# Uradni list C 184/2013

| | ISSN 1977-1045
  doi:10.3000/19771045.C_2013.184.slv |
| --- | --- |
| Uradni list
  Evropske unije | C 184 |
| | |
| Slovenska izdaja | Informacije in objave | Zvezek 5628. junij 2013 |

ISSN 1977-1045

doi:10.3000/19771045.C_2013.184.slv

Uradni list

Evropske unije

C 184

Slovenska izdaja

Informacije in objave

Zvezek 5628. junij 2013

---

| Obvestilo št. | Vsebina | Stran |
| --- | --- | --- |
| | IV   Informacije |
| | INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
| | Evropska komisija |
| 2013/C 184/01 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2013 do 31. maja 2013(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta) | 1 |
| 2013/C 184/02 | Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2013 do 31. maja 2013(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  ali člena 38 Direktive 2001/82/ES
  ) | 10 |

Obvestilo št.

Vsebina

Stran

IV   Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

2013/C 184/01

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2013 do 31. maja 2013(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

2013/C 184/02

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2013 do 31. maja 2013(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
  ali člena 38 Direktive 2001/82/ES
  )

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES

ali člena 38 Direktive 2001/82/ES

)

10

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

SL

---

IV Informacije

INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE

Evropska komisija

| 28.6.2013 | SL | Uradni list Evropske unije | C 184/1 |
| --- | --- | --- | --- |

28.6.2013

SL

Uradni list Evropske unije

C 184/1

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2013 do 31. maja 2013

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

2013/C 184/01

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

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.5.2013 | HyQvia | Humani polispecifični imunoglobulin | Baxter Innovations GmbH |
| Industriestraße 67, A-1221 Wien, Österreich |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

16.5.2013

HyQvia

Humani polispecifični imunoglobulin

Baxter Innovations GmbH

Industriestraße 67, A-1221 Wien, Österreich

EU/1/13/840

Raztopina za infundiranje

J06BA

22.5.2013

16.5.2013

Vorikonazol Accord

vorikonazol

| Accord Healthcare Limited |
| --- |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom |

Accord Healthcare Limited

Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom

EU/1/13/835

Filmsko obložene tablete

J02AC03

22.5.2013

24.5.2013

Stribild

elvitegravir/kobicistat/emtricitabin/tenofovirdizoproksilat (v obliki tenofovirdizoproksilata fumarata)

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

Filmsko obložene tablete

J05AR09

27.5.2013

—   Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Zavrnjena

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Qsiva | VIVUS BV |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

14.5.2013

Qsiva

VIVUS BV

Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland

—

16.5.2013

29.5.2013

Kynamro

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

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

—

31.5.2013

31.5.2013

Raxone

| Santhera Pharmaceuticals (Deutschland) GmbH |
| --- |
| Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland |

Santhera Pharmaceuticals (Deutschland) GmbH

Wallbrunnstrasse 24, D-79539 Lörrach, Deutschland

—

4.6.2013

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

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 3.5.2013 | Nevanac | Alcon Laboratories (UK) Ltd. |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

3.5.2013

Nevanac

Alcon Laboratories (UK) Ltd.

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/07/433

7.5.2013

3.5.2013

Votrient

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

Glaxo Group Limited

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

EU/1/10/628

7.5.2013

6.5.2013

Vibativ

| Theravance UK Limited |
| --- |
| 90 Fetter Lane, London EC4A 1EQ, United Kingdom |

Theravance UK Limited

90 Fetter Lane, London EC4A 1EQ, United Kingdom

EU/1/11/705

8.5.2013

14.5.2013

Hepsera

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/251

16.5.2013

14.5.2013

Olanzapine Cipla

| Cipla (EU) Limited |
| --- |
| Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom |

Cipla (EU) Limited

Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom

EU/1/07/426

16.5.2013

16.5.2013

Ozurdex

| Allergan Pharmaceuticals Ireland, (514125) |
| --- |
| Castlebar Road, Westport, County Mayo, Ireland |

Allergan Pharmaceuticals Ireland, (514125)

Castlebar Road, Westport, County Mayo, Ireland

EU/1/10/638

22.5.2013

16.5.2013

Xagrid

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

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

22.5.2013

22.5.2013

Adcirca

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/476

24.5.2013

22.5.2013

Aloxi

| Helsinn Birex Pharmaceuticals Ltd |
| --- |
| Damastown, Mulhuddart, Dublin 15, Ireland |

Helsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Ireland

EU/1/04/306

27.5.2013

22.5.2013

Leganto

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

27.5.2013

22.5.2013

Olanzapine Mylan

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

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/08/475

24.5.2013

22.5.2013

Xarelto

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

24.5.2013

23.5.2013

Trizivir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/00/156

28.5.2013

27.5.2013

Afinitor

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

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/538

29.5.2013

27.5.2013

Avastin

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

Roche Registration Limited

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

EU/1/04/300

29.5.2013

27.5.2013

Combivir

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/98/058

29.5.2013

27.5.2013

DuoCover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

29.5.2013

27.5.2013

Incivo

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

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

29.5.2013

27.5.2013

Ixiaro

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

Intercell Austria AG

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

29.5.2013

27.5.2013

Kivexa

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

ViiV Healthcare UK Limited

980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/04/298

29.5.2013

27.5.2013

Neupro

| UCB Manufacturing Ireland Ltd. |
| --- |
| Shannon Industrial Estate, Co, Clare, Ireland |

UCB Manufacturing Ireland Ltd.

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

29.5.2013

27.5.2013

PANTECTA Control

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

Takeda GmbH

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

EU/1/09/518

29.5.2013

27.5.2013

PANTOLOC Control

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

Takeda GmbH

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

EU/1/09/519

29.5.2013

27.5.2013

Relistor

| TMC Pharma Services Ltd. |
| --- |
| Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom |

TMC Pharma Services Ltd.

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/08/463

29.5.2013

27.5.2013

Samsca

| Otsuka Pharmaceutical Europe Ltd |
| --- |
| Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. |

Otsuka Pharmaceutical Europe Ltd

Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom.

EU/1/09/539

29.5.2013

27.5.2013

Zometa

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

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/01/176

29.5.2013

27.5.2013

Zypadhera

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/479

29.5.2013

27.5.2013

Zyprexa

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/96/022

29.5.2013

27.5.2013

Zyprexa Velotab

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

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/99/125

29.5.2013

29.5.2013

Pritor

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/089

31.5.2013

29.5.2013

PritorPlus

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

31.5.2013

30.5.2013

Clopidogrel Zentiva

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/08/465

3.6.2013

30.5.2013

CONTROLOC Control

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

Takeda GmbH

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

EU/1/09/515

3.6.2013

30.5.2013

DuoPlavin

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

3.6.2013

30.5.2013

Epivir

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

ViiV Healthcare UK Limited

980 Great West Road,

Brentford, Middlesex TW8 9GS, United Kingdom

EU/1/96/015

3.6.2013

30.5.2013

Iscover

| Sanofi-Aventis groupe |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/070

3.6.2013

30.5.2013

Kinzalkomb

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

3.6.2013

30.5.2013

Kinzalmono

| Bayer Pharma AG |
| --- |
| D-13342 Berlin, Deutschland |

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091

3.6.2013

30.5.2013

Micardis

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

Boehringer Ingelheim International GmbH

Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/98/090

3.6.2013

30.5.2013

MicardisPlus

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

Boehringer Ingelheim International GmbH

Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland

EU/1/02/213

3.6.2013

30.5.2013

PANTOZOL Control

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

Takeda GmbH

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

EU/1/09/517

3.6.2013

30.5.2013

PegIntron

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/131

3.6.2013

30.5.2013

Plavix

| Sanofi Pharma Bristol-Myers Squibb SNC |
| --- |
| 54 rue La Boétie, F-75008 Paris, France |

Sanofi Pharma Bristol-Myers Squibb SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

3.6.2013

30.5.2013

RoActemra

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

Roche Registration Limited

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

EU/1/08/492

3.6.2013

30.5.2013

SOMAC Control

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

Takeda GmbH

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

EU/1/09/516

3.6.2013

30.5.2013

ViraferonPeg

| Merck Sharp & Dohme Limited |
| --- |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/00/132

3.6.2013

31.5.2013

Imatinib Teva

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

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/808

4.6.2013

—   Izdaja dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta
   (2)
  ): Odobrena

| Datum sprejetja sklepa | Ime zdravila | INN (mednarodno nelastniško ime) | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Farmacevtska oblika | ATC (anatomsko terapevtska kemijska oznaka) | Datum obvestila |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.5.2013 | Oncept IL-2 | Rekombinantni pox virus kanarčkov (vCP1338), ki vsebuje mačji interleukin-2 | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Datum sprejetja sklepa

Ime zdravila

INN (mednarodno nelastniško ime)

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Farmacevtska oblika

ATC (anatomsko terapevtska kemijska oznaka)

Datum obvestila

3.5.2013

Oncept IL-2

Rekombinantni pox virus kanarčkov (vCP1338), ki vsebuje mačji interleukin-2

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/150

Liofilizat in topilo - vbrizgljiva suspenzija

QL03AX

7.5.2013

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

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 6.5.2013 | BTVPUR AlSap 1 | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

6.5.2013

BTVPUR AlSap 1

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/112

13.5.2013

6.5.2013

BTVPUR AlSap 1-8

| Merial |
| --- |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/113

13.5.2013

14.5.2013

Cerenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/062

16.5.2013

14.5.2013

Posatex

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

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/08/081

16.5.2013

16.5.2013

Convenia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/06/059

22.5.2013

16.5.2013

Suvaxyn PCV

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/099

22.5.2013

16.5.2013

Zulvac 1 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/131

22.5.2013

16.5.2013

Zulvac 8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/104

22.5.2013

22.5.2013

Draxxin

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/03/041

24.5.2013

22.5.2013

Improvac

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/095

25.5.2013

22.5.2013

Pirsue

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/00/027

24.5.2013

22.5.2013

Poulvac E. coli

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/12/140

24.5.2013

22.5.2013

Quadrisol

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/97/005

24.5.2013

22.5.2013

Stronghold

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/99/014

24.5.2013

22.5.2013

Zulvac 1+8 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/12/139

24.5.2013

22.5.2013

Zulvac 1 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/130

24.5.2013

22.5.2013

Zulvac 8 Bovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/105

24.5.2013

23.5.2013

Naxcel

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/05/053

27.5.2013

23.5.2013

TruScient

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/136

27.5.2013

27.5.2013

Equip WNV

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/08/086

29.5.2013

27.5.2013

Fevaxyn Pentofel

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/96/002

29.5.2013

27.5.2013

Palladia

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/09/100

29.5.2013

27.5.2013

Slentrol

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/07/071

29.5.2013

27.5.2013

Zulvac 1+8 Ovis

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/11/120

29.5.2013

30.5.2013

Trocoxil

| Zoetis Belgium S.A. |
| --- |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique

EU/2/08/084

3.6.2013

—   Ukinitev dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Registracijska številka v registru Skupnosti | Datum obvestila |
| --- | --- | --- | --- | --- |
| 22.5.2013 | Nobivac Piro | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/04/046 | 24.5.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Registracijska številka v registru Skupnosti

Datum obvestila

22.5.2013

Nobivac Piro

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/04/046

24.5.2013

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

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

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK-LONDON E14 4H

---

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

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

---

| 28.6.2013 | SL | Uradni list Evropske unije | C 184/10 |
| --- | --- | --- | --- |

28.6.2013

SL

Uradni list Evropske unije

C 184/10

---

Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. maja 2013 do 31. maja 2013

(Sklepi, sprejeti na podlagi člena 34 Direktive 2001/83/ES
   (1)
  ali člena 38 Direktive 2001/82/ES
   (2)
  )

2013/C 184/02

—   Izdaja, ohranjanje ali sprememba nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 16.5.2013 | Nuflor Swine Once 450 mg/ml | Glej Prilogo I | Glej Prilogo I | 21.5.2013 |
| 27.5.2013 | Simvastatin Vale and associated names | Glej Prilogo II | Glej Prilogo II | 28.5.2013 |
| 23.5.2013 | Florgane | Glej Prilogo III | Glej Prilogo III | 24.5.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

16.5.2013

Nuflor Swine Once 450 mg/ml

Glej Prilogo I

Glej Prilogo I

21.5.2013

27.5.2013

Simvastatin Vale and associated names

Glej Prilogo II

Glej Prilogo II

28.5.2013

23.5.2013

Florgane

Glej Prilogo III

Glej Prilogo III

24.5.2013

—   Zavrnitev izdaje nacionalnega dovoljenja za promet z zdravili

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Furosemide | Glej Prilogo IV | Glej Prilogo IV | 15.5.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

14.5.2013

Furosemide

Glej Prilogo IV

Glej Prilogo IV

15.5.2013

—   Umik nacionalnega dovoljenja za promet

| Datum sprejetja sklepa | Ime zdravila | Imetnik dovoljenja za promet | Zadevna država članica | Datum obvestila |
| --- | --- | --- | --- | --- |
| 29.5.2013 | Tetrazepam | Glej Prilogo V | Glej Prilogo V | 29.5.2013 |

Datum sprejetja sklepa

Ime zdravila

Imetnik dovoljenja za promet

Zadevna država članica

Datum obvestila

29.5.2013

Tetrazepam

Glej Prilogo V

Glej Prilogo V

29.5.2013

---

(1)  UL L 311, 28.11.2001, str. 67.

(2)  UL L 311, 28.11.2001, str. 1.

---

PRILOGA I

SEZNAM IMEN, FARMACEVTSKA OBLIKA, JAKOST ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI, CILJNA ŽIVALSKA VRSTA, NAČIN UPORABE, PREDLAGATELJ V DRŽAVI ČLANICI

| Država članica
  EU/EEA | Predlagatelj | Ime zdravila | Izmišljeno ime | Farmacevtska oblika | Jakost | Ciljna živalska vrsta | Način uporabe |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austrija (1) | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Država članica

EU/EEA

Predlagatelj

Ime zdravila

Izmišljeno ime

Farmacevtska oblika

Jakost

Ciljna živalska vrsta

Način uporabe

Austrija (1)

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Belgija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Bulgarija (1)

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Ciper

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Češka

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Danska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

PigFlor Once

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Estonija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Francija (1)

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Nemčija (1)

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Grčija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Madžarska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Irska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Italija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

NUFLOR Suini One, 450 mg/ml soluzione iniettabile per suini

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Latvija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Litva

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Luksemburg

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Malta

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Nizozemska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Poljska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Portugalska

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Romunija (1)

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Slovaška

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Slovenija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Španija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Flomac porcino dosis única 450 mg/ml solución inyectable

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

Velika Britanija

| Intervet International B.V. |
| --- |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Nizozemska |

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Nizozemska

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Raztopina za injiciranje

450 mg/ml

Prašiči

Intramuskularno

---

(1)  Marketing authorisation granted

---

PRILOGA II

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVILA, POTI UPORABE ZDRAVILA, PREDLAGATELJEV V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Pot uporabe |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Vale Pharmaceuticals Limited |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Država članica

EU/EGP

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Pot uporabe

Avstrija

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 20 mg/5 ml Suspension zum Einnehmen

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Avstrija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 40 mg/5 ml Suspension zum Einnehmen

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Danska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Danska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Finska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Finska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Francija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Francija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Nemčija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Nemčija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Grčija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Grčija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Irska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Irska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Italija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatina Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Italija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatina Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Nizozemska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatine Vale Pharmaceuticals 20 mg/5 ml suspensie voor oraal gebruik

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Nizozemska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatine Vale Pharmaceuticals 40 mg/5 ml suspensie voor oraal gebruik

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Norveška

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Norveška

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Portugalska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Sinvastatina Vale

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Portugalska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Sinvastatina Vale

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Španija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 20 mg/5 ml suspensión oral

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Španija

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale 40 mg/5 ml suspensión oral

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Švedska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Švedska

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Združeno kraljestvo

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

20 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

Združeno kraljestvo

| Vale Pharmaceuticals Limited |
| --- |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Vale Pharmaceuticals Limited

1b Gurtnafleur Business Park Gurtnafleur, Clonmel

Co. Tipperary

Ireland

Simvastatin Vale Pharmaceuticals

40 mg/5 ml

Peroralna suspenzija

Peroralna uporaba

---

PRILOGA III

SEZNAM IMEN, FARMACEVTSKIH OBLIK, JAKOSTI ZDRAVIL ZA UPORABO V VETERINARSKI MEDICINI, ŽIVALSKIH VRST, POTI UPORABE ZDRAVILA IN PREDLAGATELJEV V DRŽAVAH ČLANICAH

| Država članica
  EU/EGP | Predlagatelj | Ime | Mednarodno nelastniško ime | Farmacevtska oblika | Jakost | Živalska vrsta | Pot |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Avstrija | Emdoka bvba |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Država članica

EU/EGP

Predlagatelj

Ime

Mednarodno nelastniško ime

Farmacevtska oblika

Jakost

Živalska vrsta

Pot

Avstrija

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Belgija

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspensie voor injectie voor runderen en varkens/suspension injectable pour bovins et porcs

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Bolgariji

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml инжекционна суспензия за говеда и прасета

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Češka republika

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml injekční suspenze pro skot a prasata

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Danska

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml, injektionsvæske, suspension til kvæg og svin

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Francija (1)

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspension injectable pour bovins et porcins

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Nemčija (1)

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Grčiji

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml Ενέσιμο εναιώρημα για Βοοειδή και χοίρους

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Madžarska

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml injekció szarvasmarha és sertés részére A.U.V.

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Irska

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspension for injection for cattle and pigs

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Italija

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml sospensione iniettabile per bovini e suini

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Litva

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml injekcinė suspensija galvijams ir kiaulėms

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Luksemburg

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 Mg/Ml suspension injectable pour bovins et porcins

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Nizozemska

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspensie voor injectie voor runderen en varkens

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Poljska

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml, zawiesina do wstrzykiwań dla bydła i świń

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Portugalski

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspensão injectável para bovinos e suínos

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Romunija

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspensie injectabilă pentru bovine și porcine

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Slovaška republika

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml injekčná suspenzia pre hovädzí dobytok a ošípané

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Španija (1)

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspensión inyectable para bovino y porcino

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

Združeno kraljestvo

| Emdoka bvba |
| --- |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgija |

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgija

Florgane 300 mg/ml suspension for injection for cattle and pigs

florfenicol

Suspenzija za injiciranje

300 mg/ml

Govedo, Prašiče

Intramuskularna uporaba

---

(1)  Dovoljenje za promet z zdravilom odobreno

---

PRILOGA IV

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

| Država članica
  EU/EGP | Predlagatelj | (Izmišljeno) ime | Jakost | Farmacevtska oblika | Način uporabe |
| --- | --- | --- | --- | --- | --- |
| Češka republika | Vitabalans Oy Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Država članica

EU/EGP

Predlagatelj

(Izmišljeno) ime

Jakost

Farmacevtska oblika

Način uporabe

Češka republika

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tablety

40 mg

tableta

peroralna uporaba

Danski

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

Estoniji

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

Finski

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

Madžarski

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans

40 mg

tableta

peroralna uporaba

Latviji

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tabletes

40 mg

tableta

peroralna uporaba

Litvo

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

Norveško

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

Poljsko

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

Slovaška

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablety

40 mg

tableta

peroralna uporaba

Slovenija

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablete

40 mg

tableta

peroralna uporaba

Švedska

| Vitabalans Oy Varastokatu 8 |
| --- |
| 13500 Hämeenlinna |
| Finland |

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tableta

peroralna uporaba

---

PRILOGA V

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

| Država članica EU/EGP | Imetnik dovoljenja za promet z zdravilom | Izmišljeno ime Ime | Jakost | Farmacevtska oblika | Pot uporabe zdravila |
| --- | --- | --- | --- | --- | --- |
| Avstrija | Sanofi-Aventis GmbH |
| Leonard-Bernstein-Str. 10 |
| Vienna DC |
| A-1220 Vienna |
| Austria |

Država članica EU/EGP

Imetnik dovoljenja za promet z zdravilom

Izmišljeno ime Ime

Jakost

Farmacevtska oblika

Pot uporabe zdravila

Avstrija

Sanofi-Aventis GmbH

Leonard-Bernstein-Str. 10

Vienna DC

A-1220 Vienna

Austria

Myolastan 50 mg - Filmtabletten

50 mg

Filmsko obložena tableta

Peroralna uporaba

Avstrija

| MIP Pharma GmbH |
| --- |
| Kirkeler Straße 41 |
| D-66440 Blieskastel-Niederwürzbach |
| Germany |

MIP Pharma GmbH

Kirkeler Straße 41

D-66440 Blieskastel-Niederwürzbach

Germany

Tetrazepam-MIP 50 mg Tabletten

50 mg

Tableta

Peroralna uporaba

Belgium

| Will Pharma S.A. |
| --- |
| Monplaisirlaan 33 |
| B-1030 Brussel |
| Belgium |

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Filmsko obložena tableta

Peroralna uporaba

Belgija

| Sanofi Aventis Belgium N.V |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Filmsko obložena tableta

Peroralna uporaba

Belgija

| Eurogenerics NV |
| --- |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Filmsko obložena tableta

Peroralna uporaba

Bolgarija

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP

50 mg

Tableta

Peroralna uporaba

Češka

| Sanofi-Aventis, s.r.o. |
| --- |
| Evropská 846/176a |
| Praha 6 - Vokovice, 160 00 |
| Czech Republic |

Sanofi-Aventis, s.r.o.

Evropská 846/176a

Praha 6 - Vokovice, 160 00

Czech Republic

MYOLASTAN

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

MYOLASTAN 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Daiichi Sankyo France SAS |
| --- |
| Immeuble le Corosa |
| 1, rue Eugene et Armand Peugeot |
| 92508 Rueil Malmaison |
| France |

Daiichi Sankyo France SAS

Immeuble le Corosa

1, rue Eugene et Armand Peugeot

92508 Rueil Malmaison

France

PANOS 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Sandoz |
| --- |
| 49, avenue Georges Pompidou |
| 92300 Levallois-Perret |
| France |

Sandoz

49, avenue Georges Pompidou

92300 Levallois-Perret

France

TETRAZEPAM SANDOZ 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Zydus France |
| --- |
| 25, rue des Peupliers |
| ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers |
| 923752 Nanterre |
| France |

Zydus France

25, rue des Peupliers

ZAC Les Hautes Pâtures - Parc d’Activités des Peupliers

923752 Nanterre

France

TETRAZEPAM ZYDUS 50 mg, comprimé enrobé sécable

50 mg

Obložena tableta

Peroralna uporaba

Francija

| Teva Sante |
| --- |
| 110, Esplanade du Général de Gaulle |
| 92931 Paris La Défense Cedex |
| France |

Teva Sante

110, Esplanade du Général de Gaulle

92931 Paris La Défense Cedex

France

TETRAZEPAM TEVA 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Cristers |
| --- |
| 22 quai Gallieni |
| 92150 Suresnes |
| France |

Cristers

22 quai Gallieni

92150 Suresnes

France

TETRAZEPAM CRISTERS 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Ranbaxy Pharmacie Generiques |
| --- |
| 11-15 Quai Dion Bouton |
| 92816 Puteaux |
| France |

Ranbaxy Pharmacie Generiques

11-15 Quai Dion Bouton

92816 Puteaux

France

TETRAZEPAM RPG 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

TETRAZEPAM ZENTIVA 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Mylan SAS |
| --- |
| 117, allée des Parcs |
| 69800 Saint-Priest |
| France |

Mylan SAS

117, allée des Parcs

69800 Saint-Priest

France

TETRAZEPAM MYLAN 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| EG Labo - Laboratoires Eurogenerics |
| --- |
| „Le Quintet“ - bâtiment A |
| 12, rue Danjou |
| 92517 Boulogne Billancourt Cedex |
| France |

EG Labo - Laboratoires Eurogenerics

„Le Quintet“ - bâtiment A

12, rue Danjou

92517 Boulogne Billancourt Cedex

France

TETRAZEPAM EG 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

TETRAZEPAM RATIOPHARM 50 mg, comprimé enrobé sécable

50 mg

Obložena tableta

Peroralna uporaba

Francija

| Arrow Generiques |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

TETRAZEPAM ALMUS 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Arrow Generiques |
| --- |
| 26, avenue Tony Garnier |
| 69007 Lyon |
| France |

Arrow Generiques

26, avenue Tony Garnier

69007 Lyon

France

TETRAZEPAM ARROW 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Francija

| Biogaran |
| --- |
| 15, boulevard Charles de Gaulle |
| 92700 Colombes |
| France |

Biogaran

15, boulevard Charles de Gaulle

92700 Colombes

France

TETRAZEPAM BIOGARAN 50 mg, comprimé pelliculé sécable

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| 1 A Pharma GmbH |
| --- |
| Keltenring 1+3 |
| 82041 Oberhaching |
| Germany |

1 A Pharma GmbH

Keltenring 1+3

82041 Oberhaching

Germany

Tetrazepam - 1 A Pharma

50 mg

Tableta

Peroralna uporaba

Nemčija

| AbZ-Pharma GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

AbZ-Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetrazepam AbZ 50 mg Filmtabletten

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| Aliud Pharma GmbH |
| --- |
| Gottlieb-Daimler-Str. 19 |
| 89150 Laichingen |
| Germany |

Aliud Pharma GmbH

Gottlieb-Daimler-Str. 19

89150 Laichingen

Germany

Tetrazepam AL 50

50 mg

Tableta

Peroralna uporaba

Nemčija

| Aristo Pharma GmbH |
| --- |
| Wallenroder Str. 8-10 |
| 13435 Berlin |
| Germany |

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Spasmorelax 50 mg Tabletten

50 mg

Tableta

Peroralna uporaba

Nemčija

| Aristo Pharma GmbH |
| --- |
| Wallenroder Str. 8-10 |
| 13435 Berlin |
| Germany |

Aristo Pharma GmbH

Wallenroder Str. 8-10

13435 Berlin

Germany

Tetrazepam-Aristo 50 mg Tabletten

50 mg

Tableta

Peroralna uporaba

Nemčija

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetra-saar 50 mg

50 mg

Tableta

Peroralna uporaba

Nemčija

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP 100 mg Tabletten

100 mg

Tableta

Peroralna uporaba

Nemčija

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP 25 mg Tabletten

25 mg

Tableta

Peroralna uporaba

Nemčija

| Chephasaar Chemisch- Pharmazeutische Fabrik GmbH |
| --- |
| Mühlstrasse 50 |
| D-66386 Sankt Ingbert |
| Germany |

Chephasaar Chemisch- Pharmazeutische Fabrik GmbH

Mühlstrasse 50

D-66386 Sankt Ingbert

Germany

Tetrazepam-MIP 50 mg Tabletten

50 mg

Tableta

Peroralna uporaba

Nemčija

| CT Arzneimttel GmbH |
| --- |
| - Geschäftsanschrift - |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

CT Arzneimttel GmbH

- Geschäftsanschrift -

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetrazep-CT 50 mg Filmtabletten

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| Hexal Aktiengesellschaft |
| --- |
| Industriestr. 25 |
| 83607 Holzkirchen |
| Germany |

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Tetrazepam HEXAL

50 mg

Tableta

Peroralna uporaba

Nemčija

| Krewel Meuselbach GmbH |
| --- |
| Krewelstr. 2 |
| 53783 Eitorf |
| Germany |

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Musapam

50 mg

Tableta

Peroralna uporaba

Nemčija

| KSK-Pharma Vertriebs AG |
| --- |
| Finkenstr. 1 |
| 76327 Pfinztal-Berghausen |
| Germany |

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Tetrazepam KSK

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| Mylan dura GmbH |
| --- |
| Wittichstr. 6 |
| 64295 Darmstadt |
| Germany |

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Tetramdura 50 mg

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| neuraxpharm Arzneimittel GmbH |
| --- |
| Elisabeth-Selbert-Str. 23 |
| 40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Tetrazepam-neuraxpharm 100 mg

100 mg

Tableta

Peroralna uporaba

Nemčija

| neuraxpharm Arzneimittel GmbH |
| --- |
| Elisabeth-Selbert-Str. 23 |
| 40764 Langenfeld |
| Germany |

neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Str. 23

40764 Langenfeld

Germany

Tetrazepam-neuraxpharm 50 mg

50 mg

Tableta

Peroralna uporaba

Nemčija

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetrazepam-ratiopharm 50 mg Filmtabletten

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Tetrazepam Sandoz 50 mg Tabletten

50 mg

Tableta

Peroralna uporaba

Nemčija

| Sandoz Pharmaceuticals GmbH |
| --- |
| Raiffeisenstr. 11 |
| 83607 Holzkirchen |
| Germany |

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Tetrazepam Sandoz 50 mg Tabletten

50 mg

Tableta

Peroralna uporaba

Nemčija

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

Sanofi-Aventis Deutschland GmbH

Industriepark Höchst, Gebäude K703

65926 Frankfurt am Main

Germany

Musaril, 50 mg Filmtabletten

50 mg

Filmsko obložena tableta

Peroralna uporaba

Nemčija

| Stadapharm GmbH |
| --- |
| Stadastr. 2-18 |
| 61118 Bad Vilbel |
| Germany |

Stadapharm GmbH

Stadastr. 2-18

61118 Bad Vilbel

Germany

Tetrazepam STADA 50 mg Filmtabletten

50 mg

Filmsko obložena tableta

Peroralna uporaba

Latvija

| Sanofi – Aventis Latvia SIA |
| --- |
| Kr. Valdemara str. 33-8 |
| Riga LV 1010 |
| Latvia |

Sanofi – Aventis Latvia SIA

Kr. Valdemara str. 33-8

Riga LV 1010

Latvia

Myolastan 50 mg film-coated tablets

50 mg

Filmsko obložena tableta

Peroralna uporaba

Litva

| UAB „Sanofi-Aventis Lietuva“ |
| --- |
| A. Juozapavičiaus g. 6/2 |
| LT-09310 Vilnius |
| Lithuania |

UAB „Sanofi-Aventis Lietuva“

A. Juozapavičiaus g. 6/2

LT-09310 Vilnius

Lithuania

Myolastan

50 mg

Filmsko obložena tableta

Peroralna uporaba

Luksemburg

| Will Pharma S.A. |
| --- |
| Monplaisirlaan 33 |
| B-1030 Brussel |
| Belgium |

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Filmsko obložena tableta

Peroralna uporaba

Luksemburg

| Sanofi Aventis Belgium N.V |
| --- |
| Culliganlaan 1C |
| 1831 Diegem |
| Belgium |

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Filmsko obložena tableta

Peroralna uporaba

Luksemburg

| Eurogenerics NV |
| --- |
| Heizel Esplanade b22 |
| 1020 Brussel |
| Belgium |

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Przedsiębiorstwo Farmaceutyczne Jelfa S.A. |
| --- |
| Wincentego st. Pola 21 |
| 58-500, Jelenia Góra, Poland |

Przedsiębiorstwo Farmaceutyczne Jelfa S.A.

Wincentego st. Pola 21

58-500, Jelenia Góra, Poland

Miozepam

50 mg

Filmsko obložena tableta

Peroralna uporaba

Poljska

| Sanofi Aventis France |
| --- |
| 1-13, boulevard Romain Rolland |
| 75014 Paris |
| France |

Sanofi Aventis France

1-13, boulevard Romain Rolland

75014 Paris

France

Myolastan

50 mg

Filmsko obložena tableta

Peroralna uporaba

Poljska

| MIP Pharma Polska Sp. z. o.o. |
| --- |
| ul Orzechowa 5 |
| 80-175 Gdansk |
| Poland |

MIP Pharma Polska Sp. z. o.o.

ul Orzechowa 5

80-175 Gdansk

Poland

Myopam 25

25 mg

Tableta

Peroralna uporaba

Poljska

| MIP Pharma Polska Sp. z. o.o. |
| --- |
| ul Orzechowa 5 |
| 80-175 Gdansk |
| Poland |

MIP Pharma Polska Sp. z. o.o.

ul Orzechowa 5

80-175 Gdansk

Poland

Myopam 50

50 mg

Tableta

Peroralna uporaba

Poljska

| MIP Pharma Polska Sp. z. o.o. |
| --- |
| ul Orzechowa 5 |
| 80-175 Gdansk |
| Poland |

MIP Pharma Polska Sp. z. o.o.

ul Orzechowa 5

80-175 Gdansk

Poland

Myopam 100

100 mg

Tableta

Peroralna uporaba

Poljska

| ratiopharm GmbH |
| --- |
| Graf-Arco-Str. 3 |
| 89079 Ulm |
| Germany |

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetraratio

50 mg

Filmsko obložena tableta

Peroralna uporaba

Romunija

| S.C. A.C. Helcor Pharma S.R.L. |
| --- |
| Str. Victor Babeș nr. 50, Baia Mare |
| Jud. Maramureș |
| România |

S.C. A.C. Helcor Pharma S.R.L.

Str. Victor Babeș nr. 50, Baia Mare

Jud. Maramureș

România

RELAXAM 50 mg, comprimate filmate

50 mg

Filmsko obložena tableta

Peroralna uporaba

Slovaška

| Sanofi-Aventis Slovakia s.r.o. |
| --- |
| Einsteinova 24 |
| 85101 Bratislava |
| Slovak Republic |

Sanofi-Aventis Slovakia s.r.o.

Einsteinova 24

85101 Bratislava

Slovak Republic

MYOLASTAN

50 mg

Filmsko obložena tableta

Peroralna uporaba

Španija

| Sanofi Aventis, S.A. |
| --- |
| Josep Plá, 2 |
| 08019 Barcelona |
| Spain |

Sanofi Aventis, S.A.

Josep Plá, 2

08019 Barcelona

Spain

MYOLASTAN 50 mg comprimidos recubiertos

50 mg

Filmsko obložena tableta

Peroralna uporaba

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