# C_2012328EN.01000101.xml

| 26.10.2012 | EN | Official Journal of the European Union | C 328/1 |
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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2012 to 30 September 2012

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

2012/C 328/01

—   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 |
| ---------------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------ |
| 3.9.2012 | Inlyta | Axitinib | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | EU/1/12/777/001-006 | Film-coated tablet |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | | | | |
| 3.9.2012 | NovoThirteen | catridecacog | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/775/001 | Powder and solvent for solution for injection |
| Novo Nordisk A/S | | | | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | | | | |
| 20.9.2012 | Dacogen | Decitabine | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792/001 | powder for concentrate for solution for infusion |
| Janssen-Cilag International NV | | | | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | | | | |
| 28.9.2012 | Enurev Breezhaler | glycopyrronium bromide | 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/1/12/789/001-006 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |
| 28.9.2012 | Seebri Breezhaler | glycopyrronium bromide | 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/1/12/788/001-006 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |
| 28.9.2012 | Tovanor Breezhaler | glycopyrronium bromide | 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/1/12/790/001-006 | Inhalation powder, hard capsule |
| Novartis Europharm Limited | | | | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | | | | |

—   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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 10.9.2012 | Advate | Baxter AG Industriesstrasse 67, 1221 Wien, Österreich | Baxter AG | Industriesstrasse 67, 1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriesstrasse 67, 1221 Wien, Österreich | | | | |
| 10.9.2012 | Cialis | Eli Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, 3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, 3991 RA Houten, Nederland | | | | |
| 10.9.2012 | Entacapone Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 10.9.2012 | JEVTANA | Sanofi-aventis groupe 54, rue de la Boétie, F-75008 France | Sanofi-aventis groupe | 54, rue de la Boétie, F-75008 France |
| Sanofi-aventis groupe | | | | |
| 54, rue de la Boétie, F-75008 France | | | | |
| 10.9.2012 | Levetiracetam ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | |
| 10.9.2012 | Norvir | Abbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | Abbott Laboratories Ltd | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom |
| Abbott Laboratories Ltd | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom | | | | |
| 10.9.2012 | Orgalutran | N.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland | N.V. Organon | P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland |
| N.V. Organon | | | | |
| P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, Nederland | | | | |
| 10.9.2012 | Ozurdex | Allergan Pharmaceuticals (Ireland) Ltd Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals (Ireland) Ltd | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals (Ireland) Ltd | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 10.9.2012 | Rasilamlo | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | |
| 10.9.2012 | Rasitrio | Novartis Europharm Limited Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | Novartis Europharm Limited | Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom |
| Novartis Europharm Limited | | | | |
| Wimblehurst Road, Horsham, West Sussex, RH12 5AB, United Kingdom | | | | |
| 10.9.2012 | Revlimid | Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom | Celgene Europe Limited | 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom |
| Celgene Europe Limited | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex, UB11 1DB, United Kingdom | | | | |
| 10.9.2012 | Sildenafil Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 10.9.2012 | Simponi | Janssen Biologics B.V. Einsteinweg 101, CB Leiden 2333, Nederland | Janssen Biologics B.V. | Einsteinweg 101, CB Leiden 2333, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, CB Leiden 2333, Nederland | | | | |
| 10.9.2012 | Somavert | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 10.9.2012 | Tamiflu | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 10.9.2012 | Trobalt | Glaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | Glaxo Group Limited | Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom |
| Glaxo Group Limited | | | | |
| Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 10.9.2012 | Xelevia | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 11.9.2012 | Clopidogrel ratiopharm | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 11.9.2012 | Docetaxel Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 12.9.2012 | Clopidogrel Krka | KRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d. d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d. d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 12.9.2012 | Clopidogrel Krka d.d. | KRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija | KRKA, d.d., Novo mesto | Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
| KRKA, d.d., Novo mesto | | | | |
| Šmarješka cesta 6, 8501 Novo mesto, Slovenija | | | | |
| 12.9.2012 | Clopidogrel TAD | TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland | TAD Pharma GmbH | Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland |
| TAD Pharma GmbH | | | | |
| Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland | | | | |
| 17.9.2012 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | Bristol-Myers Squibb and Gilead Sciences Limited | IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland |
| Bristol-Myers Squibb and Gilead Sciences Limited | | | | |
| IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | | | | |
| 17.9.2012 | Cervarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, 1330 Rixensart, Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, 1330 Rixensart, Belgique | | | | |
| 17.9.2012 | Clopidogrel ratiopharm GmbH | Acino Pharma GmbH Am Windfeld 35, 83714 Miesbach, Deutschland | Acino Pharma GmbH | Am Windfeld 35, 83714 Miesbach, Deutschland |
| Acino Pharma GmbH | | | | |
| Am Windfeld 35, 83714 Miesbach, Deutschland | | | | |
| 17.9.2012 | Glubrava | Takeda Global Research and Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United Kingdom | Takeda Global Research and Development Centre (Europe) Ltd | 61 Aldwych, London WC2B 4AE, United Kingdom |
| Takeda Global Research and Development Centre (Europe) Ltd | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | |
| 17.9.2012 | Levetiracetam Accord | Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom | Accord Healthcare Limited | 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom |
| Accord Healthcare Limited | | | | |
| 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom | | | | |
| 17.9.2012 | Replagal | Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, 182 33 Danderyd, Sverige |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, 182 33 Danderyd, Sverige | | | | |
| 20.9.2012 | Azarga | Alcon Laboratories (UK) Ltd. Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | | | | |
| 20.9.2012 | Leflunomide ratiopharm | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
| ratiopharm GmbH | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | |
| 20.9.2012 | Mircera | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 20.9.2012 | Olanzapine Apotex | Apotex Europe B.V. Darwingweg 20, 2333 CR Leiden, Nederland | Apotex Europe B.V. | Darwingweg 20, 2333 CR Leiden, Nederland |
| Apotex Europe B.V. | | | | |
| Darwingweg 20, 2333 CR Leiden, Nederland | | | | |
| 20.9.2012 | 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, Deutschland |
| Novartis Vaccines and Diagnostics GmbH | | | | |
| Emil-von-Behring-Strasse 76, D-35041 Marburg, Deutschland | | | | |
| 20.9.2012 | Prialt | Eisai Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom | Eisai Limited | European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom |
| Eisai Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom | | | | |
| 20.9.2012 | Sutent | Pfizer Ltd Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | Pfizer Ltd | Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom |
| Pfizer Ltd | | | | |
| Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom | | | | |
| 20.9.2012 | Tasigna | Novartis Europharm Ltd Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | Novartis Europharm Ltd | Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom |
| Novartis Europharm Ltd | | | | |
| Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | | | | |
| 20.9.2012 | Tesavel | Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Ltd | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Ltd | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 20.9.2012 | Torisel | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 20.9.2012 | VELCADE | Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België | Janssen-Cilag International NV | Turnhoutseweg 30, B-2340 Beerse, België |
| Janssen-Cilag International NV | | | | |
| Turnhoutseweg 30, B-2340 Beerse, België | | | | |
| 20.9.2012 | Xeloda | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 24.9.2012 | alli | 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 |
| Glaxo Group Limited | | | | |
| Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom | | | | |
| 24.9.2012 | Elaprase | Shire Human Genetic Therapies AB Svärdvägen 11D, 182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, 182 33 Danderyd, Sverige |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, 182 33 Danderyd, Sverige | | | | |
| 24.9.2012 | Komboglyze | Bristol Myers Squibb/AstraZeneca EEIG Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | Bristol Myers Squibb/AstraZeneca EEIG | Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom |
| Bristol Myers Squibb/AstraZeneca EEIG | | | | |
| Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | | | | |
| 24.9.2012 | Nevanac | Alcon Laboratories (UK) Ltd. Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | Alcon Laboratories (UK) Ltd. | Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom |
| Alcon Laboratories (UK) Ltd. | | | | |
| Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom | | | | |
| 24.9.2012 | PecFent | Archimedes Development Ltd Nottingham, NGT7 2TN, United Kingdom | Archimedes Development Ltd | Nottingham, NGT7 2TN, United Kingdom |
| Archimedes Development Ltd | | | | |
| Nottingham, NGT7 2TN, United Kingdom | | | | |
| 24.9.2012 | Pramipexole Accord | Accord Healthcare Limited 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom | Accord Healthcare Limited | 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom |
| Accord Healthcare Limited | | | | |
| 5th Floor Charles House, 108/110 Finchley road, London NW3 5JJ, United Kingdom | | | | |
| 24.9.2012 | Revasc | Canyon Pharmaceuticals Ltd 7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom | Canyon Pharmaceuticals Ltd | 7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom |
| Canyon Pharmaceuticals Ltd | | | | |
| 7th Floor, 52-54 Gracechurch Street, London EC3V OEH, United Kingdom | | | | |
| 24.9.2012 | Torisel | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 24.9.2012 | Xenical | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 28.9.2012 | Irbesartan Zentiva | Sanofi 54, rue La Boétie, 75008 Paris, France | Sanofi | 54, rue La Boétie, 75008 Paris, France |
| Sanofi | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 28.9.2012 | Matever | Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | Pharmathen S.A. | 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
| Pharmathen S.A. | | | | |
| 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | | | | |
| 28.9.2012 | Pegasys | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |

—   Modification 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 |
| ------------------------------------------------ | ----------------------------- | ------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------ |
| 28.9.2012 | Libertek | Nycomed GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | Nycomed GmbH | Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland |
| Nycomed GmbH | | | | |
| Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | | | | |

—   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 |
| ------------------------------------------ | ----------------------------- | ----------------------------------------------------------- | --------------------------------------------- | ------------------------------------------ |
| 10.9.2012 | Rivastigmine Teva | Teva Pharma B.V. Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------ | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------------------------------------ |
| 3.9.2012 | BTVPUR AlSap 8 | MERIAL 29 avenue Tony Garnier, 69007 LYON, France | MERIAL | 29 avenue Tony Garnier, 69007 LYON, France |
| MERIAL | | | | |
| 29 avenue Tony Garnier, 69007 LYON, France | | | | |
| 10.9.2012 | TruScient | Pfizer Limited Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom |
| Pfizer Limited | | | | |
| Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom | | | | |
| 10.9.2012 | Veraflox | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, Deutschland |
| Bayer Animal Health GmbH | | | | |
| 51368 Leverkusen, Deutschland | | | | |
| 11.9.2012 | Porcilis PCV | Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland | | | | |
| 28.9.2012 | SevoFlo | Abbott Laboratories Limited Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM | Abbott Laboratories Limited | Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM |
| Abbott Laboratories Limited | | | | |
| Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM | | | | |

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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