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)
Date: 2013-08-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2013250EN.01003001.xml










30.8.2013   


EN


Official Journal of the European Union


C 250/30





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






EU/1/13/836


Film-coated tablet


N06DX01


17.6.2013




14.6.2013


Votrient


Pazopanib hydrochloride







Glaxo Group Limited




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






EU/1/10/628


Film-coated tablet


L01XE11


18.6.2013




21.6.2013


Capecitabine SUN


Capecitabine







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland






EU/1/13/831


Film-coated tablet


L01BC06


25.6.2013




21.6.2013


Spedra


avanafil







VIVUS B.V.




Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland






EU/1/13/841


Tablet


G04BE


25.6.2013




21.6.2013


Xtandi


enzalutamide







Astellas Pharma Europe B.V.




Sylviusweg 62, NL-2333 BE Leiden, Nederland






EU/1/13/846


Capsule, soft


Pending


25.6.2013




24.6.2013


Nuedexta


Dextromethorphan/quinidine







Jenson Pharmaceutical Services Ltd




Carradine House 237 Regents Park Road, London N3 3LF, United Kingdom






EU/1/13/833


Capsule, hard


N07XX


26.6.2013




24.6.2013


Stayveer


bosentan







Marklas Nederland B.V.




Beneluxlaan 2b, NL-3446 GR Woerden, Nederland






EU/1/13/832


Film-coated tablet


C02KX01


25.6.2013




27.6.2013


MACI


Matrix applied characterised autologous cultured chondrocytes







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/13/847


Implantation matrix


M09AX02


1.7.2013




1.7.2013


Iclusig


ponatinib







ARIAD Pharma Ltd




2 Temple Back East, Temple Quay, Bristol, BS1 6EG, United Kingdom






EU/1/13/839


Film-coated tablet


L01XE24


3.7.2013




1.7.2013


Imatinib Accord


Imatinib







Accord Healthcare Limited




Sage house, 319 Pinner road, North Harrow, Middlesex HA1 4HF, United Kingdom






EU/1/13/845


Film-coated tablet


L01XE01


3.7.2013




12.7.2013


Erivedge


vismodegib







Roche Registration Limited




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






EU/1/13/848


Capsule, hard


L01XX43


17.7.2013




25.7.2013


Lonquex


lipegfilgrastim







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/13/856


Solution for injection


L03AA14


29.7.2013




31.7.2013


Atosiban SUN


atosiban







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland






EU/1/13/852


Concentrate for solution for infusion
Solution for injection


G02CX01


2.8.2013




31.7.2013


Imvanex


modified vaccinia ankara virus







Bavarian Nordic A/S




Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark






EU/1/13/855


Suspension for injection


J07BX


5.8.2013




31.7.2013


Lojuxta


Lomitapide







Aegerion Pharmaceuticals




37/39 avenue Ledru Rollin, F-75012 Paris, France






EU/1/13/851


Capsule, hard


C10AX12


5.8.2013




31.7.2013


PHEBURANE


Sodium Phenylbutyrate







Lucane Pharma




172 rue de Charonne, 75011 Paris, France






EU/1/13/822/


Granules


A16AX03


5.8.2013







—   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






EU/1/11/689


13.6.2013




11.6.2013


Rienso







Takeda Pharma A/S




PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark






EU/1/12/774


13.6.2013




11.6.2013


Zoely







Theramex S.r.l.




Via Messina 38, 20154 Milano, Italia






EU/1/11/690


18.6.2013




13.6.2013


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Estate, Oxford Road, Uxbridge, Middlesex UB8 1LX, United Kingdom.






EU/1/04/276


17.6.2013




13.6.2013


Atripla







Bristol-Myers Squibb and Gilead Sciences Limited




IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland






EU/1/07/430


17.6.2013




13.6.2013


Revlimid







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom






EU/1/07/391


17.6.2013




13.6.2013


Tysabri







Biogen Idec Limited




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






EU/1/06/346


17.6.2013




21.6.2013


Bridion







Organon N.V.




Kloosterstraat 6, NL-5349 AB Oss, Nederland






EU/1/08/466


25.6.2013




21.6.2013


Brinavess







Cardiome UK Limited




Sherborne House, 119-121 Cannon Street, 3rd Floor, London EC4N 5AT, United Kingdom






EU/1/10/645


25.6.2013




21.6.2013


EDURANT







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/736


25.6.2013




21.6.2013


Eviplera







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/11/737


25.6.2013




21.6.2013


Intelence







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/468


25.6.2013




21.6.2013


Javlor







Pierre Fabre Médicament




45, place Abel Gance, F-92100 Boulogne, France






EU/1/09/550


25.6.2013




21.6.2013


Osseor







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/04/287


25.6.2013




21.6.2013


Protelos







Les Laboratoires Servier




50 rue Carnot, F-92284 Suresnes CEDEX, France






EU/1/04/288


25.6.2013




21.6.2013


Reyataz







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/03/267


25.6.2013




21.6.2013


Xenical







Roche Registration Limited




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






EU/1/98/071


25.6.2013




21.6.2013


Zerit







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/96/009


25.6.2013




27.6.2013


Glivec







Novartis Europharm Limited




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






EU/1/01/198


1.7.2013




27.6.2013


Levodopa/Carbidopa/Entacapone Orion







Orion Corporation




Orionintie 1, FI-02200 Espoo, Suomi






EU/1/11/706


1.7.2013




27.6.2013


Rasilamlo







Novartis Europharm Limited




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






EU/1/11/686


1.7.2013




27.6.2013


Rasilez







Novartis Europharm Limited




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






EU/1/07/405


1.7.2013




27.6.2013


Vivanza







Bayer Pharma AG




D-13342 Berlin, Deutschland






EU/1/03/249


1.7.2013




1.7.2013


Ariclaim







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/04/283


3.7.2013




1.7.2013


Emtriva







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/03/261


3.7.2013




1.7.2013


Fampyra







Biogen Idec Limited




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






EU/1/11/699


3.7.2013




1.7.2013


Intelence







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/468


3.7.2013




1.7.2013


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/06/380


3.7.2013




1.7.2013


Rasilez HCT







Novartis Europharm Limited




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






EU/1/08/491


3.7.2013




1.7.2013


Replagal







Shire Human Genetic Therapies AB




Svärdvägen 11D, SE-182 33 Danderyd, Sverige






EU/1/01/189


3.7.2013




1.7.2013


Stocrin







Merck Sharp & Dohme Limited




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






EU/1/99/111


3.7.2013




1.7.2013


Sustiva







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom






EU/1/99/110


3.7.2013




1.7.2013


Trobalt







Glaxo Group Limited




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






EU/1/11/681


3.7.2013




1.7.2013


Truvada







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/04/305


3.7.2013




1.7.2013


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT, United Kingdom






EU/1/01/200


3.7.2013




1.7.2013


Votrient







Glaxo Group Limited




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






EU/1/10/628


3.7.2013




1.7.2013


Yentreve







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/04/280


3.7.2013




4.7.2013


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/04/296


8.7.2013




4.7.2013


Lucentis







Novartis Europharm Limited




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






EU/1/06/374


8.7.2013




4.7.2013


Rasitrio







Novartis Europharm Limited




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






EU/1/11/730


8.7.2013




4.7.2013


Xeristar







Eli Lilly Nederland B.V.




Grootslag 1-5, NL-3991 RA Houten, Nederland






EU/1/04/297


8.7.2013




9.7.2013


Prevenar 13







Pfizer Limited




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






EU/1/09/590


11.7.2013




9.7.2013


Tysabri







Biogen Idec Limited




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






EU/1/06/346


11.7.2013




15.7.2013


Benlysta







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/11/700


17.7.2013




15.7.2013


Onduarp







Boehringer Ingelheim International GmbH




Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/11/729


17.7.2013




15.7.2013


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/08/442


17.7.2013




15.7.2013


Votubia







Novartis Europharm Limited




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






EU/1/11/710


17.7.2013




17.7.2013


Iscover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/98/070


19.7.2013




17.7.2013


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/98/069


19.7.2013




17.7.2013


Votubia







Novartis Europharm Limited




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






EU/1/11/710


19.7.2013




19.7.2013


Clopidogrel Zentiva







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/08/465


23.7.2013




19.7.2013


DuoPlavin







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/10/619


23.7.2013




19.7.2013


Ratiograstim







ratiopharm GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/08/444


23.7.2013




19.7.2013


Tevagrastim







Teva GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/08/445


23.7.2013




19.7.2013


Thalidomide Celgene







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom






EU/1/08/443


23.7.2013




25.7.2013


Aranesp







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/01/185


29.7.2013




25.7.2013


Biograstim







CT Arzneimittel GmbH




Graf-Arco-Straße 3, D-89079 Ulm, Deutschland






EU/1/08/450


29.7.2013




25.7.2013


Leflunomide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstraße 3, D-20354 Hamburg, Deutschland






EU/1/10/637


29.7.2013




25.7.2013


Remicade







Janssen Biologics B.V.




Einsteinweg 101, NL-2333 CB Leiden, Nederland






EU/1/99/116


29.7.2013




25.7.2013


Tyverb







Glaxo Group Limited




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






EU/1/07/440


29.7.2013




25.7.2013


Vectibix







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/07/423


29.7.2013




25.7.2013


Zytiga







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/714


29.7.2013




26.7.2013


BYDUREON







Bristol-Myers Squibb/AstraZeneca EEIG




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






EU/1/11/696


31.7.2013




26.7.2013


DuoCover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/10/623


31.7.2013




26.7.2013


Eucreas







Novartis Europharm Limited




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






EU/1/07/425


30.7.2013




26.7.2013


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vincilaan 15, B-1831 Diegem, België






EU/1/08/473


30.7.2013




26.7.2013


Iscover







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/98/070


31.7.2013




26.7.2013


Onglyza







Bristol-Myers Squibb/AstraZeneca EEIG




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






EU/1/09/545


30.7.2013




26.7.2013


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/98/069


30.7.2013




26.7.2013


Rasilez







Novartis Europharm Limited




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






EU/1/07/405


31.7.2013




26.7.2013


Rasitrio







Novartis Europharm Limited




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






EU/1/11/730


30.7.2013




26.7.2013


Teysuno







Nordic Group B.V.




Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland






EU/1/11/669


31.7.2013




31.7.2013


Aprovel







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/97/046


5.8.2013




31.7.2013


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




54 rue La Boétie, F-75008 Paris, France






EU/1/98/086


5.8.2013




31.7.2013


Copalia







Novartis Europharm Limited




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






EU/1/06/372


2.8.2013




31.7.2013


Copalia HCT







Novartis Europharm Limited




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






EU/1/09/575


5.8.2013




31.7.2013


Dafiro







Novartis Europharm Limited




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






EU/1/06/371


5.8.2013




31.7.2013


Dafiro HCT







Novartis Europharm Limited




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






EU/1/09/574


2.8.2013




31.7.2013


Exforge







Novartis Europharm Limited




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






EU/1/06/370


5.8.2013




31.7.2013


Exforge HCT







Novartis Europharm Limited




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






EU/1/09/569


2.8.2013




31.7.2013


Galvus







Novartis Europharm Limited




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






EU/1/07/414


5.8.2013




31.7.2013


Icandra







Novartis Europharm Limited




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






EU/1/08/484


5.8.2013




31.7.2013


Imprida







Novartis Europharm Limited




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






EU/1/06/373


5.8.2013




31.7.2013


Irbesartan HCT Zentiva







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/06/377


2.8.2013




31.7.2013


Irbesartan Zentiva







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/06/376


5.8.2013




31.7.2013


Jalra







Novartis Europharm Limited




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






EU/1/08/485


5.8.2013




31.7.2013


Karvea







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/97/049


2.8.2013




31.7.2013


Karvezide







Sanofi-Aventis groupe




54 rue La Boétie, F-75008 Paris, France






EU/1/98/085


2.8.2013




31.7.2013


Leganto







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/11/695


2.8.2013




31.7.2013


Neupro







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate, Co, Clare, Ireland






EU/1/05/331


2.8.2013




31.7.2013


ProQuad







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk, F-69007 Lyon, France






EU/1/05/323


2.8.2013




31.7.2013


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/04/274


5.8.2013




31.7.2013


Vimpat







UCB Pharma S.A.




Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België






EU/1/08/470


5.8.2013




31.7.2013


Xiliarx







Novartis Europharm Limited




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






EU/1/08/486


5.8.2013




31.7.2013


Zomarist







Novartis Europharm Limited




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






EU/1/08/483


2.8.2013







—   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






EU/1/12/754


10.6.2013







—   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






EU/1/09/509


19.7.2013




17.7.2013


Ribavirin Teva Pharma BV







Teva Pharma B.V.




Computerweg 10, NL-3542 DR Utrecht, Nederland






EU/1/09/527


19.7.2013







—   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






EU/2/13/151


Suspension for injection


QI05AA10


10.6.2013




12.7.2013


ProZinc


Insulin human







Boehringer Ingelheim Vetmedica GmbH




Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland






EU/2/13/152


Suspension for injection


QA10AC01


16.7.2013




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






EU/2/13/153


Emulsion for injection


QI02AA04


17.7.2013







—   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






EU/2/08/083


11.6.2013




13.6.2013


Contacera







Zoetis Belgium S.A.




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






EU/2/12/144


17.6.2013




9.7.2013


Suvaxyn Aujeszky 783 + O/W







Zoetis Belgium S.A.




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






EU/2/98/009


11.7.2013




15.7.2013


Reconcile







Eli Lilly and Company Ltd




Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom






EU/2/08/080


19.7.2013




15.7.2013


Zactran







Merial




29 avenue Tony Garnier, F-69007 Lyon, France






EU/2/08/082


17.7.2013




26.7.2013


Zulvac 1+8 Ovis







Zoetis Belgium S.A.




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






EU/2/11/120


30.7.2013







—   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






EU/2/00/022


25.6.2013




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






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.