# C_2013350EN.01002601.xml

| 29.11.2013 | EN | Official Journal of the European Union | C 350/26 |
| ---------- | -- | -------------------------------------- | -------- |

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

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

2013/C 350/02

—   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 |
| --------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------- | ----------------------------------------------- | -------------------- |
| 18.10.2013 | Defitelio | defibrotide | Gentium S.p.A. Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia | Gentium S.p.A. | Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), | Italia | EU/1/13/878 |
| Gentium S.p.A. | | | | | | | |
| Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), | | | | | | | |
| Italia | | | | | | | |
| 18.10.2013 | Grastofil | filgrastim | Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwinweg 20, NL- 2333 CR Leiden, | Nederland | EU/1/13/877 |
| Apotex Europe B.V. | | | | | | | |
| Darwinweg 20, NL- 2333 CR Leiden, | | | | | | | |
| Nederland | | | | | | | |

—   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 |
| ------------------------------------------------------------------ | ----------------------------- | ---------------------------------------------------------------------------------------------------------- | ------------------------------------------------- | ------------------------------------------------------------------ |
| 2.10.2013 | Myocet | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, | | | | |
| Nederland | | | | |
| 2.10.2013 | Spedra | Menarini International Operations Luxembourg S.A. 1, avenue de la Gare - L-1611 Luxembourg | Menarini International Operations Luxembourg S.A. | 1, avenue de la Gare - L-1611 |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, avenue de la Gare - L-1611 | | | | |
| Luxembourg | | | | |
| 2.10.2013 | Zonegran | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, | | | | |
| United Kingdom | | | | |
| 4.10.2013 | ATryn | GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom | GTC Biotherapeutics UK Limited | 10 Norwich Street, London EC4A 1BD, |
| GTC Biotherapeutics UK Limited | | | | |
| 10 Norwich Street, London EC4A 1BD, | | | | |
| United Kingdom | | | | |
| 4.10.2013 | Ganfort | Allergan Pharmaceuticals Ireland, (514125) Castlebar Road, Westport, County Mayo, Ireland | Allergan Pharmaceuticals Ireland, (514125) | Castlebar Road, Westport, County Mayo, |
| Allergan Pharmaceuticals Ireland, (514125) | | | | |
| Castlebar Road, Westport, County Mayo, | | | | |
| Ireland | | | | |
| 9.10.2013 | Biograstim | AbZ-Pharma GmbH Graf -Arco-Straße 3, D-89079 Ulm, Deutschland | AbZ-Pharma GmbH | Graf -Arco-Straße 3, D-89079 Ulm, |
| AbZ-Pharma GmbH | | | | |
| Graf -Arco-Straße 3, D-89079 Ulm, | | | | |
| Deutschland | | | | |
| 9.10.2013 | Biopoin | Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | Teva GmbH | Graf-Arco-Straße 3, D-89079 Ulm, |
| Teva GmbH | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, | | | | |
| Deutschland | | | | |
| 9.10.2013 | Bridion | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, | | | | |
| United Kingdom | | | | |
| 9.10.2013 | Revestive | NPS Pharma Holdings Limited Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, Ireland | NPS Pharma Holdings Limited | Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, |
| NPS Pharma Holdings Limited | | | | |
| Grand Canal House, 1 Grand Canal Street Upper, Dublin 4, | | | | |
| Ireland | | | | |
| 11.10.2013 | Foscan | Biolitec Pharma Ltd United Drug House, Magna Drive, Dublin 24, Ireland | Biolitec Pharma Ltd | United Drug House, Magna Drive, Dublin 24, |
| Biolitec Pharma Ltd | | | | |
| United Drug House, Magna Drive, Dublin 24, | | | | |
| Ireland | | | | |
| 18.10.2013 | Cimzia | UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/09/544 | 22.10.2013 |
| 18.10.2013 | Viread | Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge CB21 6GT, |
| Gilead Sciences International Limited | | | | |
| Cambridge CB21 6GT, | | | | |
| United Kingdom | | | | |
| 24.10.2013 | ADCETRIS | Takeda Pharma A/S Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | Langebjerg 1, DK-4000 Roskilde, |
| Takeda Pharma A/S | | | | |
| Langebjerg 1, DK-4000 Roskilde, | | | | |
| Danmark | | | | |
| 24.10.2013 | Optaflu | Novartis Vaccines and Diagnostics GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | Novartis Vaccines and Diagnostics GmbH | Emil-von-Behring-Straße 76, D-35041 Marburg, |
| Novartis Vaccines and Diagnostics GmbH | | | | |
| Emil-von-Behring-Straße 76, D-35041 Marburg, | | | | |
| Deutschland | | | | |
| 31.10.2013 | Incivo | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, | | | | |
| België | | | | |
| 31.10.2013 | Incivo | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, | | | | |
| België | | | | |
| 31.10.2013 | Yervoy | Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | Bristol-Myers Squibb Pharma EEIG | Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, | | | | |
| United Kingdom | | | | |

—   Withdrawal of a marketing authorization (Article 13 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 |
| ------------------------- | ----------------------------- | -------------------------------------------------------------- | --------------------------------------------- | ------------------------- |
| 25.10.2013 | Clopidogrel ratiopharm | Archie Samuel s.r.o. Slunná 16, CZ-61700 Brno, Česká republika | Archie Samuel s.r.o. | Slunná 16, CZ-61700 Brno, |
| Archie Samuel s.r.o. | | | | |
| Slunná 16, CZ-61700 Brno, | | | | |
| Česká republika | | | | |

—   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 |
| ------------------------------------------ | ----------------------------- | ----------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------ |
| 11.10.2013 | 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, |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, | | | | |
| Belgique | | | | |
| 18.10.2013 | Advocate | Bayer Animal Health GmbH D-51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | D-51368 Leverkusen, |
| Bayer Animal Health GmbH | | | | |
| D-51368 Leverkusen, | | | | |
| Deutschland | | | | |

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 |

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

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