# C_2014290EN.01000101.xml

| 29.8.2014 | EN | Official Journal of the European Union | C 290/1 |
| --- | --- | --- | --- |

29.8.2014

EN

Official Journal of the European Union

C 290/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014

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

1

2014/C 290/01

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

Issuing of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.7.2014 | Envarsus | tacrolimus | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/935 | Prolonged-release tablet | L04AD02 | 22.7.2014 |
| 18.7.2014 | Plegridy | peginterferon beta-1a | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/14/934 | Solution for injection | L03AB13 | 23.7.2014 |
| 18.7.2014 | Simbrinza | Brinzolamide/Brimonidine tartrate | Alcon Laboratories (UK) Ltd.
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/14/933 | Ear drops, suspension | Pending | 23.7.2014 |
| 22.7.2014 | Nuwiq | simoctocog alfa | Octapharma AB
  Elersvägen 40 Stockholm 11275 Sweden | EU/1/14/936 | Powder and solvent for solution for injection | B02BD02 | 24.7.2014 |
| 23.7.2014 | Gazyvaro | obinutuzumab | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | Concentrate for solution for infusion | L01 | 24.7.2014 |
| 31.7.2014 | Translarna | ataluren | PTC Therapeutics, Limited
  Lakeside House, Office G33a, 1 Furzeground Way, Stockley Park E. Uxbridge, UB11 1BD, United Kingdom | EU/1/13/902 | Granules for oral suspension | Pending | 5.8.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

18.7.2014

Envarsus

tacrolimus

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/935

Prolonged-release tablet

L04AD02

22.7.2014

18.7.2014

Plegridy

peginterferon beta-1a

Biogen Idec Limited

Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom

EU/1/14/934

Solution for injection

L03AB13

23.7.2014

18.7.2014

Simbrinza

Brinzolamide/Brimonidine tartrate

Alcon Laboratories (UK) Ltd.

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

EU/1/14/933

Ear drops, suspension

Pending

23.7.2014

22.7.2014

Nuwiq

simoctocog alfa

Octapharma AB

Elersvägen 40 Stockholm 11275 Sweden

EU/1/14/936

Powder and solvent for solution for injection

B02BD02

24.7.2014

23.7.2014

Gazyvaro

obinutuzumab

Roche Registration Limited

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

EU/1/14/937

Concentrate for solution for infusion

L01

24.7.2014

31.7.2014

Translarna

ataluren

PTC Therapeutics, Limited

Lakeside House, Office G33a, 1 Furzeground Way, Stockley Park E. Uxbridge, UB11 1BD, United Kingdom

EU/1/13/902

Granules for oral suspension

Pending

5.8.2014

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

Issuing of a marketing authorisation

Rejected

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.7.2014 | Masican | AB Science S.A.
  3 avenue George V, F-75008 Paris, France | | 8.7.2014 |
| 23.7.2014 | Masiviera | AB Science S.A.
  3 avenue George V, F-75008 Paris, France | | 24.7.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.7.2014

Masican

AB Science S.A.

3 avenue George V, F-75008 Paris, France

8.7.2014

23.7.2014

Masiviera

AB Science S.A.

3 avenue George V, F-75008 Paris, France

24.7.2014

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.7.2014 | Copalia HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/575 | 11.7.2014 |
| 4.7.2014 | Dafiro HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/574 | 11.7.2014 |
| 4.7.2014 | Efavirenz Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/742 | 9.7.2014 |
| 4.7.2014 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa | EU/1/07/404 | 8.7.2014 |
| 4.7.2014 | Fuzeon | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/252 | 8.7.2014 |
| 4.7.2014 | Optison | GE Healthcare AS
  Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge | EU/1/98/065 | 8.7.2014 |
| 11.7.2014 | Riluzole Zentiva | Aventis Pharma S.A.
  20 avenue Raymond Aron, F-92165 Antony CEDEX, France | EU/1/12/768 | 15.7.2014 |
| 11.7.2014 | Rivastigmine HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/09/589 | 15.7.2014 |
| 11.7.2014 | Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH
  Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | EU/1/09/599 | 15.7.2014 |
| 14.7.2014 | Docetaxel Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/611 | 17.7.2014 |
| 14.7.2014 | Viagra | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/98/077 | 16.7.2014 |
| 18.7.2014 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 22.7.2014 |
| 18.7.2014 | CellCept | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/005 | 22.7.2014 |
| 18.7.2014 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 23.7.2014 |
| 18.7.2014 | Glivec | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/198 | 22.7.2014 |
| 18.7.2014 | Irbesartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/576 | 23.7.2014 |
| 18.7.2014 | Nimenrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/12/767 | 22.7.2014 |
| 18.7.2014 | Omnitrope | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/06/332 | 22.7.2014 |
| 18.7.2014 | Onglyza | Bristol-Myers Squibb/AstraZeneca EEIG
  Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/09/545 | 22.7.2014 |
| 18.7.2014 | SANCUSO | ProStrakan Limited
  Galabank Business Park, Galashiels TD1 1QH, United Kingdom | EU/1/12/766 | 23.7.2014 |
| 18.7.2014 | Savene | Clinigen Healthcare Limited
  Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom | EU/1/06/350 | 22.7.2014 |
| 18.7.2014 | Tasmar | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/97/044 | 22.7.2014 |
| 18.7.2014 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Fehlandtstraße 3, D-20354 Hamburg, Deutschland | EU/1/09/605 | 22.7.2014 |
| 18.7.2014 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 22.7.2014 |
| 18.7.2014 | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/255 | 22.7.2014 |
| 18.7.2014 | Votubia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/11/710 | 23.7.2014 |
| 18.7.2014 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 23.7.2014 |
| 18.7.2014 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 23.7.2014 |
| 22.7.2014 | Rapiscan | Rapidscan Pharma Solutions EU Ltd.
  Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom | EU/1/10/643 | 24.7.2014 |
| 23.7.2014 | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/01/188 | 24.7.2014 |
| 28.7.2014 | Arzerra | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/10/625 | 30.7.2014 |
| 28.7.2014 | Byetta | AstraZeneca AB
  S-151 85 Södertälje, Sverige | EU/1/06/362 | 30.7.2014 |
| 28.7.2014 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 30.7.2014 |
| 28.7.2014 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 29.7.2014 |
| 28.7.2014 | Kalydeco | Vertex Pharmaceuticals (U.K.) Limited
  Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom | EU/1/12/782 | 30.7.2014 |
| 28.7.2014 | Menveo | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/614 | 29.7.2014 |
| 28.7.2014 | Olanzapine Apotex | Apotex Europe B.V.
  Darwinweg 20, NL- 2333 CR Leiden, Nederland | EU/1/10/635 | 29.7.2014 |
| 28.7.2014 | Pandemrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/08/452 | 30.7.2014 |
| 28.7.2014 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 30.7.2014 |
| 28.7.2014 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 29.7.2014 |
| 31.7.2014 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 4.8.2014 |
| 31.7.2014 | BYDUREON | Bristol-Myers Squibb/AstraZeneca EEIG
  Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/696 | 4.8.2014 |
| 31.7.2014 | Colobreathe | Forest Laboratories UK Ltd
  Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom | EU/1/11/747 | 1.8.2014 |
| 31.7.2014 | Xarelto | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/08/472 | 4.8.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

4.7.2014

Copalia HCT

Novartis Europharm Limited

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

EU/1/09/575

11.7.2014

4.7.2014

Dafiro HCT

Novartis Europharm Limited

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

EU/1/09/574

11.7.2014

4.7.2014

Efavirenz Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/742

9.7.2014

4.7.2014

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa

EU/1/07/404

8.7.2014

4.7.2014

Fuzeon

Roche Registration Limited

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

EU/1/03/252

8.7.2014

4.7.2014

Optison

GE Healthcare AS

Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge

EU/1/98/065

8.7.2014

11.7.2014

Riluzole Zentiva

Aventis Pharma S.A.

20 avenue Raymond Aron, F-92165 Antony CEDEX, France

EU/1/12/768

15.7.2014

11.7.2014

Rivastigmine HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/09/589

15.7.2014

11.7.2014

Rivastigmine Sandoz

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/09/599

15.7.2014

14.7.2014

Docetaxel Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/611

17.7.2014

14.7.2014

Viagra

Pfizer Limited

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

EU/1/98/077

16.7.2014

18.7.2014

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

22.7.2014

18.7.2014

CellCept

Roche Registration Limited

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

EU/1/96/005

22.7.2014

18.7.2014

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

23.7.2014

18.7.2014

Glivec

Novartis Europharm Limited

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

EU/1/01/198

22.7.2014

18.7.2014

Irbesartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/576

23.7.2014

18.7.2014

Nimenrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/12/767

22.7.2014

18.7.2014

Omnitrope

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/06/332

22.7.2014

18.7.2014

Onglyza

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/09/545

22.7.2014

18.7.2014

SANCUSO

ProStrakan Limited

Galabank Business Park, Galashiels TD1 1QH, United Kingdom

EU/1/12/766

23.7.2014

18.7.2014

Savene

Clinigen Healthcare Limited

Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom

EU/1/06/350

22.7.2014

18.7.2014

Tasmar

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/97/044

22.7.2014

18.7.2014

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Fehlandtstraße 3, D-20354 Hamburg, Deutschland

EU/1/09/605

22.7.2014

18.7.2014

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

22.7.2014

18.7.2014

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

22.7.2014

18.7.2014

Votubia

Novartis Europharm Limited

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

EU/1/11/710

23.7.2014

18.7.2014

Xagrid

Shire Pharmaceutical Contracts Ltd

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

EU/1/04/295

23.7.2014

18.7.2014

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

23.7.2014

22.7.2014

Rapiscan

Rapidscan Pharma Solutions EU Ltd.

Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom

EU/1/10/643

24.7.2014

23.7.2014

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188

24.7.2014

28.7.2014

Arzerra

Glaxo Group Ltd

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

EU/1/10/625

30.7.2014

28.7.2014

Byetta

AstraZeneca AB

S-151 85 Södertälje, Sverige

EU/1/06/362

30.7.2014

28.7.2014

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

30.7.2014

28.7.2014

Enbrel

Pfizer Limited

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

EU/1/99/126

29.7.2014

28.7.2014

Kalydeco

Vertex Pharmaceuticals (U.K.) Limited

Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom

EU/1/12/782

30.7.2014

28.7.2014

Menveo

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/614

29.7.2014

28.7.2014

Olanzapine Apotex

Apotex Europe B.V.

Darwinweg 20, NL- 2333 CR Leiden, Nederland

EU/1/10/635

29.7.2014

28.7.2014

Pandemrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/08/452

30.7.2014

28.7.2014

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

30.7.2014

28.7.2014

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

29.7.2014

31.7.2014

Avastin

Roche Registration Limited

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

EU/1/04/300

4.8.2014

31.7.2014

BYDUREON

Bristol-Myers Squibb/AstraZeneca EEIG

Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/696

4.8.2014

31.7.2014

Colobreathe

Forest Laboratories UK Ltd

Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom

EU/1/11/747

1.8.2014

31.7.2014

Xarelto

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

4.8.2014

—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorisation

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.7.2014 | Olanzapine Cipla | Cipla (EU) Limited
  Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom | EU/1/07/426 | 10.7.2014 |
| 31.7.2014 | Doribax | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/467 | 4.8.2014 |
| 31.7.2014 | IOA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/689 | 4.8.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

8.7.2014

Olanzapine Cipla

Cipla (EU) Limited

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

EU/1/07/426

10.7.2014

31.7.2014

Doribax

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/467

4.8.2014

31.7.2014

IOA

Merck Sharp & Dohme Limited

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

EU/1/11/689

4.8.2014

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

Issuing of a marketing authorisation

2

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.7.2014 | ERYSENG | Inactivated Erysipelothrix rhusiopathiae, strain R32E11 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/14/166 | Suspension for injection | QI09AB03 | 8.7.2014 |
| 4.7.2014 | Versican Plus DHPPi | Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza type 2 virus | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/169 | Lyophilisate and solvent for suspension for injection | QI07AD04 | 8.7.2014 |
| 4.7.2014 | Versican Plus Pi | Canine parainfluenza type 2 virus | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/168 | Lyophilisate and solvent for suspension for injection | QI07AD08 | 8.7.2014 |
| 8.7.2014 | ERYSENG PARVO | Inactivated porcine parvovirus, strain NADL-2/Inactivated Erysipelothrix rhusiopathiae, strain R32E11 | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/14/167 | Suspension for injection | QI09AL01 | 10.7.2014 |
| 31.7.2014 | Osurnia | terbinafine/florfenicol/betamethasone acetate | Novartis Santé Animale S.A.S.
  10 Rue Blériot, 92 500 Rueil-Malmaison, France | EU/2/14/170 | Ear gel | QS02CA90 | 1.8.2014 |
| 31.7.2014 | Versican Plus L4 | Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
  Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
  Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
  Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/171 | Suspension for injection | QI07AB01 | 5.8.2014 |
| 31.7.2014 | Versican Plus Pi/L4 | Canine parainfluenza type 2 virus
  Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
  Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
  Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
  Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/14/172 | Lyophilisate for suspension for spray vaccination | QI07AI08 | 4.8.2014 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

4.7.2014

ERYSENG

Inactivated Erysipelothrix rhusiopathiae, strain R32E11

Erysipelothrix rhusiopathiae

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/14/166

Suspension for injection

QI09AB03

8.7.2014

4.7.2014

Versican Plus DHPPi

Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza type 2 virus

Zoetis Belgium S.A.

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

EU/2/14/169

Lyophilisate and solvent for suspension for injection

QI07AD04

8.7.2014

4.7.2014

Versican Plus Pi

Canine parainfluenza type 2 virus

Zoetis Belgium S.A.

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

EU/2/14/168

Lyophilisate and solvent for suspension for injection

QI07AD08

8.7.2014

8.7.2014

ERYSENG PARVO

Inactivated porcine parvovirus, strain NADL-2/Inactivated Erysipelothrix rhusiopathiae, strain R32E11

Erysipelothrix rhusiopathiae

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170- Amer (Girona), España

EU/2/14/167

Suspension for injection

QI09AL01

10.7.2014

31.7.2014

Osurnia

terbinafine/florfenicol/betamethasone acetate

Novartis Santé Animale S.A.S.

10 Rue Blériot, 92 500 Rueil-Malmaison, France

EU/2/14/170

Ear gel

QS02CA90

1.8.2014

31.7.2014

Versican Plus L4

Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089

Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090

Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091

Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088

Zoetis Belgium S.A.

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

EU/2/14/171

Suspension for injection

QI07AB01

5.8.2014

31.7.2014

Versican Plus Pi/L4

Canine parainfluenza type 2 virus

Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089

Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090

Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091

Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088

Zoetis Belgium S.A.

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

EU/2/14/172

Lyophilisate for suspension for spray vaccination

QI07AI08

4.8.2014

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 8.7.2014 | Draxxin | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/03/041 | 10.7.2014 |
| 8.7.2014 | SevoFlo | Abbott Laboratories Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom | EU/2/02/035 | 10.7.2014 |
| 11.7.2014 | ProteqFlu | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/03/037 | 15.7.2014 |
| 11.7.2014 | ProteqFlu-Te | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/03/038 | 15.7.2014 |
| 28.7.2014 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/12/140 | 29.7.2014 |
| 31.7.2014 | Palladia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | EU/2/09/100 | 4.8.2014 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

8.7.2014

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

10.7.2014

8.7.2014

SevoFlo

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom

EU/2/02/035

10.7.2014

11.7.2014

ProteqFlu

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/03/037

15.7.2014

11.7.2014

ProteqFlu-Te

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/03/038

15.7.2014

28.7.2014

Poulvac E. coli

Zoetis Belgium S.A.

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

EU/2/12/140

29.7.2014

31.7.2014

Palladia

Zoetis Belgium S.A.

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

EU/2/09/100

4.8.2014

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 |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

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

1

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

2

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