# Den Europæiske Unions C 184/2013

| | ISSN 1977-0871
  doi:10.3000/19770871.C_2013.184.dan |
| --- | --- |
| Den Europæiske Unions
  Tidende | C 184 |
| | |
| Dansk udgave | Meddelelser og oplysninger | 56. årgang28. juni 2013 |

ISSN 1977-0871

doi:10.3000/19770871.C_2013.184.dan

Den Europæiske Unions

Tidende

C 184

Dansk udgave

Meddelelser og oplysninger

56. årgang28. juni 2013

---

| Informationsnummer | Indhold | Side |
| --- | --- | --- |
| | IV   Oplysninger |
| | OPLYSNINGER FRA DEN EUROPÆISKE UNIONS INSTITUTIONER, ORGANER, KONTORER OG AGENTURER |
| | Europa-Kommissionen |
| 2013/C 184/01 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. maj 2013 til 31. maj 2013(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
  ) | 1 |
| 2013/C 184/02 | Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. maj 2013 til 31. maj 2013(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
  eller artikel 38 i direktiv 2001/82/EF
  ) | 10 |

Informationsnummer

Indhold

Side

IV   Oplysninger

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

Europa-Kommissionen

2013/C 184/01

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. maj 2013 til 31. maj 2013(Offentliggjort i henhold til artikel 13 eller artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
  )

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

)

1

2013/C 184/02

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. maj 2013 til 31. maj 2013(Afgørelser truffet i henhold til artikel 34 i direktiv 2001/83/EF
  eller artikel 38 i direktiv 2001/82/EF
  )

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

eller artikel 38 i direktiv 2001/82/EF

)

10

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

DA

---

IV Oplysninger

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

Europa-Kommissionen

| 28.6.2013 | DA | Den Europæiske Unions Tidende | C 184/1 |
| --- | --- | --- | --- |

28.6.2013

DA

Den Europæiske Unions Tidende

C 184/1

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. maj 2013 til 31. maj 2013

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

2013/C 184/01

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

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.5.2013 | HyQvia | Humant normalt immunglobulin | Baxter Innovations GmbH |
| Industriestraße 67, A-1221 Wien, Österreich |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

16.5.2013

HyQvia

Humant normalt immunglobulin

Baxter Innovations GmbH

Industriestraße 67, A-1221 Wien, Österreich

EU/1/13/840

Infussionsvæske, opløsning

J06BA

22.5.2013

16.5.2013

Voriconazole Accord

Voriconazol

| 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

Filmovertrukket tablet

J02AC03

22.5.2013

24.5.2013

Stribild

elvitegravir/cobicistat/emtricitabin/tenofovirdisoproxil (som fumarat)

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

Filmovertrukket tablet

J05AR09

27.5.2013

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

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Qsiva | VIVUS BV |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

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

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 3.5.2013 | Nevanac | Alcon Laboratories (UK) Ltd. |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

Xarelto

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

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

24.5.2013

22.5.2013

Оlanzapin 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

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

—   Udstedelse af markedsføringstilladelse (artikel 38 i Europa-Parlamentets og Rådets forordning (EF) nr. 726/2004
   (2)
  ): Godkendt

| Dato for afgørelser | Lægemidlets navn | INN-navn (International Non-Proprietary Name) | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Lægemiddelform | ATC-kode (Anatomical Therapeutic Chemical Code) | Dato for notifikation |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.5.2013 | Oncept IL-2 | Felint interleukin-2 rekombinant canarypox virus (vCP1338) | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Dato for afgørelser

Lægemidlets navn

INN-navn (International Non-Proprietary Name)

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Lægemiddelform

ATC-kode (Anatomical Therapeutic Chemical Code)

Dato for notifikation

3.5.2013

Oncept IL-2

Felint interleukin-2 rekombinant canarypox virus (vCP1338)

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/150

Lyofilisat og solvens til injektionsvæske, suspension

QL03AX

7.5.2013

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

| Dato for afgørelser | Lægemidlets navn | Indehaver af markedsføringstilladelsen | Nummer i EF-registret | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 6.5.2013 | BTVPUR AlSap 1 | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

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

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

Dato for afgørelser

Lægemidlets navn

Indehaver af markedsføringstilladelsen

Nummer i EF-registret

Dato for notifikation

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

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

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

The European Medicines Agency

7, Westferry Circus,

Canary Wharf

UK-LONDON E14 4H

---

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

(2)  EUT L 136 af 30.4.2004, s. 1.

---

| 28.6.2013 | DA | Den Europæiske Unions Tidende | C 184/10 |
| --- | --- | --- | --- |

28.6.2013

DA

Den Europæiske Unions Tidende

C 184/10

---

Oversigt over EU-afgørelser om tilladelse til markedsføring af lægemidler fra 1. maj 2013 til 31. maj 2013

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

2013/C 184/02

—   Udstedelse, videreførsel eller ændring af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 16.5.2013 | Nuflor Swine Once 450 mg/ml | Se bilaget I | Se bilaget I | 21.5.2013 |
| 27.5.2013 | Simvastatin Vale and associated names | Se bilaget II | Se bilaget II | 28.5.2013 |
| 23.5.2013 | Florgane | Se bilaget III | Se bilaget III | 24.5.2013 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

16.5.2013

Nuflor Swine Once 450 mg/ml

Se bilaget I

Se bilaget I

21.5.2013

27.5.2013

Simvastatin Vale and associated names

Se bilaget II

Se bilaget II

28.5.2013

23.5.2013

Florgane

Se bilaget III

Se bilaget III

24.5.2013

—   Afvisning af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Furosemide | Se bilaget IV | Se bilaget IV | 15.5.2013 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

14.5.2013

Furosemide

Se bilaget IV

Se bilaget IV

15.5.2013

—   Suspension af en national markedsføringstilladelse

| Dato for afgørelser | Lægemidlets navn/navne | Indehaver/indehavere af markedsføringstilladelsen | Medlemsstat | Dato for notifikation |
| --- | --- | --- | --- | --- |
| 29.5.2013 | Tetrazepam | Se bilaget V | Se bilaget V | 29.5.2013 |

Dato for afgørelser

Lægemidlets navn/navne

Indehaver/indehavere af markedsføringstilladelsen

Medlemsstat

Dato for notifikation

29.5.2013

Tetrazepam

Se bilaget V

Se bilaget V

29.5.2013

---

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

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

---

ANNEX I

LISTE OVER NAVNE, LÆGEMIDDELFORM, STYRKE PÅ DET VETERINÆRMEDICINSKE PRODUKT, DYREARTER, ADMINISTRATIONSMÅDE, ANSØGER I MEDLEMSLANDENE

| Medlemsland
  EU/EEA | Ansøger | Navn | INN | Lægemiddelform | Styrke | Dyrearter | Administrationsvej |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Østrig (1) | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| Holland |

Medlemsland

EU/EEA

Ansøger

Navn

INN

Lægemiddelform

Styrke

Dyrearter

Administrationsvej

Østrig (1)

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Belgien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Bulgarien (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Cypern

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Tjekkiet

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Danmark

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

PigFlor Once 450 mg/ml injektionsvæske, opløsning

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Estland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Frankrig (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Tyskland (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Grækenland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Ungarn

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Irland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Italien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

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

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Letland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Litauen

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Luxembourg

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Malta

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Holland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Polen

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Portugal

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Rumænien (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Slovakiet

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Slovenien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

Spanien

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Flomac porcino dosis única 450 mg/ml solución inyectable

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

England

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

Holland

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Injektionsvæske, opløsning

450 mg/ml

Svin

Intramuskulær

---

(1)  Marketing authorisation granted

---

BILAG II

LISTE OVER NAVNE, LÆGEMIDDELFORM, LÆGEMIDLETS STYRKE, ADMINISTRATIONSVEJ, ANSØGER I MEDLEMSSTATERNE

| Medlemsland
  EU/EØS | Ansøger | Særnavn | Styrke | Lægemiddelform | Administrationsvej |
| --- | --- | --- | --- | --- | --- |
| Østrig | Vale Pharmaceuticals Limited |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Medlemsland

EU/EØS

Ansøger

Særnavn

Styrke

Lægemiddelform

Administrationsvej

Østrig

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

oral suspension

oral anvendelse

Østrig

| 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

oral suspension

oral anvendelse

Danmark

| 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

oral suspension

oral anvendelse

Danmark

| 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

oral suspension

oral anvendelse

Finland

| 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

oral suspension

oral anvendelse

Finland

| 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

oral suspension

oral anvendelse

Frankrig

| 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

oral suspension

oral anvendelse

Frankrig

| 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

oral suspension

oral anvendelse

Tyskland

| 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

oral suspension

oral anvendelse

Tyskland

| 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

oral suspension

oral anvendelse

Grækenland

| 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

oral suspension

oral anvendelse

Grækenland

| 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

oral suspension

oral anvendelse

Irland

| 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

oral suspension

oral anvendelse

Irland

| 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

oral suspension

oral anvendelse

Italien

| 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

oral suspension

oral anvendelse

Italien

| 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

oral suspension

oral anvendelse

Holland

| 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

oral suspension

oral anvendelse

Holland

| 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

oral suspension

oral anvendelse

Norge

| 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

oral suspension

oral anvendelse

Norge

| 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

oral suspension

oral anvendelse

Portugal

| 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

oral suspension

oral anvendelse

Portugal

| 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

oral suspension

oral anvendelse

Spanien

| 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

oral suspension

oral anvendelse

Spanien

| 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

oral suspension

oral anvendelse

Sverige

| 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

oral suspension

oral anvendelse

Sverige

| 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

oral suspension

oral anvendelse

Det Forenede Kongerige

| 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

oral suspension

oral anvendelse

Det Forenede Kongerige

| 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

oral suspension

oral anvendelse

---

BILAG III

LISTE OVER VETERINÆRLÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, MÅLDYREARTER, ADMINISTRATIONSVEJ OG ANSØGER OM MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE

| Medlemsstat
  EU/EØS | Ansøger | Navn | INN | Lægemiddelform | Styrke | Dyrearter | Administrationsvej |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Østrig | Emdoka bvba |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgien |

Medlemsstat

EU/EØS

Ansøger

Navn

INN

Lægemiddelform

Styrke

Dyrearter

Administrationsvej

Østrig

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Belgian

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Bulgarien

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml инжекционна суспензия за говеда и прасета

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Tjekkiet

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml injekční suspenze pro skot a prasata

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Danmark

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

France (1)

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml suspension injectable pour bovins et porcins

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Tyskland (1)

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Grækenland

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml Ενέσιμο εναιώρημα για Βοοειδή και χοίρους

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Ungarn

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Irland

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Italien

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml sospensione iniettabile per bovini e suini

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Liauen

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml injekcinė suspensija galvijams ir kiaulėms

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Luxembourg

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 Mg/Ml suspension injectable pour bovins et porcins

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Nederlandene

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Polen

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Portugal

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml suspensão injectável para bovinos e suínos

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Rumænien

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml suspensie injectabilă pentru bovine și porcine

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Slovakiet

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Spanien (1)

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

Florgane 300 mg/ml suspensión inyectable para bovino y porcino

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

Det Forenede Kongerige

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgien

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

florfenicol

Injektionsvæske, suspension

300 mg/ml

Kvæg og svin

Intramuskulær anvendelse

---

(1)  Markedsføringstilladelse udstedt.

---

BILAG IV

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKE, INDGIVELSESVEJ, ANSØGERE I MEDLEMSSTATERNE

| Medlemsstat
  EU/EEA | Ansøger | (Handels) navn | Styrke | Lægemiddelform | Indgivelsesvej |
| --- | --- | --- | --- | --- | --- |
| Tjekkiet | Vitabalans Oy Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Medlemsstat

EU/EEA

Ansøger

(Handels) navn

Styrke

Lægemiddelform

Indgivelsesvej

Tjekkiet

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tablety

40 mg

tablet

oral anvendelse

Danmark

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

Estland

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

Finland

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

Ungarn

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans

40 mg

tablet

oral anvendelse

Letland

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tabletes

40 mg

tablet

oral anvendelse

Litauen

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

Norge

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

Polen

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

Slovak Republik

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablety

40 mg

tablet

oral anvendelse

Slovenien

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablete

40 mg

tablet

oral anvendelse

Sver

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

tablet

oral anvendelse

---

BILAG V

FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE

| Medlemsstat (i EØS) | Indehaver af markedsførings- tilladelsen | Særnavn Navn | Styrke | Lægemiddelform | Administration |
| --- | --- | --- | --- | --- | --- |
| Østrig | Sanofi-Aventis GmbH |
| Leonard-Bernstein-Str. 10 |
| Vienna DC |
| A-1220 Vienna |
| Austria |

Medlemsstat (i EØS)

Indehaver af markedsførings- tilladelsen

Særnavn Navn

Styrke

Lægemiddelform

Administration

Østrig

Sanofi-Aventis GmbH

Leonard-Bernstein-Str. 10

Vienna DC

A-1220 Vienna

Austria

Myolastan 50 mg - Filmtabletten

50 mg

Filmovertrukket tablet

Oral anvendelse

Østrig

| 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

Tablet

Oral anvendelse

Belgien

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

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Filmovertrukket tablet

Oral anvendelse

Belgien

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

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Filmovertrukket tablet

Oral anvendelse

Belgien

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

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Filmovertrukket tablet

Oral anvendelse

Bulgarien

| 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

Tablet

Oral anvendelse

Den Tjekkiske republik

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Overtrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

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

Cristers

22 quai Gallieni

92150 Suresnes

France

TETRAZEPAM CRISTERS 50 mg, comprimé pelliculé sécable

50 mg

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Overtrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Frankrig

| 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

Filmovertrukket tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Filmovertrukket tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Filmovertrukket tablet

Oral anvendelse

Tyskland

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

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Tetrazepam HEXAL

50 mg

Tablet

Oral anvendelse

Tyskland

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

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Musapam

50 mg

Tablet

Oral anvendelse

Tyskland

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

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Tetrazepam KSK

50 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Tetramdura 50 mg

50 mg

Filmovertrukket tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Tablet

Oral anvendelse

Tyskland

| 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

Filmovertrukket tablet

Oral anvendelse

Tyskland

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Tetrazepam Sandoz 50 mg Tabletten

50 mg

Tablet

Oral anvendelse

Tyskland

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

Sandoz Pharmaceuticals GmbH

Raiffeisenstr. 11

83607 Holzkirchen

Germany

Tetrazepam Sandoz 50 mg Tabletten

50 mg

Tablet

Oral anvendelse

Tyskland

| 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

Filmovertrukket tablet

Oral anvendelse

Tyskland

| 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

Filmovertrukket tablet

Oral anvendelse

Letland

| 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

Filmovertrukket tablet

Oral anvendelse

Litauen

| 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

Filmovertrukket tablet

Oral anvendelse

Luxembourg

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

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Filmovertrukket tablet

Oral anvendelse

Luxembourg

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

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Filmovertrukket tablet

Oral anvendelse

Luxembourg

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

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Filmovertrukket tablet

Oral anvendelse

Polen

| 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

Filmovertrukket tablet

Oral anvendelse

Polen

| 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

Filmovertrukket tablet

Oral anvendelse

Polen

| 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

Tablet

Oral anvendelse

Polen

| 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

Tablet

Oral anvendelse

Polen

| 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

Tablet

Oral anvendelse

Polen

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

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetraratio

50 mg

Filmovertrukket tablet

Oral anvendelse

Rumænien

| 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

Filmovertrukket tablet

Oral anvendelse

Slovakiet

| 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

Filmovertrukket tablet

Oral anvendelse

Spanien

| 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

Filmovertrukket tablet

Oral anvendelse

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