# Official Journal C 184/2013

| | ISSN 1977-091X
  doi:10.3000/1977091X.C_2013.184.eng |
| --- | --- |
| Official Journal
  of the European Union | C 184 |
| | |
| English edition | Information and Notices | Volume 5628 June 2013 |

ISSN 1977-091X

doi:10.3000/1977091X.C_2013.184.eng

Official Journal

of the European Union

C 184

English edition

Information and Notices

Volume 5628 June 2013

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2013/C 184/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  ) | 1 |
| 2013/C 184/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  ) | 10 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2013/C 184/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
  )

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council

)

1

2013/C 184/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
  or Article 38 of Directive 2001/82/EC
  )

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC

or Article 38 of Directive 2001/82/EC

)

10

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 28.6.2013 | EN | Official Journal of the European Union | C 184/1 |
| --- | --- | --- | --- |

28.6.2013

EN

Official Journal of the European Union

C 184/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (1)
  )

2013/C 184/01

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 16.5.2013 | HyQvia | human normal immunoglobulin | Baxter Innovations GmbH |
| Industriestraße 67, A-1221 Wien, Österreich |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

16.5.2013

HyQvia

human normal immunoglobulin

Baxter Innovations GmbH

Industriestraße 67, A-1221 Wien, Österreich

EU/1/13/840

Solution for infusion

J06BA

22.5.2013

16.5.2013

Voriconazole Accord

voriconazole

| 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

Film-coated tablet

J02AC03

22.5.2013

24.5.2013

Stribild

elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil (as fumarate)

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

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

Film-coated tablet

J05AR09

27.5.2013

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Qsiva | VIVUS BV |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.5.2013 | Nevanac | Alcon Laboratories (UK) Ltd. |
| Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
   (2)
  ): Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.5.2013 | Oncept IL-2 | Feline interleukin-2 recombinant canarypox virus (vCP1338) | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorization

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

3.5.2013

Oncept IL-2

Feline interleukin-2 recombinant canarypox virus (vCP1338)

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/150

Lyophilisate and solvent for suspension for injection

QL03AX

7.5.2013

—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.5.2013 | BTVPUR AlSap 1 | Merial |
| 29 avenue Tony Garnier, F-69007 Lyon, France |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

—   Withdrawal of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 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 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorization

Number of the entry in the Community Register

Date of notification

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

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| 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)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.

---

| 28.6.2013 | EN | Official Journal of the European Union | C 184/10 |
| --- | --- | --- | --- |

28.6.2013

EN

Official Journal of the European Union

C 184/10

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2013 to 31 May 2013

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC
   (1)
  or Article 38 of Directive 2001/82/EC
   (2)
  )

2013/C 184/02

—   Issuing, maintenance or modification of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 16.5.2013 | Nuflor Swine Once 450 mg/ml | See Annex I | See Annex I | 21.5.2013 |
| 27.5.2013 | Simvastatin Vale and associated names | See Annex II | See Annex II | 28.5.2013 |
| 23.5.2013 | Florgane | See Annex III | See Annex III | 24.5.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

16.5.2013

Nuflor Swine Once 450 mg/ml

See Annex I

See Annex I

21.5.2013

27.5.2013

Simvastatin Vale and associated names

See Annex II

See Annex II

28.5.2013

23.5.2013

Florgane

See Annex III

See Annex III

24.5.2013

—   Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 14.5.2013 | Furosemide | See Annex IV | See Annex IV | 15.5.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

14.5.2013

Furosemide

See Annex IV

See Annex IV

15.5.2013

—   Suspension of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- |
| 29.5.2013 | Tetrazepam | See Annex V | See Annex V | 29.5.2013 |

Date of the decision

Name(s) of the medicinal product

Holder(s) of the marketing authorization

Member State concerned

Date of notification

29.5.2013

Tetrazepam

See Annex V

See Annex V

29.5.2013

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

---

ANNEX I

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria (1) | Intervet International B.V. |
| Wim de Körverstraat 35 |
| 5831 AN Boxmeer |
| The Netherlands |

Member State

EU/EEA

Applicant

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria (1)

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Belgium

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Bulgaria (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Cyprus

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Czech Republic

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Denmark

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

PigFlor Once

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Estonia

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

France (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Germany (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Greece

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Hungary

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Ireland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Italy

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

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

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Latvia

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Lithuania

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Luxembourg

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Malta

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

The Netherlands

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Poland

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Portugal

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Romania (1)

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Slovakia

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Slovenia

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

Spain

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Flomac porcino dosis única 450 mg/ml solución inyectable

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

United Kingdom

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

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Nuflor Swine Once 450 mg/ml solution for injection

florfenicol

Solution for injection

450 mg/ml

Pigs

Intramuscular

---

(1)  Marketing authorisation granted

---

ANNEX II

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Vale Pharmaceuticals Limited |
| 1b Gurtnafleur Business Park Gurtnafleur, Clonmel |
| Co. Tipperary |
| Ireland |

Member State

EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Austria

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 use

Austria

| 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 use

Denmark

| 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 use

Denmark

| 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 use

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 use

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 use

France

| 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 use

France

| 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 use

Germany

| 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 use

Germany

| 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 use

Greece

| 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 use

Greece

| 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 use

Ireland

| 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 use

Ireland

| 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 use

Italy

| 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 use

Italy

| 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 use

Netherlands

| 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 use

Netherlands

| 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 use

Norway

| 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 use

Norway

| 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 use

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 use

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 use

Spain

| 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 use

Spain

| 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 use

Sweden

| 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 use

Sweden

| 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 use

United Kingdom

| 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 use

United Kingdom

| 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 use

---

ANNEX III

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | Name | INN | Pharmaceutical form | Strength | Animal species | Route of administration |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Austria | Emdoka bvba |
| John Lijsenstraat 16 |
| B-2321 Hoogstraten |
| Belgium |

Member State

EU/EEA

Applicant

Name

INN

Pharmaceutical form

Strength

Animal species

Route of administration

Austria

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Belgium

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Bulgaria

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml инжекционна суспензия за говеда и прасета

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Czech Republic

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml injekční suspenze pro skot a prasata

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Denmark

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

France (1)

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml suspension injectable pour bovins et porcins

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Germany (1)

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml Injektionssuspension für Rinder und Schweine

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Greece

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml Ενέσιμο εναιώρημα για Βοοειδή και χοίρους

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Hungary

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Ireland

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Italy

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml sospensione iniettabile per bovini e suini

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Lithuania

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml injekcinė suspensija galvijams ir kiaulėms

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Luxembourg

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml suspension injectable pour bovins et porcins

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

The Netherlands

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Poland

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Portugal

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml suspensão injectável para bovinos e suínos

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Romania

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml suspensie injectabilă pentru bovine și porcine

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Slovakia

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

Spain (1)

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

Florgane 300 mg/ml suspensión inyectable para bovino y porcino

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

United Kingdom

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

Emdoka bvba

John Lijsenstraat 16

B-2321 Hoogstraten

Belgium

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

florfenicol

Suspension for injection

300 mg/ml

Cattle and pigs

Intramuscular

---

(1)  Marketing authorisation granted

---

ANNEX IV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT IN THE MEMBER STATES

| Member State
  EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Czech Republic | Vitabalans Oy Varastokatu 8 |
| 13500 Hämeenlinna |
| Finland |

Member State

EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Czech Republic

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tablety

40 mg

Tablet

Oral use

Denmark

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

Estonia

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

Finland

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

Hungary

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans

40 mg

Tablet

Oral use

Latvia

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans 40 mg tabletes

40 mg

Tablet

Oral use

Lithuania

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

Norway

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

Poland

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

Slovak Republic

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablety

40 mg

Tablet

Oral use

Slovenia

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemid Vitabalans 40 mg tablete

40 mg

Tablet

Oral use

Sweden

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

Vitabalans Oy Varastokatu 8

13500 Hämeenlinna

Finland

Furosemide Vitabalans

40 mg

Tablet

Oral use

---

ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES

| Member State (in EEA) | Marketing authorisaton holder | Product name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | Sanofi-Aventis GmbH |
| Leonard-Bernstein-Str. 10 |
| Vienna DC |
| A-1220 Vienna |
| Austria |

Member State (in EEA)

Marketing authorisaton holder

Product name

Strength

Pharmaceutical form

Route of administration

Austria

Sanofi-Aventis GmbH

Leonard-Bernstein-Str. 10

Vienna DC

A-1220 Vienna

Austria

Myolastan 50 mg - Filmtabletten

50 mg

Film-coated tablet

Oral use

Austria

| 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 use

Belgium

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

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Film-coated tablet

Oral use

Belgium

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

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Film-coated tablet

Oral use

Belgium

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

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Film-coated tablet

Oral use

Bulgaria

| 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 use

Czech Republic

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

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

Cristers

22 quai Gallieni

92150 Suresnes

France

TETRAZEPAM CRISTERS 50 mg, comprimé pelliculé sécable

50 mg

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

France

| 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

Film-coated tablet

Oral use

Germany

| 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 use

Germany

| 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

Film-coated tablet

Oral use

Germany

| 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 use

Germany

| 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 use

Germany

| 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 use

Germany

| 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 use

Germany

| 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 use

Germany

| 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 use

Germany

| 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 use

Germany

| 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

Film-coated tablet

Oral use

Germany

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

Hexal Aktiengesellschaft

Industriestr. 25

83607 Holzkirchen

Germany

Tetrazepam HEXAL

50 mg

Tablet

Oral use

Germany

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

Krewel Meuselbach GmbH

Krewelstr. 2

53783 Eitorf

Germany

Musapam

50 mg

Tablet

Oral use

Germany

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

KSK-Pharma Vertriebs AG

Finkenstr. 1

76327 Pfinztal-Berghausen

Germany

Tetrazepam KSK

50 mg

Film-coated tablet

Oral use

Germany

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

Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

Tetramdura 50 mg

50 mg

Film-coated tablet

Oral use

Germany

| 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 use

Germany

| 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 use

Germany

| 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

Film-coated tablet

Oral use

Germany

| 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 use

Germany

| 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 use

Germany

| 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

Film-coated tablet

Oral use

Germany

| 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

Film-coated tablet

Oral use

Latvia

| 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

Film-coated tablet

Oral use

Lithuania

| 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

Film-coated tablet

Oral use

Luxembourg

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

Will Pharma S.A.

Monplaisirlaan 33

B-1030 Brussel

Belgium

Epsipam

50 mg

Film-coated tablet

Oral use

Luxembourg

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

Sanofi Aventis Belgium N.V

Culliganlaan 1C

1831 Diegem

Belgium

Myolastan

50 mg

Film-coated tablet

Oral use

Luxembourg

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

Eurogenerics NV

Heizel Esplanade b22

1020 Brussel

Belgium

Tetrazepam EG

50 mg

Film-coated tablet

Oral use

Poland

| 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

Film-coated tablet

Oral use

Poland

| 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

Film-coated tablet

Oral use

Poland

| 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 use

Poland

| 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 use

Poland

| 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 use

Poland

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

ratiopharm GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Tetraratio

50 mg

Film-coated tablet

Oral use

Romania

| 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

Film-coated tablet

Oral use

Slovak Republic

| 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

Film-coated tablet

Oral use

Spain

| 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

Film-coated tablet

Oral use

---