Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-03-16
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012078EN.01000101.xml










16.3.2012   


EN


Official Journal of the European Union


C 78/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2012 to 31 January 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 78/01
—   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




9.1.2012


Efavirenz Teva


efavirenz







Teva Pharma BV




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/11/742/001-010


Film-coated tablet


J05AG03


11.1.2012




13.1.2012


Desloratadine Actavis


desloratadine







Actavis Group PTC ehf.




ReykjavÍkurvegur 76-78,




Hafnarfjörður 220,




Iceland






EU/1/11/745/001-009


Film-coated tablet


R06AX27


17.1.2012




13.1.2012


Desloratadine ratiopharm


desloratadine







ratiopharm GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/11/746/001-012


Film-coated tablet


R06AX27


17.1.2012




31.1.2012


Docetaxel Mylan


Docetaxel







Mylan S.A.S




117 allée des Parcs,




69 800 Saint Priest,




France






EU/1/11/748/001-006


Concentrate for solution for infusion


L01CD02


2.2.2012







—   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




20.1.2012


Luveniq







Lux Biosciences GmbH




MlawGroup,




Maximilianstr. 31,




D-80539 Munich,




Deutschland.






 


24.1.2012







—   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




9.1.2012


Inovelon







Eisai Limited




European Knowledge Centre,




Mosquito Way, Hatfield,




Hertfordshire,




AL10 9SN,




United Kingdom






EU/1/06/378/001-017


11.1.2012




9.1.2012


Leganto







UCB Manufacturing Ireland Ltd.




Shannon Industrial Estate,




Co, Clare,




Ireland






EU/1/11/695/001-055


11.1.2012




9.1.2012


Pumarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/10/664/001


11.1.2012




9.1.2012


Revlimid







Celgene Europe Limited




1 Longwalk Road,




Stockley Park, Uxbridge,




Middlesex,




UB11 1BD,




United Kingdom






EU/1/07/391/001-004


11.1.2012




9.1.2012


Sutent







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/06/347/001-008


11.1.2012




13.1.2012


Diacomit







Biocodex




7 avenue Gallieni,




94250 Gentilly,




France






EU/1/06/367/001-012


17.1.2012




13.1.2012


Erbitux







Merck KGaA




Frankfurter Straße 250,




64271 Darmstadt,




Deutschland






EU/1/04/281/001-005


17.1.2012




13.1.2012


Ilaris







Novartis Europharm Limited




Wimblehurst Road,




Horsham, West Sussex,




RH12 5AB,




United Kingdom






EU/1/09/564/001-003


18.1.2012




13.1.2012


NovoSeven







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/96/006/001-007


17.1.2012




13.1.2012


Olanzapine Mylan







Generics [UK] Limited




Station Close, Potters Bar,




Hertfordshire,




EN6 1TL,




United Kingdom






EU/1/08/475/001-060


18.1.2012




13.1.2012


Revlimid







Celgene Europe Limited




1 Longwalk Road,




Stockley Park, Uxbridge,




Middlesex,




UB11 1BD,




United Kingdom






EU/1/07/391/001-004


18.1.2012




13.1.2012


Stelara







Janssen-Cilag International NV




Turnhoutseweg,




30 - 2340 Beerse –




België






EU/1/08/494/001-004


17.1.2012




13.1.2012


Temodal







Schering Plough Europe




Clos du Lynx 5,




1200 Bruxelles,




Belgique –









Lynx Binnenhof 5,




1200 Brussel,




België






EU/1/98/096/001-025


18.1.2012




13.1.2012


Twinrix Adult







GlaxoSmithKline Biologicals S.A




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/96/020/001-009


17.1.2012




13.1.2012


Twinrix Paediatric







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




B-1330 Rixensart,




Belgique






EU/1/97/029/001-010


17.1.2012




20.1.2012


Champix







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/06/360/001-013


25.1.2012




20.1.2012


ChondroCelect







TiGenix NV




Romeinse straat 12/2,




B-3001 LEUVEN,




België






EU/1/09/563/001


24.1.2012




20.1.2012


Clopidogrel Acino Pharma







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/549/001-007


24.1.2012




20.1.2012


Clopidogrel ratiopharm GmbH







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/541/001-008


24.1.2012




20.1.2012


Glivec







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/01/198/001-013


25.1.2012




20.1.2012


Humira







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead,




Berkshire




SL6 4XE,




United Kingdom






EU/1/03/256/001-010


24.1.2012




20.1.2012


Irbesartan Zentiva







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/06/376/001-033


24.1.2012




20.1.2012


Rebif







Merck Serono Europe Limited




56, Marsh Wall,




London




E14 9TP,




United Kingdom






EU/1/98/063/001-019


25.1.2012




20.1.2012


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park,




Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/06/363/001-015


24.1.2012




20.1.2012


Vectibix







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/07/423/001-003


24.1.2012




20.1.2012


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/382/001-018


25.1.2012




20.1.2012


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/341/001-013


24.1.2012




24.1.2012


Adenuric







Menarini International Operations Luxembourg S.A.




1, Avenue de la Gare,




L-1611 Luxembourg,




Luxembourg






EU/1/08/447/001-012


26.1.2012




24.1.2012


Celvapan







Baxter AG




Industriestraße 67,




A - 1221 Wien,




Österreich






EU/1/08/506/001


26.1.2012




24.1.2012


Cerezyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/97/053/001-005


26.1.2012




24.1.2012


Dynastat







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/209/001-008


26.1.2012




30.1.2012


alli







Glaxo Group Limited




Glaxo Wellcome House,




Berkeley Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/401/007-016


1.2.2012




30.1.2012


Galvus







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






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


1.2.2012




30.1.2012


IDflu







Sanofi Pasteur SA




2, avenue Pont Pasteur,




F-69007 Lyon,




France






EU/1/08/507/001-006


1.2.2012




30.1.2012


Jalra







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/485/001-011


1.2.2012




30.1.2012


Leflunomide medac







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3,




D-20354 Hamburg –




Deutschland






EU/1/10/637/001-009


1.2.2012




30.1.2012


Mimpara







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/04/292/001-012


1.2.2012




30.1.2012


Resolor







Shire-Movetis NV




Veedjik 58,




B-2300 Turnhout,




België






EU/1/09/581/001-008


1.2.2012




30.1.2012


Simulect







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/98/084/001-002


1.2.2012




30.1.2012


Xiliarx







Novartis Europharm Ltd




Wimblehurst Road,




Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/486/001-011


1.2.2012




31.1.2012


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/07/384/001-005


2.2.2012




31.1.2012


InductOs







Medtronic Biopharma BV




Earl Bakkenstraat 10,




6422 PJ Heerlen,




Nederland






EU/1/02/226/001


3.2.2012




31.1.2012


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/09/508/001-011


2.2.2012




31.1.2012


Temodal







Schering Plough Europe




Clos du Lynx 5,




1200 Bruxelles,




Belgique –









Lynx Binnenhof 5,




1200 Brussel,




België






EU/1/98/096/001-025


2.2.2012




31.1.2012


Teysuno







Nordic Group BV




Siriusdreef 22,




2132 WT Hoofddorp,




Nederland






EU/1/11/669/001-004


2.2.2012




31.1.2012


Tyverb







Glaxo Group Limited




Berkeley Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/440/001-006


2.2.2012




31.1.2012


Viread







Gilead Sciences International Limited




Cambridge




CB21 6GT




United Kingdom






EU/1/01/200/001-002


2.2.2012




31.1.2012


Xgeva







Amgen Europe B.V.




Minervum 7061,




4817 ZK Breda,




Nederland






EU/1/11/703/001-003


2.2.2012




31.1.2012


Xyrem







UCB Pharma Ltd.




208 Bath Road, Slough,




Berkshire




SL1 3WE,




United Kingdom






EU/1/05/312/001


2.2.2012




31.1.2012


Yondelis







Pharma Mar, S.A.




Avda. de los Reyes 1,




Polígono Industrial La Mina,




28770 Colmenar Viejo




(Madrid),




Espana






EU/1/07/417/001-002


2.2.2012







—   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




9.1.2012


Activyl Tick Plus


Indoxacarb + permethrin







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/11/137/001-015


Spot-on solution


QP53AC54


11.1.2012







—   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




9.1.2012


Hiprabovis IBR Marker Live







Laboratorios Hipra, S.A.




Avda. La Selva, 135,




17170- Amer (Girona),




España






EU/2/10/114/001-003


11.1.2012




20.1.2012


Posatex







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/08/081/001-003


24.1.2012




24.1.2012


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea,




Co. Galway,




IRELAND






EU/2/07/078/001-017


26.1.2012




31.1.2012


Metacam







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein,




Deutschland






EU/2/97/004/001
EU/2/97/004/003-015
EU/2/97/004/026-040
EU/2/97/004/043-049


2.2.2012




31.1.2012


Procox







Bayer Animal Health GmbH




51368 Leverkusen,




Deutschland






EU/2/11/123/001-002


2.2.2012




31.1.2012


Suvaxyn Aujeszky 783 +O/W







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/98/009/001-006


3.2.2012




31.1.2012


Zubrin







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/00/028/002-008


2.2.2012




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.