# C_2013250EN.01003001.xml

| 30.8.2013 | EN | Official Journal of the European Union | C 250/30 |
| --------- | -- | -------------------------------------- | -------- |

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

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

2013/C 250/02

—   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 |
| ---------------------------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------------------------- | ----------------------------------------------- | ------------------------------------------------------------- |
| 13.6.2013 | Memantine ratiopharm | memantine | ratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | ratiopharm GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/13/836 | Film-coated tablet |
| ratiopharm GmbH | | | | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | | | | |
| 14.6.2013 | Votrient | Pazopanib hydrochloride | Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Limited | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/10/628 | Film-coated tablet |
| Glaxo Group Limited | | | | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | | | | |
| 21.6.2013 | Capecitabine SUN | Capecitabine | Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | Sun Pharmaceutical Industries Europe BV | Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | Film-coated tablet |
| Sun Pharmaceutical Industries Europe BV | | | | | | | |
| Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | | | | | | | |
| 21.6.2013 | Spedra | avanafil | VIVUS B.V. Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | VIVUS B.V. | Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | EU/1/13/841 | Tablet |
| VIVUS B.V. | | | | | | | |
| Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland | | | | | | | |
| 21.6.2013 | Xtandi | enzalutamide | Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland | Astellas Pharma Europe B.V. | Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | Capsule, soft |
| Astellas Pharma Europe B.V. | | | | | | | |
| Sylviusweg 62, NL-2333 BE Leiden, Nederland | | | | | | | |
| 24.6.2013 | Nuedexta | Dextromethorphan/quinidine | Jenson Pharmaceutical Services Ltd Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom | Jenson Pharmaceutical Services Ltd | Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom | EU/1/13/833 | Capsule, hard |
| Jenson Pharmaceutical Services Ltd | | | | | | | |
| Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom | | | | | | | |
| 24.6.2013 | Stayveer | bosentan | Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | Marklas Nederland B.V. | Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | Film-coated tablet |
| Marklas Nederland B.V. | | | | | | | |
| Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | | | | | | | |
| 27.6.2013 | MACI | Matrix applied characterised autologous cultured chondrocytes | Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland | Genzyme Europe B.V. | Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/13/847 | Implantation matrix |
| Genzyme Europe B.V. | | | | | | | |
| Gooimeer 10, NL-1411 DD Naarden, Nederland | | | | | | | |
| 1.7.2013 | Iclusig | ponatinib | ARIAD Pharma Ltd 2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom | ARIAD Pharma Ltd | 2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom | EU/1/13/839 | Film-coated tablet |
| ARIAD Pharma Ltd | | | | | | | |
| 2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom | | | | | | | |
| 1.7.2013 | Imatinib Accord | Imatinib | Accord Healthcare Limited Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom | Accord Healthcare Limited | Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom | EU/1/13/845 | Film-coated tablet |
| Accord Healthcare Limited | | | | | | | |
| Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom | | | | | | | |
| 12.7.2013 | Erivedge | vismodegib | Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | Roche Registration Limited | 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/848 | Capsule, hard |
| Roche Registration Limited | | | | | | | |
| 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | | | | | | | |
| 25.7.2013 | Lonquex | lipegfilgrastim | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/13/856 | Solution for injection |
| Teva Pharma B.V. | | | | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | | | | |
| 31.7.2013 | Atosiban SUN | atosiban | Sun Pharmaceutical Industries Europe BV Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | Sun Pharmaceutical Industries Europe BV | Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/852 | Concentrate for solution for infusion
Solution for injection |
| Sun Pharmaceutical Industries Europe BV | | | | | | | |
| Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | | | | | | | |
| 31.7.2013 | Imvanex | modified vaccinia ankara virus | Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | Bavarian Nordic A/S | Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | EU/1/13/855 | Suspension for injection |
| Bavarian Nordic A/S | | | | | | | |
| Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | | | | | | | |
| 31.7.2013 | Lojuxta | Lomitapide | Aegerion Pharmaceuticals 37/39 avenue Ledru Rollin, F-75012 Paris, France | Aegerion Pharmaceuticals | 37/39 avenue Ledru Rollin, F-75012 Paris, France | EU/1/13/851 | Capsule, hard |
| Aegerion Pharmaceuticals | | | | | | | |
| 37/39 avenue Ledru Rollin, F-75012 Paris, France | | | | | | | |
| 31.7.2013 | PHEBURANE | Sodium Phenylbutyrate | Lucane Pharma 172 rue de Charonne, 75011 Paris, France | Lucane Pharma | 172 rue de Charonne, 75011 Paris, France | EU/1/13/822/ | Granules |
| Lucane Pharma | | | | | | | |
| 172 rue de Charonne, 75011 Paris, France | | | | | | | |

—   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 |
| --------------------------------------------------------------------------------------------------------------- | ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
| 11.6.2013 | IOA | Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland | Organon N.V. | Kloosterstraat 6, NL-5349 AB Oss, Nederland |
| Organon N.V. | | | | |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland | | | | |
| 11.6.2013 | Rienso | Takeda Pharma A/S PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | Takeda Pharma A/S | PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark |
| Takeda Pharma A/S | | | | |
| PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | | | | |
| 11.6.2013 | Zoely | Theramex S.r.l. Via Messina 38, 20154 Milano, Italia | Theramex S.r.l. | Via Messina 38, 20154 Milano, Italia |
| Theramex S.r.l. | | | | |
| Via Messina 38, 20154 Milano, Italia | | | | |
| 13.6.2013 | Abilify | Otsuka Pharmaceutical Europe Ltd Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. | Otsuka Pharmaceutical Europe Ltd | Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. |
| Otsuka Pharmaceutical Europe Ltd | | | | |
| Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom. | | | | |
| 13.6.2013 | 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 | | | | |
| 13.6.2013 | 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 | | | | |
| 13.6.2013 | Tysabri | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
| Biogen Idec Limited | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | |
| 21.6.2013 | Bridion | Organon N.V. Kloosterstraat 6, NL-5349 AB Oss, Nederland | Organon N.V. | Kloosterstraat 6, NL-5349 AB Oss, Nederland |
| Organon N.V. | | | | |
| Kloosterstraat 6, NL-5349 AB Oss, Nederland | | | | |
| 21.6.2013 | Brinavess | Cardiome UK Limited Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom | Cardiome UK Limited | Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom |
| Cardiome UK Limited | | | | |
| Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom | | | | |
| 21.6.2013 | 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 | | | | |
| 21.6.2013 | 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 | | | | |
| 21.6.2013 | Intelence | 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 | | | | |
| 21.6.2013 | 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 | | | | |
| 21.6.2013 | Osseor | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 21.6.2013 | Protelos | Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France | Les Laboratoires Servier | 50 rue Carnot, F-92284 Suresnes CEDEX, France |
| Les Laboratoires Servier | | | | |
| 50 rue Carnot, F-92284 Suresnes CEDEX, France | | | | |
| 21.6.2013 | Reyataz | 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 | | | | |
| 21.6.2013 | 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 | | | | |
| 21.6.2013 | Zerit | 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 | | | | |
| 27.6.2013 | Glivec | 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 | | | | |
| 27.6.2013 | Levodopa/Carbidopa/Entacapone Orion | Orion Corporation Orionintie 1, FI-02200 Espoo, Suomi | Orion Corporation | Orionintie 1, FI-02200 Espoo, Suomi |
| Orion Corporation | | | | |
| Orionintie 1, FI-02200 Espoo, Suomi | | | | |
| 27.6.2013 | Rasilamlo | 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 | | | | |
| 27.6.2013 | Rasilez | 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 | | | | |
| 27.6.2013 | Vivanza | Bayer Pharma AG D-13342 Berlin, Deutschland | Bayer Pharma AG | D-13342 Berlin, Deutschland |
| Bayer Pharma AG | | | | |
| D-13342 Berlin, Deutschland | | | | |
| 1.7.2013 | Ariclaim | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 1.7.2013 | Emtriva | 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 | | | | |
| 1.7.2013 | Fampyra | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
| Biogen Idec Limited | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | |
| 1.7.2013 | Intelence | 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 | | | | |
| 1.7.2013 | 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 | | | | |
| 1.7.2013 | Rasilez HCT | 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 | | | | |
| 1.7.2013 | Replagal | Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige | Shire Human Genetic Therapies AB | Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
| Shire Human Genetic Therapies AB | | | | |
| Svärdvägen 11D, SE-182 33 Danderyd, Sverige | | | | |
| 1.7.2013 | Stocrin | 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 | | | | |
| 1.7.2013 | Sustiva | 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 | | | | |
| 1.7.2013 | Trobalt | Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Limited | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Limited | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 1.7.2013 | Truvada | 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 | | | | |
| 1.7.2013 | Viread | 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 | | | | |
| 1.7.2013 | Votrient | Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Limited | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Limited | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 1.7.2013 | Yentreve | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 4.7.2013 | Cymbalta | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 4.7.2013 | Lucentis | 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 | | | | |
| 4.7.2013 | 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 | | | | |
| 4.7.2013 | Xeristar | Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland | Eli Lilly Nederland B.V. | Grootslag 1-5, NL-3991 RA Houten, Nederland |
| Eli Lilly Nederland B.V. | | | | |
| Grootslag 1-5, NL-3991 RA Houten, Nederland | | | | |
| 9.7.2013 | Prevenar 13 | 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 | | | | |
| 9.7.2013 | Tysabri | Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | Biogen Idec Limited | Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
| Biogen Idec Limited | | | | |
| Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | | | | |
| 15.7.2013 | 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 | | | | |
| 15.7.2013 | Onduarp | 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 | | | | |
| 15.7.2013 | Pradaxa | 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 | | | | |
| 15.7.2013 | 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 | | | | |
| 17.7.2013 | Iscover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 17.7.2013 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 17.7.2013 | 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 | | | | |
| 19.7.2013 | Clopidogrel Zentiva | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 19.7.2013 | DuoPlavin | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 19.7.2013 | 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 | | | | |
| 19.7.2013 | Tevagrastim | Teva GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | Teva GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
| Teva GmbH | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | |
| 19.7.2013 | Thalidomide Celgene | 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 | | | | |
| 25.7.2013 | 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 | | | | |
| 25.7.2013 | Biograstim | CT Arzneimittel GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | CT Arzneimittel GmbH | Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
| CT Arzneimittel GmbH | | | | |
| Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | | | | |
| 25.7.2013 | Leflunomide medac | 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 | | | | |
| 25.7.2013 | Remicade | Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland | Janssen Biologics B.V. | Einsteinweg 101, NL-2333 CB Leiden, Nederland |
| Janssen Biologics B.V. | | | | |
| Einsteinweg 101, NL-2333 CB Leiden, Nederland | | | | |
| 25.7.2013 | Tyverb | Glaxo Group Limited 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | Glaxo Group Limited | 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
| Glaxo Group Limited | | | | |
| 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | | | | |
| 25.7.2013 | 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 | | | | |
| 25.7.2013 | Zytiga | 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 | | | | |
| 26.7.2013 | BYDUREON | 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 | | | | |
| 26.7.2013 | DuoCover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 26.7.2013 | Eucreas | 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 | | | | |
| 26.7.2013 | Evicel | Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, B-1831 Diegem, België | Omrix Biopharmaceuticals N.V. | Leonardo Da Vincilaan 15, B-1831 Diegem, België |
| Omrix Biopharmaceuticals N.V. | | | | |
| Leonardo Da Vincilaan 15, B-1831 Diegem, België | | | | |
| 26.7.2013 | Iscover | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 26.7.2013 | Onglyza | 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 | | | | |
| 26.7.2013 | Plavix | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 26.7.2013 | Rasilez | 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 | | | | |
| 26.7.2013 | 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 | | | | |
| 26.7.2013 | Teysuno | Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | Nordic Group B.V. | Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland |
| Nordic Group B.V. | | | | |
| Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland | | | | |
| 31.7.2013 | Aprovel | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 31.7.2013 | CoAprovel | Sanofi Pharma Bristol-Myers Squibb SNC 54 rue La Boétie, F-75008 Paris, France | Sanofi Pharma Bristol-Myers Squibb SNC | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi Pharma Bristol-Myers Squibb SNC | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 31.7.2013 | Copalia | 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 | | | | |
| 31.7.2013 | Copalia HCT | 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 | | | | |
| 31.7.2013 | Dafiro | 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 | | | | |
| 31.7.2013 | Dafiro HCT | 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 | | | | |
| 31.7.2013 | Exforge | 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 | | | | |
| 31.7.2013 | Exforge HCT | 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 | | | | |
| 31.7.2013 | Galvus | 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 | | | | |
| 31.7.2013 | Icandra | 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 | | | | |
| 31.7.2013 | Imprida | 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 | | | | |
| 31.7.2013 | Irbesartan HCT Zentiva | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 31.7.2013 | Irbesartan Zentiva | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 31.7.2013 | Jalra | 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 | | | | |
| 31.7.2013 | Karvea | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 31.7.2013 | Karvezide | Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France | Sanofi-Aventis groupe | 54 rue La Boétie, F-75008 Paris, France |
| Sanofi-Aventis groupe | | | | |
| 54 rue La Boétie, F-75008 Paris, France | | | | |
| 31.7.2013 | Leganto | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 31.7.2013 | Neupro | UCB Manufacturing Ireland Ltd. Shannon Industrial Estate, Co, Clare, Ireland | UCB Manufacturing Ireland Ltd. | Shannon Industrial Estate, Co, Clare, Ireland |
| UCB Manufacturing Ireland Ltd. | | | | |
| Shannon Industrial Estate, Co, Clare, Ireland | | | | |
| 31.7.2013 | ProQuad | Sanofi Pasteur MSD, SNC 8 rue Jonas Salk, F-69007 Lyon, France | Sanofi Pasteur MSD, SNC | 8 rue Jonas Salk, F-69007 Lyon, France |
| Sanofi Pasteur MSD, SNC | | | | |
| 8 rue Jonas Salk, F-69007 Lyon, France | | | | |
| 31.7.2013 | 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 | | | | |
| 31.7.2013 | Vimpat | UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | UCB Pharma S.A. | Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
| UCB Pharma S.A. | | | | |
| Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | | | | |
| 31.7.2013 | Xiliarx | 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 | | | | |
| 31.7.2013 | Zomarist | 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 | | | | |

—   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 |
| -------------------------------------------------------- | ----------------------------- | ------------------------------------------------------------------ | --------------------------------------------- | -------------------------------------------------------- |
| 6.6.2013 | Sepioglin | Vaia S.A. 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα | Vaia S.A. | 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα |
| Vaia S.A. | | | | |
| 1, 28 Octovriou str., Ag. Varvara 123 51, Athens, Ελλάδα | | | | |

—   Lift of suspension of a marketing authorization (Article 20 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 |
| --------------------------------------------- | ----------------------------- | -------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------- |
| 17.7.2013 | Ribavirin Teva | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |
| 17.7.2013 | Ribavirin Teva Pharma BV | Teva Pharma B.V. Computerweg 10, NL-3542 DR Utrecht, Nederland | Teva Pharma B.V. | Computerweg 10, NL-3542 DR Utrecht, Nederland |
| Teva Pharma B.V. | | | | |
| Computerweg 10, NL-3542 DR Utrecht, Nederland | | | | |

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| ---------------------------------------------------------- | ----------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- | --------------------------------------------- | ---------------------------------------------------------- | ----------------------------------------------- | ------------------------ |
| 6.6.2013 | Equilis West Nile | Inactivated chimeric flavivirus strain YF-WN | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/13/151 | Suspension for injection |
| Intervet International B.V. | | | | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | | | | |
| 12.7.2013 | ProZinc | Insulin human | Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | Boehringer Ingelheim Vetmedica GmbH | Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | Suspension for injection |
| Boehringer Ingelheim Vetmedica GmbH | | | | | | | |
| Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | | | | | | | |
| 15.7.2013 | Aftovaxpur Doe | purified, inactivated foot-and-mouth disease virus strains O1 Manisa, O1 BFS, O Taiwan 3/97, A22 Iraq, A24 Cruzeiro, A Turkey 14/98, Asia 1 Shamir | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/153 | Emulsion for injection |
| Merial | | | | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --------------------------------------------------------------- | ----------------------------- | ----------------------------------------------------------------------------------------- | --------------------------------------------- | --------------------------------------------------------------- |
| 6.6.2013 | Equioxx | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 13.6.2013 | Contacera | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 9.7.2013 | Suvaxyn Aujeszky 783 + O/W | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |
| 15.7.2013 | Reconcile | Eli Lilly and Company Ltd Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | Eli Lilly and Company Ltd | Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom |
| Eli Lilly and Company Ltd | | | | |
| Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | | | | |
| 15.7.2013 | Zactran | Merial 29 avenue Tony Garnier, F-69007 Lyon, France | Merial | 29 avenue Tony Garnier, F-69007 Lyon, France |
| Merial | | | | |
| 29 avenue Tony Garnier, F-69007 Lyon, France | | | | |
| 26.7.2013 | Zulvac 1+8 Ovis | Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | Zoetis Belgium S.A. | Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique |
| Zoetis Belgium S.A. | | | | |
| Rue Laid Burniat 1, 1348 Louvain-La-Neuve, Belgique | | | | |

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| ----------------------------------------------------- | ----------------------------- | --------------------------------------------------------------------------------- | --------------------------------------------- | ----------------------------------------------------- |
| 21.6.2013 | Ibaflin | Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | Intervet International B.V. | Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
| Intervet International B.V. | | | | |
| Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | | | | |

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.

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

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