENE

200 mg

Svečka

rektalna uporaba

Italija

LAB.GUIDOTTI SpA, VIA LIVORNESE, 897, 56010 LA VETTOLA - PISA

NIMESULENE

100 mg

Zrnca

Peroralna uporaba

Italija

LAB.GUIDOTTI SpA, VIA LIVORNESE, 897, 56010 LA VETTOLA - PISA

NIMESULENE

100 mg

Tableta

Peroralna uporaba

Italija

ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA

NIMESULIDE

200 mg

Svečka

rektalna uporaba

Italija

DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

200 mg

Svečka

rektalna uporaba

Italija

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

200 mg

Svečka

rektalna uporaba

Italija

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, CINISELLO BALSAMO

NIMESULIDE

200 mg

Svečka

rektalna uporaba

Italija

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

200 mg

Svečka

rektalna uporaba

Italija

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Žvečljiva tableta

Peroralna uporaba

Italija

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

ANGENERICO SpA, VIA NOCERA UMBRA, 75, 00181 ROMA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

DOROM Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

POLIFARMA SpA, VIALE DELL'ARTE, 69, 00144 ROMA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

JET GENERICI Srl, VIA MARIO LALLI, 8, 56127 PISA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

ALMUS Srl, VIA CESAREA, 11/10, 16121 GENOVA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA

NIMESULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

BENEDETTI SpA, VICOLO DE'BACCHETTONI, 1, 51100 PISTOIA

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

MIPHARM SpA, VIA QUARANTA, 12, 20141 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

FARMAC.FORMENTI SpA, VIA CORREGGIO, 43, 20149 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

LABORATORI ALTER Srl, VIA EGADI, 7, 20144 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

TEVA PHARMA ITALIA Srl, VIA GIULIO RICHARD, 7, 20143 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

MERCK GENERICS ITALIA SpA, VIA AQUILEIA, 35, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

GET Srl, 'VIA DANTE ALIGHIERI, 73, 18038 SANREMO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

ROBIN Srl, P.LE DURANTE FRANCESCO, 11, MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

DOC GENERICI Srl, VIA MANUZIO, 7, 20124 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

RANBAXY ITALIA SpA, P.ZA FILIPPO MEDA 3, 20121 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

PLIVA PHARMA SpA, VIA TRANQUILLO CREMONA, 10, 20092 CINISELLO BALSAMO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

HEXAL SpA, VIA PARACELSO, 16, 20041 AGRATE BRIANZA

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

UNION HEALTH Srl, VIA ROCCAMANDOLFI, 1, 00156 ROMA

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

EG SpA, VIA DOMENICO SCARLATTI, 31, 20124 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

RATIOPHARM GMBH, VIALE MONZA, 270, 20128 MILANO

NIMESULIDE

100 mg

Tableta

Peroralna uporaba

Italija

SANDOZ SpA, L.GO U.BOCCIONI, 1, 21040 ORIGGIO

NIMESULIDE

100 mg

Kapsula

Peroralna uporaba

Italija

FARMAC.CABER SpA, VIALE CITTA' D'EUROPA, 681, ROMA

NIMS

100 mg

Zrnca

Peroralna uporaba

Italija

LEVOFARMA Srl, VIA CONFORTI, 42, 84083 CASTEL SAN GIORGIO

NOALGOS

100 mg

Zrnca

Peroralna uporaba

Italija

LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO

NOXALIDE

100 mg

Zrnca

Peroralna uporaba

Italija

LAMPUGNANI FARMACEUTICI SpA, VIA BIANCA MARIA VISCONTI, 20122 MILANO

NOXALIDE

60 ml 5 %

Peroralne kapljice

Peroralna uporaba

Italija

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

ORONIME

100 mg

Orodisperzibilna tableta

Peroralna uporaba

Italija

PANTAFARM Srl, VIA PALESTRO, 14, 00185 ROMA

PANTAMES

100 mg

Orodisperzibilna tableta

Peroralna uporaba

Italija

VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA

REMOV

100 mg

Zrnca

Peroralna uporaba

Italija

VECCHI & PIAM Sapa, VIA PADRE G.SEMERIA, 5, 16131 GENOVA

REMOV

100 mg

Tableta

Peroralna uporaba

Italija

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

200 mg

Svečka

rektalna uporaba

Italija

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

100 mg

Zrnca

Peroralna uporaba

Italija

IST.CHIM.INTERN RENDE Srl, VIA SALARIA, 1240, 00138 ROMA

RESULIN

100 mg

Tableta

Peroralna uporaba

Italija

NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

REUMALIDE

200 mg

Svečka

rektalna uporaba

Italija

NOVARTIS CONSUMER HEALTH SpA, LARGO UMBERTO BOCCIONI, 1, 21040 ORIGGIO

REUMALIDE

100 mg

Zrnca

Peroralna uporaba

Italija

MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO

SOLVING

100 mg

Zrnca

Peroralna uporaba

Italija

MDM SpA, VIALE PAPINIANO, 22/B, 20100 MILANO

SOLVING

100 mg

Tableta

Peroralna uporaba

Italija

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Zrnca

Peroralna uporaba

Italija

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Tableta

Peroralna uporaba

Italija

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Zrnca

Peroralna uporaba

Italija

FARMAC.DAMOR SpA, VIA EMILIO SCAGLIONE, 27, 80145 NAPOLI

SULIDAMOR

100 mg

Tableta

Peroralna uporaba

Italija

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

SULIDE

100 mg

Zrnca

Peroralna uporaba

Italija

TAD PHARMA ITALIA Srl, VIA FELICE CASATI, 16, 20124 MILANO

SULIDE

100 mg

Tableta

Peroralna uporaba

Italija

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

200 mg

Svečka

rektalna uporaba

Italija

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

100 mg

Zrnca

Peroralna uporaba

Italija

ERREKAPPA EUROTERAPICI SpA, VIA C.MENOTTI, 1/A, 20129 MILANO

SULMEDIL

100 mg

Tableta

Peroralna uporaba

Latvija

Helsinn Birex Pharmaceutical Ltd., Damastown, Mulhurddart, Dublin 15, Irska

Mesulid

100 mg

Tableta

Peroralna uporaba

Latvija

Laboratori Guidotti S. P. A., Via Trieste 40, I-56126 Pisza, Italija

Nimesil

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Latvija

Medochemie Ltd., P. O. Box 51409, CY-3505 Limassol, Ciper

Aponil

100 mg

Tableta

Peroralna uporaba

Latvija

Zentiva a. S., Nitrianska 100, 92027 Hlohovec, Slovaška

Coxtral

100 mg

Tableta

Peroralna uporaba

Litva

Medochemie Ltd., P. O. Box 51409 CY-3505 Limassol, Ciper

Aponil

100 mg

Tableta

Peroralna uporaba

Litva

Zentiva a. s., U kabelovny 130102 37 Praha 10 Dolni Mecholupy, Češka

Coxtral

100 mg

Tableta

Peroralna uporaba

Litva

Helsinn Birex Pharmaceuticals Ltd., Damastown Mulhuddart Dublin 15, Irska

Mesulid

100 mg

Tableta

Peroralna uporaba

Litva

Laboratori Guidotti S.p.A., Via Livornese, 897-56010 Pisa-La Viettola, Italija

Nimesil

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Malta

Vecchi & C Piam S A, Via Padre G Semeria, 5, Genoa 16131, Italija

Remov

100 mg

Tableta

Peroralna uporaba

Poljska

| MEDICOM INTERNATIONAL S.R.O., |
| --- |
| Páteřní 7 |
| 635 00 Brno, Češka |

MEDICOM INTERNATIONAL S.R.O.,

Páteřní 7

635 00 Brno, Češka

AULIN

100 mg

Tableta

Peroralna uporaba

Poljska

MEDICOM INTERNATIONAL S.R.O., Páteřní 7635 00 Brno, Češka

AULIN

100 mg

Zrnca za peroralno raztopino

Peroralna uporaba

Poljska

Laboratori Guidotti S. P. A., Via Livornese 897, La Vettola, 56010 Pisa, Italija

NIMESIL

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Poljska

Zentiva a.s. U Kabelovny 130 Dolni Mecholupy 102 37 Praque 10

COXTRAL

100 mg

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Svečka

Rektalna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| Labesfal - Laboratórios Almiro, |
| --- |
| S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios Almiro,

S.A. 3465-051 Campo de Besteiros

Nimalge

200 mg

Svečka

Rektalna uporaba

Portugalska

| 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

Obložena tableta

Peroralna uporaba

Portugalska

| 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

Obložena tableta

Peroralna uporaba

Portugalska

| 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

Prašek za peroralno raztopino

Peroralna uporaba

Portugalska

| 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

Svečka

Rektalna uporaba

Portugalska

Laboratori Guidotti, S.p.A. Via Trieste, 40 I-56126 Pisa

Nimesulene

100 mg

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

Edol Themaxis - Produtos Farmacêuticos S.A. Avenida 25 de Abril, no 6 - 6A 2795-195 Linda-a-Velha

Nimesulida Edol

100 mg

Tableta

Peroralna uporaba

Portugalska

| 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

Obložena tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek za peroralno raztopino

Peroralna uporaba

Portugalska

Companhia Portuguesa Higiene Pharma - Produtos Farmacêuticos, S.A. Rua dos Bem Lembrados, 141 - Manique 2645-471 Alcabideche

Nimesulida Gerilide 100 mg Comprimidos

100 mg

Tableta

Peroralna uporaba

Portugalska

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

Prašek za peroralno raztopino

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Obložena tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek za peroralno raztopino

Peroralna uporaba

Portugalska

| Labesfal - Laboratórios |
| --- |
| Almiro, S.A. 3465-051 Campo de Besteiros |

Labesfal - Laboratórios

Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Labesfal

200 mg

Svečka

Rektalna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Obložena tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

Merck Genéricos - Produtos Farmacêuticos, Lda. Rua Alfredo da Silva, 3 C - 4o 1300-040 Lisboa

100 mg

Tableta

Peroralna uporaba

Portugalska

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

Prašek za peroralno raztopino

Peroralna uporaba

Portugalska

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

Obložena tableta

Peroralna uporaba

Portugalska

Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Nilmide 100 mg Comprimidos

100 mg

Tableta

Peroralna uporaba

Portugalska

Labesfal - Laboratórios Almiro, S.A. 3465-051 Campo de Besteiros

Nimesulida Nilmide 100 mg Granulado Para Suspensão Oral

100 mg

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| Pharmakern Portugalska - |
| --- |
| Produtos Farmacêuticos, Sociedade Unipessoal, Lda. Av. José Gomes Ferreira, 11 - 3o, Sala 31 - Edifício Atlas II 1495-139 Miraflores - Algés |

Pharmakern Portugalska -

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

Tableta

Peroralna uporaba

Portugalska

| Ranbaxy Portugalska - |
| --- |
| Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto |

Ranbaxy Portugalska -

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

Tableta

Peroralna uporaba

Portugalska

| Ranbaxy Portugalska - |
| --- |
| Comércio e Desenvol. de Produtos Farmacêuticos, Unip., Lda. Rua do Campo Alegre, 1306, 3o - Sala 301/302 - Edifício Botânico 4150-174 Porto |

Ranbaxy Portugalska -

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

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Portugalska

Sandoz Farmacêutica, Lda. Rua do Centro Empresarial - Edifício 3 - Loja 1 - Quinta da Beloura 2710-693 Sintra

Nimesulida Sandoz 100 mg Comprimidos

100 mg

Tableta

Peroralna uporaba

Portugalska

Decafarma - Comércio de Produtos Farmacêuticos, Lda Centro Empresarial Sintra Estoril, V, Armazém E 3 2710-144 Sintra

Nimesulida Sulimed 100 mg Comprimidos

100 mg

Tableta

Peroralna uporaba

Portugalska

Laboratórios Atral, S.A Vala do Carregado 2600-726 Castanheira do Ribatejo

Ribantil

100 mg

Obložena tableta

Peroralna uporaba

Portugalska

| 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

Tableta

Peroralna uporaba

Romunija

Faran Laboratories SA/Imedica SA, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti

AFLOGEN

100 mg

Tableta

Peroralna uporaba

Romunija

Medochemie LTD, Str. Prof. Dr. Ion Cantacuzino nr. 5, sector 1, Bucuresti

Aponil

100 mg

Tableta

Peroralna uporaba

Romunija

C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti

Aulin

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Romunija

C.S.C. PHARMACEUTICALS, Drumul Sarii nr. 108, sector 6 Bucuresti

Aulin

100 mg

Tableta

Peroralna uporaba

Romunija

Zentiva AS, B-dul Theodor Pallady nr. 50, 032266 Bucuresti

Coxtral

100 mg

Tableta

Peroralna uporaba

Romunija

ANFARM HELLAS SA/Imedica, Sos. Bucuresti – Ploiesti Nr. 141D Sector 1, Bucuresti

Lemesil

100 mg

Tableta

Peroralna uporaba

Romunija

| LABORATORI GUIDOTTI S.p.A., Via Livornese 897, |
| --- |
| I - 56010 La Vettola, PISA, Italija |

LABORATORI GUIDOTTI S.p.A., Via Livornese 897,

I - 56010 La Vettola, PISA, Italija

Nimesil

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Romunija

Terapia SA, Str. Fabricii Nr.124, 3400 Cluj Napoca, Jud. Cluj

Nimesulid

100 mg

Tableta

Peroralna uporaba

Romunija

LABORMED PHARMA SRL,Splaiul Independentei Nr. 319, Sector 6, Bucuresti

Nimesulid LPH 100 mg

100 mg

Tableta

Peroralna uporaba

Romunija

MAGISTRA C & C, Str. Aviator Belghiru Nr. 9, 8700 Constanta, Jud. Constanta

Nimesulid 100 mg

100 mg

Tableta

Peroralna uporaba

Romunija

ARENA GROUP SA, Str. Stefan Mihaileanu Nr.31, Sector 2, 73101 Bucuresti

Nimesulid Arena 100 mg

100 mg

Tableta

Peroralna uporaba

Romunija

SLAVIA PHARM SRL, Str. Stirbei Voda Nr.53-55, Sector 1, Bucuresti

Nimesulid Slavia

100 mg

Tableta

Peroralna uporaba

Romunija

FARMACEUTICI DAMUR SPA, Calea Dorobantilor Nr.113 Ap.35, Cluj, Jud. Cluj

Sulidamor

100 mg

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Slovaška

Medicom International s.r.o., Brno, Češka

AULIN 100 mg granulát

100 mg

Zrnca

Peroralna uporaba

Slovaška

Medicom International s.r.o., Brno, Češka

AULIN 100 mg tablety

100 mg

Tableta

Peroralna uporaba

Slovaška

Zentiva a.s. , Praha, Češka

COXTRAL

100 mg

Tableta

Peroralna uporaba

Slovaška

CSC Pharmaceuticals Handels GmbH, Wien, Avstrija

MESULID

100 mg

Tableta

Peroralna uporaba

Slovaška

Medicom International s.r.o., Brno, Češka

NIMED

100 mg

Tableta

Peroralna uporaba

Slovaška

LABORATORI GUIDOTTI S.p.A., Via Livornese 897, I - 56010 La Vettola, PISA, Italija

Nimesil

100 mg

Zrnca za peroralno suspenzijo

Peroralna uporaba

Slovenija

CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenija

Aulin

100 mg

Tableta

Peroralna uporaba

Slovenija

CSC Pharma d.o.o. JANA HUSA 1a, SI-1000 Ljubljana Slovenija

Aulin

100 mg

Prašek in vehikel za peroralno suspenzijo

Peroralna uporaba

Španija

HELSINN BIREX PHARMACEUTICALS LTD Damastown Mulhuddart, County Dublin,15 Irska

GUAXAN 100 mg comprimidos

100 mg

Tableta

Peroralna uporaba

---

DODATEK X

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica EU/EEA | Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila | Vsebina
  (koncentracija) |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6, |
| A-1140 Dunaj |

Država članica EU/EEA

Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Vsebina

(koncentracija)

Avstrija

GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,

A-1140 Dunaj

Augmentin intravenös 550 mg – Trockenstechampullen

500/50 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 50 mg/vialo

Augmentin intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung

1 000/100 mg

Prašek za raztopino za infundiranje

Intravenska uporaba

1 000 mg: 100 mg/vialo

Augmentin intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung

2 000/200 mg

Prašek za raztopino za infundiranje

Intravenska uporaba

2 000 mg: 200 mg/vialo

Augmentin 625 mg - lösliche Tabletten

500/125 mg

Disperzibilna tableta

Peroralna uporaba

Augmentin

625 mg – Filmtabletten

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 1 g – Filmtabletten

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 457 mg/5 ml – Trockensaft

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

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

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 50 mg/10,5 ml

Clavamox intravenös 1,1 g - Trockensubstanz zur Infusionsbereitung

1 000/100 mg

Prašek za raztopino za infundiranje

Intravenska uporaba

1 000 mg: 100 mg/100 ml

Clavamox intravenös 2,2 g - Trockensubstanz zur Infusionsbereitung

2 000/200 mg

Prašek za raztopino za infundiranje

Intravenska uporaba

2 000 mg: 200 mg/100 ml

Clavamox 625 mg - lösliche Tabletten

500/125 mg

Disperzibilna tableta

Peroralna uporaba

Clavamox 625 mg – Filmtabletten

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavamox 1 g – Filmtabletten

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavamox 156,25 mg/5 ml – Trockensaft

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125/31,25 mg/5 ml

Clavamox 312,5 mg/5 ml – Trockensaft

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250/62,5 mg/5 ml

Clavamox Duo – Trockensaft

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400/57 mg/5 ml

Belgija

| 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

Prašek za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 50 mg/10,5 ml ali 25 ml

Augmentin P

1 000/100 mg

Prašek za infundiranje

Intravenska uporaba

1 000 mg: 100 mg/50 ml

Augmentin

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20 ml

Augmentin

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg: 200 /100 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin

500/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentin Retard

1 000/62,5 mg

Tableta s prirejenim sproščanjem

Peroralna uporaba

Bolgarija

| GlaxoSmithKline EOOD |
| --- |
| Ivan Vasov Complex |
| Dimitar Manov street, bl.10, 1408 Sofija, Bolgarija |

GlaxoSmithKline EOOD

Ivan Vasov Complex

Dimitar Manov street, bl.10, 1408 Sofija, Bolgarija

Augmentin

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Ciper

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| VB |

SmithKline Beecham plc

980 Great West Road

Brentford

Middlesex TW8 9GS

VB

Augmentin

500/100 mg

Prašek za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml ali 60 ml

Augmentin

1 000/200 mg

Prašek za injiciranje ali infundiranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml ali 120 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

| Laboratórios BIAL |
| --- |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugalska |

Laboratórios BIAL

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugalska

Noprilam

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Noprilam DT

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Noprilam

156,23 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,23 mg/5 ml

Noprilam

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Noprilam DT

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Češka

| SmithKline Beecham plc trading as |
| --- |
| SmithKline Beecham Pharmaceuticals |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| Velika Britanija |

SmithKline Beecham plc trading as

SmithKline Beecham Pharmaceuticals

980 Great West Road,

Brentford, Middlesex

TW8 9GS

Velika Britanija

Augmentin 600 mg

500/100 mg

Prašek za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 100 mg/ 10,5 ml ali 60 ml

Augmentin 1,2 g

1 000/200 mg

Prašek za injiciranje ali infundiranje

Intravenska uporaba

1 000 mg: 200 mg/ 20,9 ml ali 120 ml

| SmithKline Beecham plc trading as |
| --- |
| SmithKline Beecham Pharmaceuticals |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| Velika Britanija |

SmithKline Beecham plc trading as

SmithKline Beecham Pharmaceuticals

980 Great West Road,

Brentford, Middlesex

TW8 9GS

Velika Britanija

Augmentin 375 mg

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 625 mg

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 1 g

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 156 mg/5 ml

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin 312 mg/5 ml

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin Duo

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin SR

1 000/62,5 mg

Tableta s prirejenim sproščanjem

Peroralna uporaba

Danska

| Meda AS |
| --- |
| Solvang 8 |
| DK-3450 Allerød |
| Danska |

Meda AS

Solvang 8

DK-3450 Allerød

Danska

Spektramox

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Spektramox

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Spektramox

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Spektramox 2:1

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Spektraforte

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Estonija

| SmithKline Beecham plc. |
| --- |
| 980 Great West Road, Brentford |
| Middlesex TW8 9GS |
| Velika Britanija |

SmithKline Beecham plc.

980 Great West Road, Brentford

Middlesex TW8 9GS

Velika Britanija

Augmentin

1 000/200 mg

Prašek za injiciranje ali infundiranje

Intravenska uporaba

1 000 mg: 200 mg/ 20,9 ml ali 120 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Finska

| SmithKline Beecham plc |
| --- |
| 980 Great West Road |
| Brentford, Middlesex TW8 9GS |
| VB |

SmithKline Beecham plc

980 Great West Road

Brentford, Middlesex TW8 9GS

VB

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin (80/11, 97 mg/ml)

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Orion-yhtymä Oyj, Orionintie 1, 02200 Espoo

Clavurion

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavurion

200/28,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

200 mg: 28,5 mg/5 ml

Clavurion

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Francija

| 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

Prašek za raztopino za injiciranje

IN Prašek in vehikel za raztopino za injiciranje

Intravenska uporaba

500 mg: 50 mg

Augmentin IV

ADULTES

500/100 mg

Prašek za raztopino za injiciranje

Intravenska uporaba

500 mg: 100 mg

Augmentin IV

ENFANTS

1 000/100 mg

Prašek za raztopino za injiciranje

Intravenska uporaba

1 000 mg: 100 mg

Augmentin IV

ADULTES

1 000/200 mg

Prašek za raztopino za injiciranje

IN Prašek in vehikel za raztopino za injiciranje

Intravenska uporaba

1 000 mg: 200 mg

Augmentin IV

ADULTES

2 000/200 mg

Prašek za raztopino za injiciranje

Intravenska uporaba

2 000 mg: 200 mg

Augmentin

ADULTES

500/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

ENFANTS

100/12,5 mg/ml

Prašek za peroralno suspenzijo

Peroralna uporaba

100 mg: 12,5 mg/ml

Augmentin

NOURRISSONS

100/12,5 mg/ml

Prašek za peroralno suspenzijo

Peroralna uporaba

100 mg/12,5 mg/ml

Augmentin

NOURRISSONS

250/31,25 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentin

ENFANTS

500/62,5 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentin

ADULTES

1 000/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Duamentin

ADULTES

1 000/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| 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

Prašek za raztopino za infundiranje

Intravenska uporaba

250 mg: 25 mg

Augmentan i.v. 600 mg

500/100 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 100 mg

Augmentan i.v. 1,2 g

1 000/200 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 000 mg: 200 mg

Augmentan i.v. 2,2 g

2 000/200 mg

Prašek za raztopino za infundiranje

Intravenska uporaba

2 000 mg: 200 mg

Augmentan Tabs Tabletten

500/125 mg

Disperzibilna tableta

Peroralna uporaba

Augmentan Filmtabletten 875/125 mg

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentan Tropfen 50 mg/12,5 mg pro ml für Säuglinge

50/12,5 mg/ml

Prašek za peroralno suspenzijo

Peroralna uporaba

50: 12,5 mg/ml

Augmentan Trockensaft 25 mg/6,25 mg pro ml

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentan forte Trockensaft 50 mg/12,5 mg pro ml

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentan Kindersaft

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Grčija

| GlaxoSmithKline a.e.b.e, Leof. Kifissias 266, |
| --- |
| 152 32 Halandri, Atene |

GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,

152 32 Halandri, Atene

Augmentin

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

500/125 mg

Disperzibilna tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 m

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin SR

1 000/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Madžarska

| GlaxoSmithKline Kft. |
| --- |
| 1124 Bp, Csörsz u. 43 |
| Madžarska |

GlaxoSmithKline Kft.

1124 Bp, Csörsz u. 43

Madžarska

Augmentin

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

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

Filmsko obložena tableta

Peroralna uporaba

Augmentin Duo

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin Duo

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin Extra

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600mg: 42,9 mg/5 ml

Augmentin Extra

1 000/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

Islandija

| GlaxoSmithKline ehf. |
| --- |
| Þverholti 14 |
| 105 Reykjavík. |

GlaxoSmithKline ehf.

Þverholti 14

105 Reykjavík.

Augmentin IV

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin IV

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

tableta

Peroralna uporaba

Augmentin

875/125 mg

tableta

Peroralna uporaba

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Irska

| 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

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

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

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin Tablets 250 mg/125 mg

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin Dispersible Tablets 250 mg/125 mg

250/125 mg

Disperzibilna tableta

Peroralna uporaba

Augmentin Duo Tablets 500/125 mg

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 500/125 mg Film-Coated Tablets

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875 mg/125 mg Film Coated Tablets

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

Paediatric Suspension

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

Junior Suspension

125/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 62,5 mg/5 ml

Augmentin Duo

Suspension 400 mg/57 mg

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

| Clonmel Healthcare Limited |
| --- |
| Waterford Road |
| Clonmel |
| Tipperary |
| Irska |

Clonmel Healthcare Limited

Waterford Road

Clonmel

Tipperary

Irska

Clavamel 250 mg/125 mg Tablets

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavamel 125 mg/31.25 mg Paediatric Powder for Oral Suspension

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Clavamel 125 mg/62,5 mg Junior Powder for Oral Suspension

125/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 62,5 mg/5 ml

Italija

| 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

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20 ml

Augmentin

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg: 200 mg

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin

400/57 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentin

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

| Valeas S.p.A. |
| --- |
| via Vallisneri 10 |
| 20133 Milano |

Valeas S.p.A.

via Vallisneri 10

20133 Milano

Neoduplamox

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Neoduplamox

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Neoduplamox

400/57 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Neoduplamox

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

| 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

Filmsko obložena tableta

Peroralna uporaba

Clavulin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Clavulin

400/57 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Clavulin

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Latvija

| GlaxoSmithKline Latvia SIA |
| --- |
| Bruninieku 5, Riga, LV-1001, Latvija |

GlaxoSmithKline Latvia SIA

Bruninieku 5, Riga, LV-1001, Latvija

Augmentin

1 000/200 mg

Prašek za raztopino za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

Litva

| Beecham Group plc. |
| --- |
| 980 Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| Velika Britanija |

Beecham Group plc.

980 Great West Road

Brentford

Middlesex TW8 9GS

Velika Britanija

Augmentin

500/125mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

200/28,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

200 mg/28,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg/57 mg/5 ml

| UAB „GlaxoSmithKline Lietuva“ |
| --- |
| A. Goštauto g. 40A |
| LT-01112 Vilnius, Litva |

UAB „GlaxoSmithKline Lietuva“

A. Goštauto g. 40A

LT-01112 Vilnius, Litva

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg/42,9 mg/5 ml

Luksemburg

| 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

Prašek za injiciranje ali infundiranje

Intravenska uporaba

500 mg/ 50 mg/10,5 ml ali 25 ml

Augmentin P

1 000/100 mg

Prašek za infundiranje

Intravenska uporaba

1 000 mg/100 mg/50 ml

Augmentin

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg/200 mg/20 ml

Augmentin

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg/200 mg/100 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin

500/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentin Retard,

1 000/62,5 mg

Tableta s prirejenim sproščanjem

Peroralna uporaba

Malta

| Beecham Group plc |
| --- |
| 980 Great West Road, |
| Brentford, Middlesex |
| TW8 9GS |
| Velika Britanija |

Beecham Group plc

980 Great West Road,

Brentford, Middlesex

TW8 9GS

Velika Britanija

Augmentin Intravenous 600 mg

500/100 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin Intravenous 1,2 g

1 000/200 mg

Prašek za raztopino za injiciranje ali infundiranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

| GlaxoSmithKline (Ireland) Limited |
| --- |
| Stonemasons Way, |
| Rathfarnham |
| Dublin 16 |
| Irska |

GlaxoSmithKline (Ireland) Limited

Stonemasons Way,

Rathfarnham

Dublin 16

Irska

Augmentin 250/125 mg

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin Duo 500/125 tablets

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 875/125 mg tablets

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

| 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

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

| Laboratórios BIAL |
| --- |
| Portela & Ca, S.A. |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugalska |

Laboratórios BIAL

Portela & Ca, S.A.

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugalska

Noprilam

500/125 mg

Obložena tableta

Peroralna uporaba

Noprilam DT

875/125 mg

Obložena tableta

Peroralna uporaba

Noprilam DT

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400/57 mg/5 ml

Nizozemska

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NIZOZEMSKA |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NIZOZEMSKA

Augmentin

250/25 mg

Prašek za injiciranje

Intravenska uporaba

250 mg: 25 mg/5,2 ml

Augmentin

500/50 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 50 mg/10,5 ml

Augmentin

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin

1 000/100 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 100 mg/20,9 ml

Augmentin

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg: 200 mg/120 ml

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

100/12,5 mg/ml

Prašek za peroralno suspenzijo

Peroralna uporaba

100 mg: 12,5 mg/ml

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

| Glaxo Smith Kline B.V. |
| --- |
| Huis ter Heideweg 62 |
| 3705 LZ ZEIST |
| NIZOZEMSKA |

Glaxo Smith Kline B.V.

Huis ter Heideweg 62

3705 LZ ZEIST

NIZOZEMSKA

amoxicilline/clavulaanzuur

250/62,5 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Poljska

| GlaxoSmithKline Export Ltd |
| --- |
| 980 Great West Road |
| Brentford, Middlesex, TW8 9GS |
| VB |

GlaxoSmithKline Export Ltd

980 Great West Road

Brentford, Middlesex, TW8 9GS

VB

Augmentin

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg: 200 mg/120 ml

Augmentin

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Portugalska

| 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

Filmsko obložena tableta

Peroralna uporaba

Augmentin Duo

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin Forte

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin Duo

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

| Bial - Portela & Ca, S.A |
| --- |
| À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado |
| Portugalska |

Bial - Portela & Ca, S.A

À Av. da Siderurgia Nacional – 4745-457 S. Mamede do Coronado

Portugalska

Clavamox 125

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Clavamox 250

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Clavamox 500

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavamox DT

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavamox DT 400

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Clavamox ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Noprilam

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Noprilam

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Noprilam

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Noprilam DT

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

| 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

Filmsko obložena tableta

Peroralna uporaba

Penilan

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Penilan DT

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Penilan Forte

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Romunija

| Beecham Group PLC |
| --- |
| 980 Great West Road, Brentford, Middlesex TW8 9GS |
| Velika Britanija |

Beecham Group PLC

980 Great West Road, Brentford, Middlesex TW8 9GS

Velika Britanija

Augmentin

intravenos 1,2 g

1 000/200 mg

Prašek za injiciranje/infundiranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin

Intravenos 2,2 g

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg: 200 mg/120 ml

Augmentin 625 mg

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 1 g

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin BIS

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Filmsko obložena tableta s podaljšanim sproščanjem

Peroralna uporaba

Slovaška

GlaxoSmithKline Slovakia sro., Galvaniho7/A, 82104 Bratislava, Slovaška.

Augmentin 375 mg

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 625 mg

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 1 g

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin DUO

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Augmentin ES

600/42,9 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

600 mg: 42,9 mg/5 ml

Augmentin SR

1 000/62,5 mg

Tableta s podaljšanim sproščanjem

Peroralna uporaba

Slovenija

| GSK d.o.o., Ljubljana |
| --- |
| Knezov štradon 90 |
| SI-1000 Ljubljana |
| Slovenija |

GSK d.o.o., Ljubljana

Knezov štradon 90

SI-1000 Ljubljana

Slovenija

Augmentin 0,6 g prašek za raztopino za injiciranje ali infundiranje

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin 1,2 g prašek za raztopino za injiciranje ali infundiranje

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin 625 mg filmsko obložene tablete

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 1 000 mg filmsko obložene tablete

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 457 mg/5 ml prašek za peroralno suspenzijo

400/57 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

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

Filmsko obložena tableta

Peroralna uporaba

Španija

| 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

Prašek za injiciranje

Intravenska uporaba

500 mg: 50 mg/10,5 ml

Augmentine Intravenoso

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000mg: 200 mg/20,9 ml

Augmentine Intravenoso

2 000/200 mg

Prašek za infundiranje

Intravenska uporaba

2 000 mg: 200 mg/120 ml

Augmentine

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentine

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentine

100/12,5 mg/ml

Prašek za peroralno suspenzijo

Peroralna uporaba

100 mg: 12,5 mg/ml

Augmentine

500/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentine

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentine Plus

1 000/62,5 mg

Filmsko obložena tableta

Peroralna uporaba

| 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

Prašek za peroralno suspenzijo

Peroralna uporaba

Pangamox

500/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Pangamox

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

| 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

Filmsko obložena tableta

Peroralna uporaba

Clavumox

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavumox

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Clavumox

125/31,25 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Clavumox

250/62,5 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Clavepen

500/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Clavumox

500/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Clavumox

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Amoxicilina/Ác. Clavulanico ALLEN

875/125 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Švedska

| Meda AB |
| --- |
| Box 906 |
| 170 09 Sverige (SWE) |
| Švedska |

Meda AB

Box 906

170 09 Sverige (SWE)

Švedska

Spektramox

250/125 mg

(Amoxicillin: 250 mg)

Filmsko obložena tableta

Peroralna uporaba

Spektramox

500/125 mg

(Amoxicillin: 500 mg)

Filmsko obložena tableta

Peroralna uporaba

Spektramox

875/125 mg

(Amoxicillin 875 mg)

Filmsko obložena tableta

Peroralna uporaba

Spektramox

125/31,25 mg/5 ml

(Amoxicillin 25 mg/ml)

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Spektramox

125/31,25 mg

(Amoxicillin: 125 mg)

Prašek za peroralno suspenzijo

Peroralna uporaba

Spektramox

250/62,5 mg/5 ml

(Amoxicillin: 50 mg/ml)

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Spektramox

400/57 mg/5 ml

(Amoxicillin: 80 mg/ml)

Prašek za peroralno suspenzijo

Peroralna uporaba

400 mg: 57 mg/5 ml

Velika Britanija

| Beecham Group PLC |
| --- |
| SB House |
| Great West Road |
| Brentford |
| Middlesex TW8 9GS |
| Velika Britanija |

Beecham Group PLC

SB House

Great West Road

Brentford

Middlesex TW8 9GS

Velika Britanija

Augmentin Intravenous 600 mg & 1,2 gm

500/100 mg

Prašek za injiciranje

Intravenska uporaba

500 mg: 100 mg/10,5 ml

Augmentin Intravenous 600 mg & 1,2 gm

1 000/200 mg

Prašek za injiciranje

Intravenska uporaba

1 000 mg: 200 mg/20,9 ml

Augmentin 375 mg Tablets

250/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 375 mg dispersible tablets

250/125 mg

Disperzibilna tableta

Peroralna uporaba

Augmentin 1 g Tablets

875/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 625 mg Tablets

500/125 mg

Filmsko obložena tableta

Peroralna uporaba

Augmentin 250/62 SF Suspension

250/62,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

250 mg: 62,5 mg/5 ml

Augmentin 125/31 SF Sachet

125/31,25 mg

Prašek za peroralno suspenzijo

Peroralna uporaba

Augmentin 125/31 SF Suspension

125/31,25 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

125 mg: 31,25 mg/5 ml

Augmentin Duo

200/28,5 mg/5 ml

Prašek za peroralno suspenzijo

Peroralna uporaba

200 mg: 28,5 mg/5 ml

---

DODATEK XI

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- |
| Danska | STADA Arzneimittel AG Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

Država članica

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Danska

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentrans Depotplaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Nemčija

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl-GRY

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

---

DODATEK XII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- |
| Danska | STADA Arzneimittel AG |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

Država članica

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Danska

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Matripain Depotplaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Nemčija

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl AL

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

---

DODATEK XIII

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV IN IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | | Teva Pharma B.V. |
| 3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217 |
| Nizozemska |

Država članica

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Teva Pharma B.V.

3640 AE Mijdrecht, Industrieweg 23, P.O. Box 217

Nizozemska

Fentanyl TEVA transdermales Pflaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Belgija

| TEVA Pharma Belgium N.V |
| --- |
| B-2610 Wilrijk; Laarstraat 16 |
| Belgija |

TEVA Pharma Belgium N.V

B-2610 Wilrijk; Laarstraat 16

Belgija

Fentanyl TEVA Pleister voor transdermaal gebruik

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Češka republika

| Teva Pharmaceuticals CR, s.r.o. |
| --- |
| Radlická 3185/1C |
| Praha 5 |
| Češka republika |

Teva Pharmaceuticals CR, s.r.o.

Radlická 3185/1C

Praha 5

Češka republika

Fentanyl - TEVA

25 μg/h

25 μg/h

Transdermalni obliž

Transdermalna uporaba

Fentanyl - TEVA

50 μg/h

50 μg/h

Fentanyl - TEVA

75 μg/h

75 μg/h

Fentanyl - TEVA

100 μg/h

100 μg/h

Danska

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18, |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG

Stadastrasse 2-18,

61118 Bad Vilbel

Nemčija

Matrigesic Depotplaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Estonija

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| Nizozemska |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

Nizozemska

Fentanyl - TEVA transdermalpatch

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Finska

| TEVA Sweden AB |
| --- |
| PO Box 1070 |
| 251 10 Helsingborg, |
| Švedska |

TEVA Sweden AB

PO Box 1070

251 10 Helsingborg,

Švedska

Fentanyl TEVA

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Francija

| Société TEVA CLASSICS Immeuble Le Palatin 1 |
| --- |
| 1, Cours du Triangle; 92936 Paris La Défense Cedex |
| Francija |

Société TEVA CLASSICS Immeuble Le Palatin 1

1, Cours du Triangle; 92936 Paris La Défense Cedex

Francija

Fentanyl TEVA dispositif transdermique

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Madžarska

| TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest |
| --- |
| Madžarska |

TEVA Magyarország Rt. Rákóczi út. 70- 72, H-1074 Budapest

Madžarska

Fentanyl – Teva tapasz

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Italija

| TEVA Pharma Italia S.r.l. |
| --- |
| Via Giulio Richard, 7 20143 Milan |
| Italija |

TEVA Pharma Italia S.r.l.

Via Giulio Richard, 7 20143 Milan

Italija

Fentanil Teva cerotti transdermici

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Latvija

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| Nizozemska |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

Nizozemska

Fentanyl - TEVA transdermālie plāksteri

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Litva

| Teva Pharmaceuticals Europe B.V. |
| --- |
| Industrieweg 23, 3641 RK Mijdrecht |
| Nizozemska |

Teva Pharmaceuticals Europe B.V.

Industrieweg 23, 3641 RK Mijdrecht

Nizozemska

Fentanyl - TEVA

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Luksemburg

| TEVA Pharma Belgium N.V |
| --- |
| B-2610 Wilrijk; Laarstraat 16 |
| Belgija |

TEVA Pharma Belgium N.V

B-2610 Wilrijk; Laarstraat 16

Belgija

Fentanyl TEVA Dispositif transdermique

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Nizozemska

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl 25 microgram/uur PCH, pleister voor transdermaal gebruik

25 μg/h

Transdermalni obliž

Transdermalna uporaba

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

Norveška

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg |
| Švedska |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg

Švedska

Fentanyl TEVA

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Poljska

| TEVA PHARMACEUTICALS Polska Sp. Z.o.o. |
| --- |
| Emilii Plater 53, 00-113 |
| Warsaw |
| Poljska |

TEVA PHARMACEUTICALS Polska Sp. Z.o.o.

Emilii Plater 53, 00-113

Warsaw

Poljska

Fentanyl TEVA system transdermalny

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Portugalska

| Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo |
| --- |
| Portugalska |

Teva Pharma - Produtos Farmaceuticos, Lda Lagoas Park, Edifício 1, Piso 3, 2740 - 264 Porto Salvo

Portugalska

Fentanilo Teva

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Slovaška

| Teva Pharmaceuticals CR, s.r.o |
| --- |
| Drazni 7; |
| 627 00 Brno |
| Czech Republic |

Teva Pharmaceuticals CR, s.r.o

Drazni 7;

627 00 Brno

Czech Republic

Fentanyl – TEVA

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Slovenija

| Teva Pharmaceuticals Europe B.V. |
| --- |
| 3641 RK Mijdrecht, Indrustrieweg 23 |
| Nizozemska |

Teva Pharmaceuticals Europe B.V.

3641 RK Mijdrecht, Indrustrieweg 23

Nizozemska

Fentanil TEVA transdermalni obliž

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Španija

| TEVA GENERICOS ESPAÑOLA, S.L. |
| --- |
| Guzman el Bueno; 133. Edif. Britannia |
| 28003 Madrid |
| Španija |

TEVA GENERICOS ESPAÑOLA, S.L.

Guzman el Bueno; 133. Edif. Britannia

28003 Madrid

Španija

Fentanilo TEVA parches transdermicos EFG

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Švedska

| TEVA Sweden AB |
| --- |
| PO Box 1070; |
| 251 10 Helsingborg, |
| Švedska |

TEVA Sweden AB

PO Box 1070;

251 10 Helsingborg,

Švedska

Matrigesic Transdermalni obliž

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Združeno kraljestvo

| TEVA UK Limited |
| --- |
| Brampton Road; Hampden Park; Eastbourne; East Sussex |
| BN22 9AG |
| Združeno kraljestvo |

TEVA UK Limited

Brampton Road; Hampden Park; Eastbourne; East Sussex

BN22 9AG

Združeno kraljestvo

Fentanyl Transdermalni obliž

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

---

DODATEK XIV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV, IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- | --- |
| Danska | STADA Arzneimittel AG |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

Država članica

Imetnik dovoljenja za promet z zdravilom

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Danska

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentador

Depotplaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Nemčija

| STADA Arzneimittel AG |
| --- |
| Stadastrasse 2-18 |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentador

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

---

DODATEK XV

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL, POTI UPORABE, PREDLAGATELJEV/IMETNIKOV DOVOLJENJA ZA PROMET TER IMETNIKOV DOVOLJENJA ZA PROMET Z ZDRAVILOM V DRŽAVAH ČLANICAH

| Država članica | Imetnik dovoljenja za promet z zdravilom | Predlagatelj/Imetnik dovoljenja za promet z zdravilom | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- | --- |
| Avstrija | | STADA Arzneimittel GmbH |
| Muthgasse 36/2 |
| 1190 Wien |
| Avstrija |

Država članica

Imetnik dovoljenja za promet z zdravilom

Predlagatelj/Imetnik dovoljenja za promet z zdravilom

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

Avstrija

STADA Arzneimittel GmbH

Muthgasse 36/2

1190 Wien

Avstrija

Fentanyl STADA Depotpflaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Belgija

| Eurogenerics N.V., Heizel Esplanade Heysel b22 |
| --- |
| 1020 Brussels |
| Belgija |

Eurogenerics N.V., Heizel Esplanade Heysel b22

1020 Brussels

Belgija

Fentanyl EG Pleister voor transdermaal gebruik

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Češka republika

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl STADA

25 μg/h

25 μg/h

Transdermalni obliž

Transdermalna uporaba

Fentanyl STADA

50 μg/h

50 μg/h

Fentanyl STADA

75 μg/h

75 μg/h

Fentanyl STADA

100 μg/h

100 μg/h

Danska

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentastad depotplaster

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Estonija

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentaderm transdermal patch

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Finska

| STADA Arzneimittel AG Stadastrasse 2-18, |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18,

61118 Bad Vilbel

Nemčija

Fentanyl STADA

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Francija

| EGLABO |
| --- |
| Le Quintet-Bat A |
| 12 rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| Francija |

EGLABO

Le Quintet-Bat A

12 rue Danjou

92517 Boulogne Billancourt Cedex

Francija

Fentanyl EG LABO, dispositif transdermique

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Madžarska

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl STADA tapasz

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Italija

| EG S.p.A. |
| --- |
| Via D. Scarlatti, 31 |
| 20124 Milano |
| Italija |

EG S.p.A.

Via D. Scarlatti, 31

20124 Milano

Italija

Nilafen cerotti transdermici

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Latvija

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentastad transdermālie plāksteri

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Litva

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentaderm

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Luksemburg

| Eurogenerics N.V., Heizel Esplanade Heysel b22, |
| --- |
| 1020 Brussels |
| Belgija |

Eurogenerics N.V., Heizel Esplanade Heysel b22,

1020 Brussels

Belgija

Fentanyl EG pleister voor transdermal gebruik

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Nizozemska

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl CF 25 microgram/uur, pleister voor transdermaal gebruik

25 μg/h

Transdermalni obliž

Transdermalna uporaba

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

Poljska

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl STADA

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Portugalska

| Ciclum Farma Unipessoal, Lda. |
| --- |
| Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos |
| Portugalska |

Ciclum Farma Unipessoal, Lda.

Quinta da Fonte, Rua Vitor Câmara, no 2, Edifício D. Amélia - Piso 1, Ala B, 2770-229 Paço de Arcos

Portugalska

Fentanilo Ciclum

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Slovaška

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl STADA transdermálna náplasť

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Španija

| Lab. STADA |
| --- |
| Frederic Mompou,5 |
| 08960 Sant Just Desvern, Barcelona |
| Španija |

Lab. STADA

Frederic Mompou,5

08960 Sant Just Desvern, Barcelona

Španija

Fentanilo STADA parches transdermicos EFG

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Švedska

| STADA Arzneimittel AG Stadastrasse 2-18 |
| --- |
| 61118 Bad Vilbel |
| Nemčija |

STADA Arzneimittel AG Stadastrasse 2-18

61118 Bad Vilbel

Nemčija

Fentanyl STADA transdermal patch

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

Velika Britanija

| Genus Pharmaceuticals Ltd. |
| --- |
| (posluje kot Genus Pharmaceuticals) |
| Benham, Valence, Newbury |
| Berkshire, RG20 8LU |
| Velika Britanija |

Genus Pharmaceuticals Ltd.

(posluje kot Genus Pharmaceuticals)

Benham, Valence, Newbury

Berkshire, RG20 8LU

Velika Britanija

Fentanyl Transdermal Patch

25 μg/h

Transdermalni obliž

Transdermalna uporaba

50 μg/h

75 μg/h

100 μg/h

---