Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-03-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012094EN.01000101.xml










30.3.2012   


EN


Official Journal of the European Union


C 94/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2012 to 29 February 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 94/01
—   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




13.2.2012


Colobreathe


Colistimethate sodium







Forest Laboratories UK Ltd




Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford,




Kent




DA2 6SL,




United Kingdom






EU/1/11/747/001


Inhalation powder, hard capsule


R07AX


15.2.2012




17.2.2012


Caprelsa


vandetanib







AstraZeneca AB




Building 411A, Floor 4,




S-151 85 Sodertalje,




Sverige






EU/1/11/749/001-002


Film-coated tablet


L01XE12


21.2.2012




17.2.2012


Vepacel


Prepandemic influenza vaccine (A/H5N1) (whole virion, Vero cell derived, inactivated)







Baxter Innovations GmbH




Industriestrasse 67,




A – 1221 Vienna,




Österreich






EU/1/12/752/001


Suspension for injection


J07BB01


21.2.2012




17.2.2012


Zelboraf


vemurafenib







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/12/751/001


Film-coated tablet


L01XE15


21.2.2012




23.2.2012


Esmya


ulipristal







PregLem France SAS.




32, route de l’Eglise,




74140 Massongy,




France






EU/1/12/750/001


Tablet


Pending


28.2.2012







—   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




9.2.2012


Sumatriptan Galpharm







Galpharm Healthcare Ltd.




Dodworth Business ParkDodworth,




Barnsley




S75 3SP




United Kingdom






 


13.2.2012







—   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




6.2.2012


Aclasta







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/05/308/001-002


9.2.2012




6.2.2012


Aflunov







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/658/001-002


9.2.2012




6.2.2012


Ambirix







GlaxoSmithKline Biologicals S.A.




rue de l’Institut 89,




Rixensart,




B-1330 Belgique






EU/1/02/224/001-005


8.2.2012




6.2.2012


Avastin







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/04/300/001-002


9.2.2012




6.2.2012


Corlentor







Les Laboratoires Servier




50 rue Carnot,




92284 Suresnes, Cedex,




France






EU/1/05/317/001-014


8.2.2012




6.2.2012


Dificlir







FGK Representative Service GmbH




Heimeranstrasse 35,




80339 München,




Deutschland






EU/1/11/733/001-004


9.2.2012




6.2.2012


Erbitux







Merck KGaA




Frankfurter Straße 250,




64271 Darmstadt,




Deutschland






EU/1/04/281/001-005


8.2.2012




6.2.2012


Intanza







Sanofi Pasteur MSD SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/08/505/001-006


8.12.2012




6.2.2012


Olanzapine Apotex







Apotex Europe B.V.




Darwingweg 20,




2333 CR Leiden,




Nederland






EU/1/10/635/001-018


8.2.2012




6.2.2012


Optimark







Covidien Deutschland GmbH




Gewerbepark 1,




93333 Neustadt/Donau,




Deutschland






EU/1/07/398/001-014


8.2.2012




6.2.2012


Orencia







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/07/389/001-003


8.2.2012




6.2.2012


Prialt







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield,




Herts,




AL10 9SN,




United Kingdom






EU/1/04/302/001-004


8.2.2012




6.2.2012


Rapamune







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/01/171/001


9.2.2012




6.2.2012


Remicade







Janssen Biologics B.V.




Einsteinweg 101,




2333 CB Leiden,




Nederland






EU/1/99/116/001-005


8.2.2012




6.2.2012


Rilonacept Regeneron







Regeneron UK Limited




40 Bank Street,




London




E14 5DS,




United Kingdom






EU/1/09/582/001


9.2.2012




6.2.2012


Simponi







Janssen Biologics B.V.




Einsteinweg 101,




2333 CB Leiden,




Nederland






EU/1/09/546/001-004


8.2.2012




6.2.2012


Sonata







Meda AB




Pipers väg 2A,




170 09 Solna,




Sverige






EU/1/99/102/001-006


8.2.2012




6.2.2012


Taxotere







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/95/002/001-005


8.2.2012




6.2.2012


Tevagrastim







Teva GmbH




Graf-Arco-Straße 3,




89079 Ulm,




Deutschland






EU/1/08/445/001-014


8.2.2012




6.2.2012


Votubia







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/710/001-007


9.2.2012




6.2.2012


Yellox







Croma-Pharma GmbH




Industriezeile 6,




A-2100 Leobendorf,




Österreich






EU/1/11/692/001


9.2.2012




9.2.2012


Aerius







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/00/160/001-013
EU/1/00/160/022-034
EU/1/00/160/036-069


13.2.2012




9.2.2012


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


13.2.2012




9.2.2012


Azomyr







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/00/157/001-013
EU/1/00/157/022-067


13.2.2012




9.2.2012


Olazax Disperzi







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b,




140 78 Praha 4,




Česká republika






EU/1/09/592/001-005


13.2.2012




9.2.2012


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-014


13.2.2012




9.2.2012


Prepandemic Influenza







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/657/001-002


13.2.2012




9.2.2012


Prepandemic Influenza







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/657/001-002


13.2.2012




9.2.2012


Procoralan







Les Laboratoires Servier




50, rue Carnot,




92284 Suresnes cedex,




France






EU/1/05/316/001-014


13.2.2012




9.2.2012


Rivastigmine HEXAL







HEXAL AG




Industriestrasse 25,




D-83607 Holzkirchen,




Deutschland






EU/1/09/589/001-018


13.2.2012




13.2.2012


Circadin







RAD Neurim Pharmaceuticals EEC Limited




One Forbury Square, The Forbury, Reading,




Berkshire




RG1 3EB,




United Kingdom






EU/1/07/392/001-003


15.2.2012




13.2.2012


Cystadane







Orphan Europe S.a.r.l.




Immeuble Le Wilson,




70 Avenue du Général de Gaulle,




92800 Puteaux,




France






EU/1/06/379/001


15.2.2012




17.2.2012


Aerinaze







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/399/001-006


21.2.2012




17.2.2012


Elonva







N.V. Organon




Kloosterstraat 6,




5349 AB Oss,




Nederland






EU/1/09/609/001-002


22.2.2012




17.2.2012


Fablyn







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ




United Kingdom






EU/1/08/500/001-004


22.2.2012




17.2.2012


Faslodex







AstraZeneca UK Limited




Alderley Park, Macclesfield,




Cheshire,




SK10 4TG




United Kingdom






EU/1/03/269/001-002


22.2.2012




17.2.2012


Gliolan







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3,




D-20354 Hamburg –




Deutschland






EU/1/07/413/001-003


22.2.2012




17.2.2012


Herceptin







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/00/145/001


21.2.2012




17.2.2012


Isentress







Merck Sharp & Dohme Limited




Hertford Road,




Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/436/001-002


21.2.2012




17.2.2012


Myocet







Cephalon Europe




5 Rue Charles Martigny,




94700 Maisons Alfort,




France






EU/1/00/141/001-002


22.2.2012




17.2.2012


Neoclarityn







Merck Sharp & Dohme Ltd.




Hertford Road,




Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom











EU/1/00/161/001-013




EU/1/00/161/022-067






22.2.2012




17.2.2012


Olanzapine Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/07/427/001-057


21.2.2012




17.2.2012


Olazax







Glenmark Pharmaceuticals s.r.o.




City Tower, Hvězdova 1716/2b,




140 78 Praha 4,




Česká republika






EU/1/09/597/001-005


21.2.2012




17.2.2012


Replagal







Shire Human Genetic Therapies AB




Svärdvägen 11D,




182 33 Danderyd,




Sverige






EU/1/01/189/001-006


22.2.2012




17.2.2012


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Keltenring 1+3,




82041 Oberhaching,




Deutschland






EU/1/09/585/001-018


22.2.2012




17.2.2012


Rivastigmine Sandoz







Sandoz Pharmaceuticals GmbH




Raiffeisenstraße 11,




83607 Holzkirchen,




Deutschland






EU/1/09/599/001-018


21.2.2012




17.2.2012


Tractocile







Ferring Pharmaceuticals A/S




Kay Fiskers Plads 11,




2300 Copenhagen S,




Danmark






EU/1/99/124/001-002


21.2.2012




17.2.2012


Vectibix







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/07/423/001-003


22.2.2012




21.2.2012


Aloxi







Helsinn Birex Pharmaceuticals Ltd




Damastown, Mulhuddart,




Dublin 15,




Republic of Ireland






EU/1/04/306/001-003


23.2.2012




21.2.2012


Angiox







The Medicines Company UK Ltd




115 L Milton Park, Abingdon,




Oxfordshire,




OX14 4SA,




United Kingdom






EU/1/04/289/001


23.2.2012




21.2.2012


Cholestagel







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/03/268/001-004


24.2.2012




21.2.2012


Cubicin







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/05/328/001-004


24.2.2012




21.2.2012


Evra







Janssen-Cilag International NV




Turnhoutseweg, 30 –




2340 Beerse –




België






EU/1/02/223/001-003


24.2.2012




21.2.2012


Fertavid







Merck Sharp & Dohme Ltd.




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/09/510/001-019


24.2.2012




21.2.2012


Glivec







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/01/198/001-013


23.2.2012




21.2.2012


Kaletra







Abbott Laboratories




Abbott House, Vanwall Business Park,




Vanwall Road, Maidenhead,




Berks,




SL6 4XE




United Kingdom






EU/1/01/172/001-008


23.2.2012




21.2.2012


Levitra







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/03/248/001-023


23.2.2012




21.2.2012


Mimpara







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/04/292/001-012


23.2.2012




21.2.2012


PREZISTA







Janssen-Cilag International NV




Turnhoutseweg, 30 –




2340 Beerse –




België






EU/1/06/380/001-005


23.2.2012




21.2.2012


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/05/323/001-013


24.2.2012




21.2.2012


Remicade







Janssen Biologics B.V.




Einsteinweg 101,




2333 CB Leiden,




Nederland






EU/1/99/116/001-005


23.2.2012




21.2.2012


RotaTeq







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/348/001-002


24.2.2012




21.2.2012


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/06/363/001-015


23.2.2012




21.2.2012


Stelara







Janssen-Cilag International NV




Turnhoutseweg, 30 –




2340 Beerse –




België






EU/1/08/494/001-004


24.2.2012




21.2.2012


Vfend







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/212/001-026


23.2.2012




21.2.2012


Victoza







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/09/529/001-005


24.2.2012




21.2.2012


Vimpat







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/




Researchdreef, 60,




1070 Brussel,




België






EU/1/08/470/001-019


23.2.2012




21.2.2012


Visudyne







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/00/140/001


23.2.2012




21.2.2012


Vivanza







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/03/249/001-015


24.2.2012




21.2.2012


Zostavax







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/06/341/001-013


24.2.2012




23.2.2012


Clopidogrel Qualimed







Qualimed




117, Allée des Parcs,




69 800 Saint Priest,




France






EU/1/09/557/001-010


27.2.2012




23.2.2012


Januvia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/383/001-018


27.2.2012




23.2.2012


Resolor







Shire-Movetis NV




Veedjik 58,




B-2300 Turnhout,




België






EU/1/09/581/001-008


27.2.2012




27.2.2012


Bridion







N.V. Organon




Kloosterstraat 6,




5349 AB Oss,




Nederland






EU/1/08/466/001-002


29.2.2012




27.2.2012


Evicel







Omrix Biopharmaceuticals N.V.




Leonardo Da Vinci Laan 15,




B-1831 Diegem,




België






EU/1/08/473/001-003


29.2.2012




27.2.2012


Instanyl







Nycomed Danmark ApS




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/09/531/001-021


29.2.2012




27.2.2012


Irbesartan HCT Zentiva (Ex-Winthrop)







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/06/377/001-028


1.3.2012




27.2.2012


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


29.2.2012




27.2.2012


Olanzapine Glenmark Europe







Glenmark Generics (Europe) Limited




Laxmi House, 2-B Draycott Avenue, Kenton, Harrow,




Middlesex




HA3 OBU,




United Kingdom






EU/1/09/588/001-012


29.2.2012




27.2.2012


Prolia







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/10/618/001-004


29.2.2012




27.2.2012


Twynsta







Boehringer Ingelheim International GmbH




Binger Strasse 173 –




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/10/648/001-028


29.2.2012







—   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




9.2.2012


Clopidogrel Acino Pharma







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/549/001-007


13.2.2012




9.2.2012


Clopidogrel Hexal







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/534/001-007


13.2.2012




13.2.2012


Clopidogrel Acino Pharma GmbH







Acino Pharma GmbH




Am Windfeld 35,




83714 Miesbach,




Deutschland






EU/1/09/548/001-007


15.2.2012







—   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




23.2.2012


RevitaCAM


Meloxicam







Abbott Laboratories Limited




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




Berkshire




SL6 4XE,




UNITED KINGDOM






EU/2/12/138/001-003


Oromucosal spray


QM01AC06


27.2.2012







—   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




17.2.2012


Purevax Rabies







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/117/001-003


21.2.2012




21.2.2012


Dicural







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/97/003/001-018


24.2.2012




27.2.2012


Reconcile







Eli Lilly and Company Ltd




Priestley Road, Basingstoke,




Hampshire,




RG24 9NL,




United Kingdom






EU/2/08/080/001-004


29.2.2012




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.