# C_2012371EN.01000701.xml

| 30.11.2012 | EN | Official Journal of the European Union | C 371/7 |
| ---------- | -- | -------------------------------------- | ------- |

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2012 to 31 October 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 371/03

—   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 |
| ----------------------------------------------------------- | ----------------------------- | ---------------------------------------- | ------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------- | ----------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------ |
| 23.10.2012 | XALKORI | crizotinib | Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | Pfizer Limited | Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | EU/1/12/793/001-004 | Capsule, hard |
| Pfizer Limited | | | | | | | |
| Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom | | | | | | | |
| 25.10.2012 | Adcetris | Brentuximab vedotin | 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 | EU/1/12/794/001 | powder for concentrate for solution for infusion |
| Takeda Global Research and Development Centre (Europe) Ltd. | | | | | | | |
| 61 Aldwych, London WC2B 4AE, United Kingdom | | | | | | | |
| 25.10.2012 | Glybera | Alipogene tiparvovec | uniQure biopharma B.V. Meibergdreef 61, 1105 BA Amsterdam, Nederland | uniQure biopharma B.V. | Meibergdreef 61, 1105 BA Amsterdam, Nederland | EU/1/12/791/001 | Solution for injection |
| uniQure biopharma B.V. | | | | | | | |
| Meibergdreef 61, 1105 BA Amsterdam, Nederland | | | | | | | |

—   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 |
| ------------------------------------------------------ | ----------------------------- | --------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------ |
| 25.10.2012 | Elelyso | 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 | | | | |

—   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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 1.10.2012 | 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 | | | | |
| 1.10.2012 | Conbriza | 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 | | | | |
| 1.10.2012 | Olanzapine Neopharma | Neopharma Limited 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | Neopharma Limited | 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom |
| Neopharma Limited | | | | |
| 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom | | | | |
| 1.10.2012 | 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 | | | | |
| 4.10.2012 | Cimzia | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | | | | |
| 4.10.2012 | Orencia | 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, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 4.10.2012 | Soliris | Alexion Europe S.A.S. 25, boulevard de l'Amiral Bruix, 75016 Paris, France | Alexion Europe S.A.S. | 25, boulevard de l'Amiral Bruix, 75016 Paris, France |
| Alexion Europe S.A.S. | | | | |
| 25, boulevard de l'Amiral Bruix, 75016 Paris, France | | | | |
| 4.10.2012 | Topotecan Eagle | Eagle Laboratories Limited The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM | Eagle Laboratories Limited | The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM |
| Eagle Laboratories Limited | | | | |
| The Clock House, Station Approach, Marlow, Bucks SL7 1NT, UNITED KINGDOM | | | | |
| 4.10.2012 | Vepacel | Baxter Innovations GmbH Industriestrasse 67, A – 1221 Vienna, Österreich | Baxter Innovations GmbH | Industriestrasse 67, A – 1221 Vienna, Österreich |
| Baxter Innovations GmbH | | | | |
| Industriestrasse 67, A – 1221 Vienna, Österreich | | | | |
| 8.10.2012 | Biograstim | CT Arzneimittel GmbH Graf-Arco-Strasse 3, 89079 Ulm, Deutschland | CT Arzneimittel GmbH | Graf-Arco-Strasse 3, 89079 Ulm, Deutschland |
| CT Arzneimittel GmbH | | | | |
| Graf-Arco-Strasse 3, 89079 Ulm, Deutschland | | | | |
| 8.10.2012 | Comtan | 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 | | | | |
| 8.10.2012 | DuoTrav | 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 | | | | |
| 8.10.2012 | Vidaza | Celgene Europe Ltd 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | Celgene Europe Ltd | 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom |
| Celgene Europe Ltd | | | | |
| 1 Longwalk Road, Stockley Park, Uxbridge, UB11 1DB, United Kingdom | | | | |
| 8.10.2012 | Zavesca | Actelion Registration Ltd. Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd. | Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom |
| Actelion Registration Ltd. | | | | |
| Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom | | | | |
| 10.10.2012 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 54, rue La Boétie, 75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54, rue La Boétie, 75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 10.10.2012 | Biopoin | CT Arzneimittel GmbH Graf-Arco-Strasse 3, 89079 Ulm, Deutschland | CT Arzneimittel GmbH | Graf-Arco-Strasse 3, 89079 Ulm, Deutschland |
| CT Arzneimittel GmbH | | | | |
| Graf-Arco-Strasse 3, 89079 Ulm, Deutschland | | | | |
| 10.10.2012 | Dynastat | 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 | | | | |
| 10.10.2012 | Emend | 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 | | | | |
| 10.10.2012 | Karvea | 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, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 10.10.2012 | Pylobactell | Torbet Laboratories Limited Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom | Torbet Laboratories Limited | Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom |
| Torbet Laboratories Limited | | | | |
| Unit 14D, Wendover Road, Rackheath Industrial Estate, Norwich, Norfolk NR13 6LH, United Kingdom | | | | |
| 10.10.2012 | Rapamune | 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 | | | | |
| 10.10.2012 | Synagis | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 15.10.2012 | Ceplene | Meda AB Box 906, SE 170 09 Solna, Sverige | Meda AB | Box 906, SE 170 09 Solna, Sverige |
| Meda AB | | | | |
| Box 906, SE 170 09 Solna, Sverige | | | | |
| 15.10.2012 | Clopidogrel 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 | | | | |
| 15.10.2012 | Olazax | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | | | | |
| 23.10.2012 | Alimta | 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 | | | | |
| 23.10.2012 | Glivec | 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 | | | | |
| 23.10.2012 | Helixate NexGen | Bayer Schering Pharma AG 13342 Berlin, Deutschland | Bayer Schering Pharma AG | 13342 Berlin, Deutschland |
| Bayer Schering Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 23.10.2012 | Humira | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 23.10.2012 | Kogenate Bayer | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 23.10.2012 | Nplate | Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, 4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, 4817 ZK Breda, Nederland | | | | |
| 23.10.2012 | NULOJIX | 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, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 23.10.2012 | Osseor | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, 92284 Suresnes cedex, France |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, 92284 Suresnes cedex, France | | | | |
| 23.10.2012 | Prolia | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 23.10.2012 | Protelos | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, 92284 Suresnes cedex, France |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, 92284 Suresnes cedex, France | | | | |
| 23.10.2012 | Telzir | ViiV Healthcare UK Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | ViiV Healthcare UK Ltd | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| ViiV Healthcare UK Ltd | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 23.10.2012 | Victoza | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 23.10.2012 | Visudyne | 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 | | | | |
| 24.10.2012 | Adenuric | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | | | | |
| 24.10.2012 | 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 |
| Roche Registration Limited | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | |
| 24.10.2012 | Baraclude | 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, United Kingdom |
| Bristol-Myers Squibb Pharma EEIG | | | | |
| Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | | | | |
| 24.10.2012 | Benlysta | 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 | | | | |
| 24.10.2012 | Brilique | AstraZeneca AB Södertälje S 151 85, Sverige | AstraZeneca AB | Södertälje S 151 85, Sverige |
| AstraZeneca AB | | | | |
| Södertälje S 151 85, Sverige | | | | |
| 24.10.2012 | ChondroCelect | TiGenix NV Romeinse straat 12/2, B-3001 LEUVEN, België | TiGenix NV | Romeinse straat 12/2, B-3001 LEUVEN, België |
| TiGenix NV | | | | |
| Romeinse straat 12/2, B-3001 LEUVEN, België | | | | |
| 24.10.2012 | 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 | | | | |
| 24.10.2012 | Clopidogrel HCS | HCS bvba H. Kennisstraat 53, B 2650 Edegem, Belgïe | HCS bvba | H. Kennisstraat 53, B 2650 Edegem, Belgïe |
| HCS bvba | | | | |
| H. Kennisstraat 53, B 2650 Edegem, Belgïe | | | | |
| 24.10.2012 | Daliresp | 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 | | | | |
| 24.10.2012 | Daxas | 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 | | | | |
| 24.10.2012 | Dynastat | 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 | | | | |
| 24.10.2012 | EDURANT | 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 | | | | |
| 24.10.2012 | Enbrel | 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 | | | | |
| 24.10.2012 | Eviplera | Gilead Sciences International Limited Cambridge, CB21 6GT, United Kingdom | Gilead Sciences International Limited | Cambridge, CB21 6GT, United Kingdom |
| Gilead Sciences International Limited | | | | |
| Cambridge, CB21 6GT, United Kingdom | | | | |
| 24.10.2012 | Exjade | 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 | | | | |
| 24.10.2012 | Ganfort | Allergan Pharmaceuticals Ireland Castlebar Road, Westport, Co. Mayo, Ireland | Allergan Pharmaceuticals Ireland | Castlebar Road, Westport, Co. Mayo, Ireland |
| Allergan Pharmaceuticals Ireland | | | | |
| Castlebar Road, Westport, Co. Mayo, Ireland | | | | |
| 24.10.2012 | Humira | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 24.10.2012 | Invirase | 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 | | | | |
| 24.10.2012 | Kinzalkomb | Bayer Pharma AG Berlin 13342, Deutschland | Bayer Pharma AG | Berlin 13342, Deutschland |
| Bayer Pharma AG | | | | |
| Berlin 13342, Deutschland | | | | |
| 24.10.2012 | 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 | | | | |
| 24.10.2012 | 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 | | | | |
| 24.10.2012 | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 24.10.2012 | Multaq | Sanofi 54, rue La Boétie, 75008 Paris, France | Sanofi | 54, rue La Boétie, 75008 Paris, France |
| Sanofi | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 24.10.2012 | Norvir | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 24.10.2012 | NovoSeven | Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark | Novo Nordisk A/S | Novo Allé, DK-2880 Bagsvaerd, Danmark |
| Novo Nordisk A/S | | | | |
| Novo Allé, DK-2880 Bagsvaerd, Danmark | | | | |
| 24.10.2012 | Onduarp | Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 24.10.2012 | Pandemrix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 24.10.2012 | Possia | AstraZeneca AB Södertälje S 151 85, Sverige | AstraZeneca AB | Södertälje S 151 85, Sverige |
| AstraZeneca AB | | | | |
| Södertälje S 151 85, Sverige | | | | |
| 24.10.2012 | PREZISTA | 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 | | | | |
| 24.10.2012 | PritorPlus | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 24.10.2012 | ReFacto AF | 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 | | | | |
| 24.10.2012 | RotaTeq | Sanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, France | Sanofi Pasteur MSD, SNC | 8, rue Jonas Salk, Lyon 69007, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8, rue Jonas Salk, Lyon 69007, France | | | | |
| 24.10.2012 | SonoVue | Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland | Bracco International B.V. | Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland |
| Bracco International B.V. | | | | |
| Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland | | | | |
| 24.10.2012 | Thymanax | Servier (Ireland) Industries Limited Gorey Road, Arklow, Co. Wicklow, Ireland | Servier (Ireland) Industries Limited | Gorey Road, Arklow, Co. Wicklow, Ireland |
| Servier (Ireland) Industries Limited | | | | |
| Gorey Road, Arklow, Co. Wicklow, Ireland | | | | |
| 24.10.2012 | Trajenta | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 24.10.2012 | Valdoxan | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, 92284 Suresnes cedex, France |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, 92284 Suresnes cedex, France | | | | |
| 24.10.2012 | Vimpat | UCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | UCB Pharma SA. | Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België |
| UCB Pharma SA. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België | | | | |
| 24.10.2012 | Votrient | 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 | | | | |
| 24.10.2012 | Zometa | 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 | | | | |
| 25.10.2012 | Bridion | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, 5349 AB Oss, Nederland |
| N.V. Organon | | | | |
| Kloosterstraat 6, 5349 AB Oss, Nederland | | | | |
| 25.10.2012 | Capecitabine 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 | | | | |
| 25.10.2012 | Cinryze | ViroPharma SPRL-BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | ViroPharma SPRL-BVBA | rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
| ViroPharma SPRL-BVBA | | | | |
| rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | | | | |
| 25.10.2012 | Clopidogrel Teva Pharma | 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 | | | | |
| 25.10.2012 | Copalia | 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 | | | | |
| 25.10.2012 | Corlentor | Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes, Cedex, France | Les Laboratoires Servier | 50 rue Carnot, 92284 Suresnes, Cedex, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, 92284 Suresnes, Cedex, France | | | | |
| 25.10.2012 | Dafiro | 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 | | | | |
| 25.10.2012 | Efavirenz Teva | Teva Pharma BV Computerweg 10, 3542 DR Utrecht, Nederland | Teva Pharma BV | Computerweg 10, 3542 DR Utrecht, Nederland |
| Teva Pharma BV | | | | |
| Computerweg 10, 3542 DR Utrecht, Nederland | | | | |
| 25.10.2012 | Eucreas | 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 | | | | |
| 25.10.2012 | Exforge HCT | 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 | | | | |
| 25.10.2012 | Fasturtec | Sanofi-aventis groupe 54, rue La Boétie, 75008 Paris, France | Sanofi-aventis groupe | 54, rue La Boétie, 75008 Paris, France |
| Sanofi-aventis groupe | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 25.10.2012 | Ferriprox | 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 | | | | |
| 25.10.2012 | Firazyr | Shire Orphan Therapies GmbH Friedrichstrasse 149, D-10117 Berlin, Deutschland | Shire Orphan Therapies GmbH | Friedrichstrasse 149, D-10117 Berlin, Deutschland |
| Shire Orphan Therapies GmbH | | | | |
| Friedrichstrasse 149, D-10117 Berlin, Deutschland | | | | |
| 25.10.2012 | Glidipion | Actavis Group PTC ehf. Reykjavíkurvegi 76 - 78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegi 76 - 78, 220 Hafnarfjörður, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegi 76 - 78, 220 Hafnarfjörður, Iceland | | | | |
| 25.10.2012 | Helicobacter test INFAI | INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH Universitätsstrasse 142, D - 44799 Bochum, Deutschland | INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH | Universitätsstrasse 142, D - 44799 Bochum, Deutschland |
| INFAI, Institut für biomedizinische Analytik & NMR Imaging GmbH | | | | |
| Universitätsstrasse 142, D - 44799 Bochum, Deutschland | | | | |
| 25.10.2012 | Humalog | 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 | | | | |
| 25.10.2012 | Incivo | 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 | | | | |
| 25.10.2012 | Instanyl | Nycomed Danmark ApS Langebjerg 1, DK-4000 Roskilde, Danmark | Nycomed Danmark ApS | Langebjerg 1, DK-4000 Roskilde, Danmark |
| Nycomed Danmark ApS | | | | |
| Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 25.10.2012 | Irbesartan 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 | | | | |
| 25.10.2012 | Isentress | Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | Merck Sharp & Dohme Limited | Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
| Merck Sharp & Dohme Limited | | | | |
| Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | | | | |
| 25.10.2012 | Jentadueto | Boehringer Ingelheim International GmbH Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim International GmbH | Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland | | | | |
| 25.10.2012 | Kaletra | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 25.10.2012 | Kepivance | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 25.10.2012 | Kineret | Swedish Orphan Biovitrum AB (publ) SE-112 76, Stockholm, Sverige | Swedish Orphan Biovitrum AB (publ) | SE-112 76, Stockholm, Sverige |
| Swedish Orphan Biovitrum AB (publ) | | | | |
| SE-112 76, Stockholm, Sverige | | | | |
| 25.10.2012 | Liprolog | 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 | | | | |
| 25.10.2012 | Olanzapine Glenmark | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | | | | |
| 25.10.2012 | Olanzapine Glenmark Europe | Glenmark Generics (Europe) Limited Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | Glenmark Generics (Europe) Limited | Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom |
| Glenmark Generics (Europe) Limited | | | | |
| Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom | | | | |
| 25.10.2012 | 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 |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | |
| 25.10.2012 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | Glenmark Pharmaceuticals s.r.o. | City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika |
| Glenmark Pharmaceuticals s.r.o. | | | | |
| City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika | | | | |
| 25.10.2012 | Procoralan | Les Laboratoires Servier 50, rue Carnot, 92284 Suresnes cedex, France | Les Laboratoires Servier | 50, rue Carnot, 92284 Suresnes cedex, France |
| Les Laboratoires Servier | | | | |
| 50, rue Carnot, 92284 Suresnes cedex, France | | | | |
| 25.10.2012 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | | | | |
| 25.10.2012 | Synflorix | 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 | | | | |
| 25.10.2012 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | medac Gesellschaft für klinische Spezialpräparate mbH | Fehlandtstrasse 3, D-20354 Hamburg - Deutschland |
| medac Gesellschaft für klinische Spezialpräparate mbH | | | | |
| Fehlandtstrasse 3, D-20354 Hamburg - Deutschland | | | | |
| 25.10.2012 | Temozolomide HEXAL | HEXAL AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland | HEXAL AG | Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
| HEXAL AG | | | | |
| Industriestrasse 25, D-83607 Holzkirchen, Deutschland | | | | |
| 25.10.2012 | Temozolomide Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | | | | |
| 25.10.2012 | Temozolomide SUN | Sun Pharmaceuticals Industries Europe B.V. Polarisavenue 87, 2132 JH Hoofddorp, Nederland | Sun Pharmaceuticals Industries Europe B.V. | Polarisavenue 87, 2132 JH Hoofddorp, Nederland |
| Sun Pharmaceuticals Industries Europe B.V. | | | | |
| Polarisavenue 87, 2132 JH Hoofddorp, Nederland | | | | |
| 25.10.2012 | Temozolomide Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 25.10.2012 | Topotecan Teva | Teva Pharma B.V. Computerweg 10, DR Utrecht 3542, Nederland | Teva Pharma B.V. | Computerweg 10, DR Utrecht 3542, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, DR Utrecht 3542, Nederland | | | | |
| 25.10.2012 | Toviaz | 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 | | | | |
| 25.10.2012 | Tracleer | Actelion Registration Ltd Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | Actelion Registration Ltd | Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
| Actelion Registration Ltd | | | | |
| Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | | | | |
| 25.10.2012 | Tredaptive | 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 | | | | |
| 25.10.2012 | Trevaclyn | 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 | | | | |
| 25.10.2012 | Twynsta | 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 |
| Boehringer Ingelheim International GmbH | | | | |
| Binger Strasse 173 - D - 55216 Ingelheim am Rhein, Deutschland | | | | |
| 25.10.2012 | Vectibix | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 29.10.2012 | Advagraf | Astellas Pharma Europe B.V. Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, NL-2353 EW Leiderdorp, Nederland | | | | |
| 29.10.2012 | Aranesp | Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland | Amgen Europe B.V. | Minervum 7061, NL-4817 ZK Breda, Nederland |
| Amgen Europe B.V. | | | | |
| Minervum 7061, NL-4817 ZK Breda, Nederland | | | | |
| 29.10.2012 | ATryn | GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom | GTC Biotherapeutics UK Limited | 10 Norwich Street, London EC4A 1BD, United Kingdom |
| GTC Biotherapeutics UK Limited | | | | |
| 10 Norwich Street, London EC4A 1BD, United Kingdom | | | | |
| 29.10.2012 | Biograstim | CT Arzneimittel GmbH Graf-Arco-Strasse 3, 89079 Ulm, Deutschland | CT Arzneimittel GmbH | Graf-Arco-Strasse 3, 89079 Ulm, Deutschland |
| CT Arzneimittel GmbH | | | | |
| Graf-Arco-Strasse 3, 89079 Ulm, Deutschland | | | | |
| 29.10.2012 | Bronchitol | Pharmaxis Pharmaceuticals Limited The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom | Pharmaxis Pharmaceuticals Limited | The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom |
| Pharmaxis Pharmaceuticals Limited | | | | |
| The Priory, Stomp Road, Burnham, Buckinghamshire, SL1 7LW, United Kingdom | | | | |
| 29.10.2012 | Byetta | 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 | | | | |
| 29.10.2012 | Caelyx | 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 | | | | |
| 29.10.2012 | CANCIDAS | 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 | | | | |
| 29.10.2012 | Dificlir | Astellas Pharma Europe B.V. Elisabethhof 19, 2353 EW Leiderdorp, Nederland | Astellas Pharma Europe B.V. | Elisabethhof 19, 2353 EW Leiderdorp, Nederland |
| Astellas Pharma Europe B.V. | | | | |
| Elisabethhof 19, 2353 EW Leiderdorp, Nederland | | | | |
| 29.10.2012 | Docetaxel Mylan | Mylan S.A.S 117 allée des Parcs, 69 800 Saint Priest, France | Mylan S.A.S | 117 allée des Parcs, 69 800 Saint Priest, France |
| Mylan S.A.S | | | | |
| 117 allée des Parcs, 69 800 Saint Priest, France | | | | |
| 29.10.2012 | Esbriet | InterMune UK Ltd Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom | InterMune UK Ltd | Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom |
| InterMune UK Ltd | | | | |
| Euston Tower, Floor 32, 286 Euston Road, London, NW1 3DP, United Kingdom | | | | |
| 29.10.2012 | Exforge | 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 | | | | |
| 29.10.2012 | Firdapse | BioMarin Europe Ltd 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | BioMarin Europe Ltd | 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom |
| BioMarin Europe Ltd | | | | |
| 164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | | | | |
| 29.10.2012 | Foscan | Biolitec pharma Ltd United Drug House, Magna Drive, Dublin 24, Ireland | Biolitec pharma Ltd | United Drug House, Magna Drive, Dublin 24, Ireland |
| Biolitec pharma Ltd | | | | |
| United Drug House, Magna Drive, Dublin 24, Ireland | | | | |
| 29.10.2012 | Fycompa | Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom | Eisai Europe Limited | European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom |
| Eisai Europe Limited | | | | |
| European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom | | | | |
| 29.10.2012 | Ibandronic Acid 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 | | | | |
| 29.10.2012 | Icandra | 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 | | | | |
| 29.10.2012 | Imprida | 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 | | | | |
| 29.10.2012 | INOmax | INO Therapeutics AB SE-181 81 Lidingö, Sverige | INO Therapeutics AB | SE-181 81 Lidingö, Sverige |
| INO Therapeutics AB | | | | |
| SE-181 81 Lidingö, Sverige | | | | |
| 29.10.2012 | Irbesartan/Hydrochlorothiazide 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 | | | | |
| 29.10.2012 | Javlor | Pierre Fabre Médicament 45, place Abel Gance, F-92100 Boulogne, France | Pierre Fabre Médicament | 45, place Abel Gance, F-92100 Boulogne, France |
| Pierre Fabre Médicament | | | | |
| 45, place Abel Gance, F-92100 Boulogne, France | | | | |
| 29.10.2012 | Leflunomide 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 | | | | |
| 29.10.2012 | Levetiracetam Actavis Group | Actavis Group PTC ehf. ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | Actavis Group PTC ehf. | ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland |
| Actavis Group PTC ehf. | | | | |
| ReykjavÍkurvegur 76-78, Hafnarfjörður 220, Iceland | | | | |
| 29.10.2012 | Lucentis | 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 | | | | |
| 29.10.2012 | Myclausen | Herbert J. Passauer GmbH & Co. KG Stubenrauchstrasse 33, 14167 Berlin, Deutschland | Herbert J. Passauer GmbH & Co. KG | Stubenrauchstrasse 33, 14167 Berlin, Deutschland |
| Herbert J. Passauer GmbH & Co. KG | | | | |
| Stubenrauchstrasse 33, 14167 Berlin, Deutschland | | | | |
| 29.10.2012 | Myocet | Cephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, France | Cephalon Europe | 5 Rue Charles Martigny, Maisons Alfort 94700, France |
| Cephalon Europe | | | | |
| 5 Rue Charles Martigny, Maisons Alfort 94700, France | | | | |
| 29.10.2012 | Nimvastid | 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 | | | | |
| 29.10.2012 | Pelzont | 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 | | | | |
| 29.10.2012 | Pixuvri | CTI Life Sciences Ltd Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | CTI Life Sciences Ltd | Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom |
| CTI Life Sciences Ltd | | | | |
| Biopark, Broadwater Road, Welwyn Garden City, Hertfordshire AL73AX, United Kingdom | | | | |
| 29.10.2012 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 54, rue La Boétie, 75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54, rue La Boétie, 75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54, rue La Boétie, 75008 Paris, France | | | | |
| 29.10.2012 | Plenadren | ViroPharma SPRL Rue Montoyer 47, 1000 Bruxelles/Brussel, Belgique/België | ViroPharma SPRL | Rue Montoyer 47, 1000 Bruxelles/Brussel, Belgique/België |
| ViroPharma SPRL | | | | |
| Rue Montoyer 47, 1000 Bruxelles/Brussel, Belgique/België | | | | |
| 29.10.2012 | Pravafenix | LABORATOIRES SMB SA 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique/26-28 Herdersliedstraat, 1080 Brussel, België | LABORATOIRES SMB SA | 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique/26-28 Herdersliedstraat, 1080 Brussel, België |
| LABORATOIRES SMB SA | | | | |
| 26-28 rue de la Pastorale, 1080 Bruxelles, Belgique/26-28 Herdersliedstraat, 1080 Brussel, België | | | | |
| 29.10.2012 | Pumarix | GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, Rixensart, B-1330 Belgique | GlaxoSmithKline Biologicals S.A. | rue de l'Institut 89, Rixensart, B-1330 Belgique |
| GlaxoSmithKline Biologicals S.A. | | | | |
| rue de l'Institut 89, Rixensart, B-1330 Belgique | | | | |
| 29.10.2012 | Raloxifene 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 | | | | |
| 29.10.2012 | Ranexa | Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | Menarini International Operations Luxembourg S.A. | 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg |
| Menarini International Operations Luxembourg S.A. | | | | |
| 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg | | | | |
| 29.10.2012 | Rapiscan | Rapidscan Pharma Solutions EU Ltd. Regent's Place, 338 Euston Road, London NW1 3BT, UK | Rapidscan Pharma Solutions EU Ltd. | Regent's Place, 338 Euston Road, London NW1 3BT, UK |
| Rapidscan Pharma Solutions EU Ltd. | | | | |
| Regent's Place, 338 Euston Road, London NW1 3BT, UK | | | | |
| 29.10.2012 | Repaglinide 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 | | | | |
| 29.10.2012 | Repaglinide 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 | | | | |
| 29.10.2012 | Repso | 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 | | | | |
| 29.10.2012 | Ribavirin 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 |
| Generics [UK] Limited | | | | |
| Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | | | | |
| 29.10.2012 | Rienso | 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 | | | | |
| 29.10.2012 | Sabervel | 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 | | | | |
| 29.10.2012 | Samsca | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom | | | | |
| 29.10.2012 | Stelara | 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 | | | | |
| 29.10.2012 | Sycrest | N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland | N.V. Organon | Kloosterstraat 6, 5349 AB Oss, Nederland |
| N.V. Organon | | | | |
| Kloosterstraat 6, 5349 AB Oss, Nederland | | | | |
| 29.10.2012 | Tasmar | Meda AB Pipers väg 2A, SE-170 73 Solna, Sverige | Meda AB | Pipers väg 2A, SE-170 73 Solna, Sverige |
| Meda AB | | | | |
| Pipers väg 2A, SE-170 73 Solna, Sverige | | | | |
| 29.10.2012 | Telmisartan Actavis | Actavis Group PTC ehf. Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland | Actavis Group PTC ehf. | Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland | | | | |
| 29.10.2012 | Telmisartan 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 | | | | |
| 29.10.2012 | Telmisartan Teva Pharma | 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 | | | | |
| 29.10.2012 | Teysuno | Nordic Group BV Siriusdreef 22, 2132 WT Hoofddorp, Nederland | Nordic Group BV | Siriusdreef 22, 2132 WT Hoofddorp, Nederland |
| Nordic Group BV | | | | |
| Siriusdreef 22, 2132 WT Hoofddorp, Nederland | | | | |
| 29.10.2012 | Topotecan Hospira | Hospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | Hospira UK Limited | Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom |
| Hospira UK Limited | | | | |
| Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | | | | |
| 29.10.2012 | Vfend | 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 | | | | |
| 29.10.2012 | Xarelto | Bayer Pharma AG 13342 Berlin, Deutschland | Bayer Pharma AG | 13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| 13342 Berlin, Deutschland | | | | |
| 29.10.2012 | Zalasta | 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 | | | | |
| 29.10.2012 | Zomarist | 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 | | | | |
| 31.10.2012 | Adjupanrix | 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 | | | | |
| 31.10.2012 | Axura | Merz Pharmaceuticals GmbH Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | Merz Pharmaceuticals GmbH | Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland |
| Merz Pharmaceuticals GmbH | | | | |
| Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland | | | | |
| 31.10.2012 | Copalia HCT | 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 | | | | |
| 31.10.2012 | Dafiro HCT | 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 | | | | |
| 31.10.2012 | Docetaxel Winthrop | Aventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, France | Aventis Pharma S.A. | 20 avenue Raymond Aron, F-92165 Antony Cedex, France |
| Aventis Pharma S.A. | | | | |
| 20 avenue Raymond Aron, F-92165 Antony Cedex, France | | | | |
| 31.10.2012 | Ebixa | H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark | H. Lundbeck A/S | Ottiliavej 9, DK-2500 Valby, Danmark |
| H. Lundbeck A/S | | | | |
| Ottiliavej 9, DK-2500 Valby, Danmark | | | | |
| 31.10.2012 | Ifirmasta | 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 | | | | |
| 31.10.2012 | Kaletra | AbbVie Ltd. Maidenhead, SL6 4XE, United Kingdom | AbbVie Ltd. | Maidenhead, SL6 4XE, United Kingdom |
| AbbVie Ltd. | | | | |
| Maidenhead, SL6 4XE, United Kingdom | | | | |
| 31.10.2012 | Kiovig | Baxter AG Industriestraße 67, A - 1221 Wien, Österreich | Baxter AG | Industriestraße 67, A - 1221 Wien, Österreich |
| Baxter AG | | | | |
| Industriestraße 67, A - 1221 Wien, Österreich | | | | |
| 31.10.2012 | 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 | | | | |
| 31.10.2012 | Levetiracetam Actavis | Actavis Group PTC ehf. Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland | Actavis Group PTC ehf. | Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland |
| Actavis Group PTC ehf. | | | | |
| Reykjavikurvegur 76-78, 220 Hafnarfjordur, Iceland | | | | |
| 31.10.2012 | Ratiograstim | 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 | | | | |
| 31.10.2012 | Repaglinide Accord | 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 |
| Accord Healthcare Limited | | | | |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF United Kingdom | | | | |
| 31.10.2012 | Rivastigmine Sandoz | Sandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | Sandoz Pharmaceuticals GmbH | Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland |
| Sandoz Pharmaceuticals GmbH | | | | |
| Raiffeisenstraße 11, 83607 Holzkirchen, Deutschland | | | | |
| 31.10.2012 | Siklos | ADDMEDICA 101, rue Saint Lazare, Paris 75009, France | ADDMEDICA | 101, rue Saint Lazare, Paris 75009, France |
| ADDMEDICA | | | | |
| 101, rue Saint Lazare, Paris 75009, France | | | | |
| 31.10.2012 | Tevagrastim | Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland | Teva GmbH | Graf-Arco-Straße 3, 89079 Ulm, Deutschland |
| Teva GmbH | | | | |
| Graf-Arco-Straße 3, 89079 Ulm, Deutschland | | | | |
| 31.10.2012 | Tolura | 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 | | | | |
| 31.10.2012 | Votubia | 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 | | | | |

—   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 |
| ------------------------------------------------ | ----------------------------- | ------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------ |
| 4.10.2012 | Daliresp | 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 | | | | |
| 4.10.2012 | Daxas | 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 |
| ---------------------------------------------- | ----------------------------- | ------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------- |
| 24.10.2012 | Rilonacept Regeneron | Regeneron UK Limited 40 Bank Street, E14 5DS London, United Kingdom | Regeneron UK Limited | 40 Bank Street, E14 5DS London, United Kingdom |
| Regeneron UK Limited | | | | |
| 40 Bank Street, E14 5DS London, United Kingdom | | | | |

—   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 |
| ------------------------------------------------------------------------------------------------ | ----------------------------- | ---------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ------------------------------------------------------------------------------------------------ |
| 10.10.2012 | Acticam | Ecuphar NV Legeweg 157-I, B-8020 Oostkamp, Belgïe | Ecuphar NV | Legeweg 157-I, B-8020 Oostkamp, Belgïe |
| Ecuphar NV | | | | |
| Legeweg 157-I, B-8020 Oostkamp, Belgïe | | | | |
| 15.10.2012 | Oxyglobin | OPK Biotech Netherlands BV Teleportboulevard 140, 1043EJ Amsterdam, Nederland | OPK Biotech Netherlands BV | Teleportboulevard 140, 1043EJ Amsterdam, Nederland |
| OPK Biotech Netherlands BV | | | | |
| Teleportboulevard 140, 1043EJ Amsterdam, Nederland | | | | |
| 23.10.2012 | ProteqFlu | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, 69007 Lyon, France |
| Merial | | | | |
| 29 Avenue Tony Garnier, 69007 Lyon, France | | | | |
| 24.10.2012 | Pirsue | 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 | | | | |
| 25.10.2012 | Dexdomitor | Orion Corporation Orionintie 1, FIN-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FIN-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FIN-02200 Espoo, Suomi | | | | |
| 25.10.2012 | Posatex | 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 | | | | |
| 25.10.2012 | Stronghold | 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 | | | | |
| 29.10.2012 | Improvac | 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 | | | | |
| 29.10.2012 | Loxicom | Norbrook Laboratories Limited Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | Norbrook Laboratories Limited | Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |
| Norbrook Laboratories Limited | | | | |
| Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | | | | |
| 29.10.2012 | Meloxidyl | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, 33500 Libourne, France |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, 33500 Libourne, France | | | | |
| 29.10.2012 | Previcox | Merial 29 Avenue Tony Garnier, 69007 Lyon, France | Merial | 29 Avenue Tony Garnier, 69007 Lyon, France |
| Merial | | | | |
| 29 Avenue Tony Garnier, 69007 Lyon, France | | | | |
| 29.10.2012 | Procox | Bayer Animal Health GmbH 51368 Leverkusen, Deutschland | Bayer Animal Health GmbH | 51368 Leverkusen, Deutschland |
| Bayer Animal Health GmbH | | | | |
| 51368 Leverkusen, Deutschland | | | | |
| 29.10.2012 | RevitaCAM | 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 | | | | |
| 29.10.2012 | Suvaxyn PCV | 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 | | | | |
| 31.10.2012 | PRILACTONE | CEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, France | CEVA SANTE ANIMALE | 10 avenue de la Ballastière, 33500 Libourne, France |
| CEVA SANTE ANIMALE | | | | |
| 10 avenue de la Ballastière, 33500 Libourne, France | | | | |

—   Lift of suspension of a marketing authorization (Article 45 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 |
| ----------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 10.10.2012 | Suvaxyn PCV | 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 | | | | |

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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