Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-08-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012264EN.01000101.xml










31.8.2012   


EN


Official Journal of the European Union


C 264/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2012 to 31 July 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 264/01
—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




20.7.2012


Bretaris Genuair


aclidinium bromide







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/12/781/001-003


Inhalation powder


R03BB05


25.7.2012




20.7.2012


Eklira Genuair


aclidinium bromide







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/12/778/001-003


Inhalation powder


R03BB05


25.7.2012




20.7.2012


Jentadueto


linagliptin/metformin hydrochloride







Boehringer Ingelheim International GmbH




Binger Str. 173, D-55216 Ingelheim am Rhein, Deutschland






EU/1/12/780/001-028


Film-coated tablet


A10BD11


25.7.2012




23.7.2012


Fycompa


Perampanel







Eisai Europe Limited




European Knowledge Centre, Mosquito Way, Hatfield, Hertsforshire AL10 9SN, United Kingdom






EU/1/12/776/001-016


Film-coated tablet


N03AX22


25.7.2012




23.7.2012


Kalydeco


ivacaftor







Vertex Pharmaceuticals (U.K.) Limited




88 Milton Park, Abingdon, Oxfordshire OX14 4RY, United Kingdom






EU/1/12/782/001-002


Film-coated tablet


Pending


25.7.2012







—   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




3.7.2012


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/97/030/028-201


5.7.2012




3.7.2012


Kinzalkomb







Bayer Pharma AG




Berlin 13342, Deutschland






EU/1/02/214/001-015


5.7.2012




3.7.2012


MicardisPlus







Boehringer Ingelheim International GmbH




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






EU/1/02/213/001-023


5.7.2012




3.7.2012


Prevenar 13







Wyeth-Lederle Vaccines S.A.




Pleinlaan 17 Boulevard de la Plaine, 1050 Brussel - Bruxelles, Belgïe-Belgique






EU/1/09/590/001-006


5.7.2012




4.7.2012


Arixtra







Glaxo Group Ltd.




Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/02/206/001-035


6.7.2012




4.7.2012


Iasibon







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/10/659/001-010


6.7.2012




4.7.2012


Potactasol







Actavis Group PTC ehf.




Reykjavíkurvegi 76 78, 220 Hafnarfjörður, Iceland






EU/1/10/660/001-002


6.7.2012




6.7.2012


Ganfort







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/06/340/001-002


10.7.2012




6.7.2012


Olazax







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b, 140 78 Praha 4, Česká republika






EU/1/09/597/001-005


10.7.2012




6.7.2012


Simulect







Novartis Europharm Ltd




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






EU/1/98/084/001-002


10.7.2012




6.7.2012


Trizivir







ViiV Healthcare UK Limited




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






EU/1/00/156/002-004


10.7.2012




12.7.2012


Edarbi







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/11/734/001-018


17.7.2012




12.7.2012


Ipreziv







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych, London WC2B 4AE, United Kingdom






EU/1/11/735/001-018


17.7.2012




16.7.2012


Olanzapine Glenmark







Glenmark Generics (Europe) Limited




Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom






EU/1/09/587/001-017


18.7.2012




20.7.2012


Arzerra







Glaxo Group Ltd




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






EU/1/10/625/001
EU/1/10/625/003


24.7.2012




20.7.2012


Avamys







Glaxo Group Ltd




Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/434/001-003


24.7.2012




20.7.2012


BeneFIX







Pfizer Limited




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






EU/1/97/047/004-007


25.7.2012




20.7.2012


Celsentri







ViiV Healthcare UK Ltd




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






EU/1/07/418/001-010


25.7.2012




20.7.2012


Cyanokit







Merck Santé s.a.s.




37, rue Saint-Romain, 69379 Lyon Cedex 08, France






EU/1/07/420/001-002


25.7.2012




20.7.2012


InductOs







Medtronic Biopharma BV




Earl Bakkenstraat 10, 6422 PJ Heerlen, Nederland






EU/1/02/226/001


25.7.2012




20.7.2012


Intelence







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/08/468/001-002


24.7.2012




23.7.2012


Afinitor







Novartis Europharm Ltd




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






EU/1/09/538/001-008


25.7.2012




23.7.2012


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5, 3991 RA Houten, Nederland






EU/1/04/290/001-002


27.7.2012




23.7.2012


Bridion







N.V. Organon




Kloosterstraat 6, 5349 AB Oss, Nederland






EU/1/08/466/001-002


25.7.2012




23.7.2012


Cayston







Gilead Sciences International Limited




Granta Park, Abington, Cambridge CB21 6GT, United Kingdom






EU/1/09/543/001-002


25.7.2012




23.7.2012


Epivir







ViiV Healthcare UK Ltd




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






EU/1/96/015/001-005


27.7.2012




23.7.2012


Eucreas







Novartis Europharm Ltd




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






EU/1/07/425/001-018


25.7.2012




23.7.2012


Galvus







Novartis Europharm Ltd




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






EU/1/07/414/001-010
EU/1/07/414/018


27.7.2012




23.7.2012


Humira







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United Kingdom






EU/1/03/256/001-010


27.7.2012




23.7.2012


Ketek







Aventis Pharma S.A.




20 avenue Raymond Aron, F-92160 Antony, France






EU/1/01/191/001-005


25.7.2012




23.7.2012


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/02/205/001-004


25.7.2012




23.7.2012


Oslif Breezhaler







Novartis Europharm Limited




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






EU/1/09/586/001-010


25.7.2012




26.7.2012


Celvapan







Baxter AG




Industriestraße 67, A-1221 Wien, Österreich






EU/1/08/506/001


30.7.2012




26.7.2012


Esmya







PregLem France SAS.




32, route de l'Eglise, 74140 Massongy, France






EU/1/12/750/001


30.7.2012




26.7.2012


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vinci Laan 15, B-1831 Diegem, België






EU/1/08/473/001-003


30.7.2012




26.7.2012


Grepid







Pharmathen S.A.




6 Dervenakion, 15351 Pallini Attiki, Ελλάδα






EU/1/09/535/001-016


30.7.2012




26.7.2012


Onbrez Breezhaler







Novartis Europharm Ltd




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






EU/1/09/593/001-010


30.7.2012




26.7.2012


Pradaxa







Boehringer Ingelheim International GmbH




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






EU/1/08/442/001-016


30.7.2012




26.7.2012


Silapo







STADA Arzneimittel AG




Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland






EU/1/07/432/001-022


30.7.2012




26.7.2012


Votubia







Novartis Europharm Limited




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






EU/1/11/710/001-007


30.7.2012




26.7.2012


Zalasta







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/07/415/001-056


30.7.2012




31.7.2012


Enbrel







Pfizer Limited




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






EU/1/99/126/001-022


3.8.2012




31.7.2012


Isentress







Merck Sharp & Dohme Limited




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






EU/1/07/436/001-002


3.8.2012




31.7.2012


NovoRapid







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/99/119/001
EU/1/99/119/003
EU/1/99/119/005-015
EU/1/99/119/017-023


3.8.2012




31.7.2012


Tyverb







Glaxo Group Limited




Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom






EU/1/07/440/001-007


2.8.2012




31.7.2012


Victrelis







Merck Sharp & Dohme Limited




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






EU/1/11/704/001-002


3.8.2012







—   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




4.7.2012


Sprimeo







Novartis Europharm Ltd




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






EU/1/07/407/001-040


6.7.2012




6.7.2012


Sprimeo HCT







Novartis Europharm Limited




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






EU/1/11/683/001-080


10.7.2012




16.7.2012


Regranex







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/99/101/001


18.7.2012







—   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 Décision


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




16.7.2012


Nobivac L4


—







Intervet International B.V.




Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland






EU/2/12/143/001-005


Suspension for injection


QI07AB01


18.7.2012




23.7.2012


Cardalis


Benazepril hydrochloride, Spironolactone







CEVA SANTE ANIMALE




10 avenue de la Ballastière, 33500 Libourne, France






EU/2/12/142/001-006


Tablet


QC09BA07


25.7.2012







—   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




4.7.2012


Proteq West Nile







MERIAL




29 avenue Tony Garnier, 69007 LYON, France






EU/2/11/129/001-004


6.7.2012




6.7.2012


Vaxxitek HVT+ IBD







Merial




29 Avenue Tony Garnier, 69007 Lyon, France






EU/2/02/032/001-002


10.7.2012




12.7.2012


Ingelvac CircoFLEX







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/07/079/001-008


17.7.2012




12.7.2012


Novem







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/04/042/001-014


17.7.2012




20.7.2012


ProMeris







Pfizer Limited




Ramsgate Road, Sandwich, Kent CT13 9NJ United Kingdom






EU/2/06/064/001-004


25.7.2012




20.7.2012


ProMeris Duo







Pfizer Limited




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






EU/2/06/065/001-010


25.7.2012




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.