Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-05-25
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012148EN.01000101.xml










25.5.2012   


EN


Official Journal of the European Union


C 148/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 April 2012 to 30 April 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 148/01
—   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




13.4.2012


Bronchitol


Mannitol







Pharmaxis Pharmaceuticals Limited




The Priory, Stomp Road, Burnham,




Buckinghamshire,




SL1 7LW,




United Kingdom






EU/1/12/760/001-002


Inhalation powder, hard capsule


R05CB16


18.4.2012




13.4.2012


Sabervel


Irbesartan







Pharmathen S.A.




6 Dervenakion,




15351 Pallini Attiki,




Ελλάδα






EU/1/12/765/001-006


Film-coated tablet


C09CA04


17.4.2012




20.4.2012


Capecitabine Accord


capecitabine







Accord Healthcare Limited




Sage house, 319 Pinner road, North Harrow,




Middlesex




HA1 4HF




United Kingdom






EU/1/12/762/001-018


Film-coated tablet


L01BC06


25.4.2012




20.4.2012


Capecitabine Krka


capecitabine







KRKA, d.d




Novo mesto, Šmarješka cesta 6,




8501 Novo mesto,




Slovenia






EU/1/12/763/001-018


Film-coated tablet


L01BC06


25.4.2012




20.4.2012


Capecitabine Teva


capecitabine







TEVA Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/12/761/001-002


Film-coated tablet


L01BC06


25.4.2012




20.4.2012


Nimenrix


Meningococcal group A, C, W-135 and Y conjugate vaccine







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/12/767/001-007


Powder and solvent for solution for injection


J07AH08


25.4.2012




20.4.2012


SANCUSO


granisetron







ProStrakan Limited




Galabank Business Park,




Galashiels,




TD1 1QH,




United Kingdom






EU/1/12/766/001


Transdermal patch


A04AA02


25.4.2012




20.4.2012


Zoledronic acid Actavis


zoledronic acid







Actavis Group PTC ehf.




ReykjavÍkurvegur 76-78,




Hafnarfjörður 220,




Iceland






EU/1/12/759/001-003


Concentrate for solution for infusion


M05BA08


26.4.2012




24.4.2012


Signifor


pasireotide







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/12/753/001-012


Solution for injection


H01CB05


27.4.2012







—   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




3.4.2012


Kinzalkomb







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/02/214/001-015


5.4.2012




4.4.2012


Humira







Abbott Laboratories Ltd




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




Berkshire




SL6 4XE,




United Kingdom






EU/1/03/256/001-010


10.4.2012




4.4.2012


Plavix







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris,




France






EU/1/98/069/001a-001b
EU/1/98/069/002a-002b
EU/1/98/069/003a-003b
EU/1/98/069/004a-004b
EU/1/98/069/005a-005b
EU/1/98/069/006a-006b
EU/1/98/069/007a-007b
EU/1/98/069/008-010
EU/1/98/069/011a-011b
EU/1/98/069/012


11.4.2012




4.4.2012


Rebetol







Schering Plough Europe




Clos du Lynx 5,




1200 Bruxelles,




Belgique –









Lynx Binnenhof 5,




1200 Brussel,




België






EU/1/99/107/001-005


11.4.2012




4.4.2012


Telzir







ViiV Healthcare UK Ltd




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






EU/1/04/282/001-002


11.4.2012




10.4.2012


Vedrop







Orphan Europe SARL




Immeuble Le Wilson -




70 Avenue du Général de Gaulle -




F 92 800 Puteaux -




France






EU/1/09/533/001-003


12.4.2012




13.4.2012


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19,




NL-2353 EW Leiderdorp,




Nederland






EU/1/07/387/001-026


17.4.2012




13.4.2012


alli







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/401/007-016


17.4.2012




13.4.2012


Champix







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/06/360/001-013


17.4.2012




13.4.2012


Evoltra







Genzyme Europe BV




Gooimeer 10,




1411 DD Naarden,




Nederland






EU/1/06/334/001-005


17.4.2012




13.4.2012


Foscan







Biolitec pharma Ltd




United Drug House, Magna Drive,




Dublin 24,




Ireland






EU/1/01/197/003-005


17.4.2012




13.4.2012


Pradaxa







Boehringer Ingelheim International GmbH




Binger Strasse 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442/001-014


17.4.2012




13.4.2012


Prometax







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/98/092/001-026


17.4.2012




13.4.2012


Revatio







Pfizer Limited




Sandwich,




Kent,




CT13 9NJ,




United Kingdom






EU/1/05/318/001


17.4.2012




13.4.2012


Revlimid







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge,




Middlesex,




UB11 1DB,




United Kingdom






EU/1/07/391/001-004


17.4.2012




13.4.2012


Soliris







Alexion Europe S.A.S.




25, boulevard de l'Amiral Bruix,




75016 Paris,




France






EU/1/07/393/001


17.4.2012




13.4.2012


Tyverb







Glaxo Group Limited




Berkeley Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/440/001-006


17.4.2012




13.4.2012


Viramune







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/97/055/001-009


17.4.2012




13.4.2012


Volibris







Glaxo Group Ltd




Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/08/451/001-004


17.4.2012




20.4.2012


Abraxane







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge,




Middlesex,




UB11 1DB,




United Kingdom






EU/1/07/428/001


24.4.2012




20.4.2012


Aclasta







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/05/308/001-002


25.4.2012




20.4.2012


Aflunov







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/658/001-002


26.4.2012




20.4.2012


Altargo







Glaxo Group Limited




Glaxo Wellcome House, Berkeley Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/07/390/001-004


26.4.2012




20.4.2012


Apidra







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/04/285/001-036


26.4.2012




20.4.2012


Ceplene







EpiCept GmbH




Goethestrasse 4,




D-80336 München,




Deutschland






EU/1/08/477/001


24.4.2012




20.4.2012


Circadin







RAD Neurim Pharmaceuticals EEC Limited




One Forbury Square, The Forbury, Reading,




Berkshire




RG1 3EB,




United Kingdom






EU/1/07/392/001-003


25.4.2012




20.4.2012


Exelon







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/98/066/001-026


26.3.2012




20.4.2012


Focetria







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/07/385/001-002
EU/1/07/385/004


26.4.2012




20.4.2012


HALAVEN







Eisai Europe Limited




European Knowledge Centre, Mosquito Way, Hatfield,




Herts




AL10 9SN,




United Kingdom






EU/1/11/678/001-002


25.4.2012




20.4.2012


Helixate NexGen







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/00/144/001-005


25.4.2012




20.4.2012


Humira







Abbott Laboratories Ltd




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




Berkshire




SL6 4XE,




United Kingdom






EU/1/03/256/002-010


25.4.2012




20.4.2012


Insulin Human Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/06/368/001-015
EU/1/06/368/020-024
EU/1/06/368/029-033
EU/1/06/368/037-042
EU/1/06/368/047-051
EU/1/06/368/056-057
EU/1/06/368/088-102
EU/1/06/368/113-150
EU/1/06/368/163-168


25.4.2012




20.4.2012


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/97/030/028-195


26.4.2012




20.4.2012


IOA







N.V. Organon




Kloosterstraat 6,




5349 AB Oss,




Nederland






EU/1/11/689/001-002


24.4.2012




20.4.2012


Iressa







AstraZeneca AB




S 151 85 Sodertalje,




Sverige






EU/1/09/526/001-002


26.4.2012




20.4.2012


Kogenate Bayer







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/00/143/004-013


25.4.2012




20.4.2012


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/00/134/001-037


25.4.2012




20.4.2012


Norvir







Abbott Laboratories Ltd




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




Berkshire




SL6 4XE,




United Kingdom






EU/1/96/016/001
EU/1/96/016/003-008


26.4.2012




20.4.2012


NovoNorm







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/98/076/004-006
EU/1/98/076/011-013
EU/1/98/076/018-020
EU/1/98/076/022-024


26.3.2012




20.4.2012


Opgenra







Olympus Biotech International Limited




Raheen Business Park, Limerick,




Ireland






EU/1/08/489/001-002


24.4.2012




20.4.2012


Optimark







Covidien Deutschland GmbH




Gewerbepark 1,




93333 Neustadt/Donau,




Deutschland






EU/1/07/398/001-014


26.3.2012




20.4.2012


Optisulin







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/00/133/001-032


25.4.2012




20.4.2012


Pelzont







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/08/460/001-014


25.4.2012




20.4.2012


Prandin







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/00/162/003-005
EU/1/00/162/009-011
EU/1/00/162/015-017
EU/1/00/162/019-021


26.4.2012




20.4.2012


Preotact







Nycomed Danmark ApS




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/06/339/001-003


25.4.2012




20.4.2012


Prolia







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/10/618/001-004


24.4.2012




20.4.2012


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/05/323/001-013


26.4.2012




20.4.2012


Rasilamlo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/686/001-056


24.4.2012




20.4.2012


Rasilez







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/405/001-040


24.4.2012




20.4.2012


Riprazo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/409/001-040


24.4.2012




20.4.2012


Riprazo HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/680/001-080


24.4.2012




20.4.2012


Samsca







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park, Oxford Road, Uxbridge,




Middlesex




UB8 1LX,




United Kingdom






EU/1/09/539/001-004


24.4.2012




20.4.2012


Sebivo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/388/001-003


26.4.2012




20.4.2012


Silodyx







Recordati Ireland Ltd.




Raheens East, Ringaskiddy Co. Cork,




Ireland






EU/1/09/607/001-014


24.4.2012




20.4.2012


Sprimeo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/407/001-040


24.4.2012




20.4.2012


Sprimeo HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/683/001-080


24.4.2012




20.4.2012


Tracleer







Actelion Registration Ltd




BSI Building 13th Floor, 389 Chiswick High Road,




London




W4 4AL,




United Kingdom






EU/1/02/220/001-006


26.4.2012




20.4.2012


Tredaptive







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/08/459/001-014


25.4.2012




20.4.2012


Trevaclyn







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/08/458/001-014


25.4.2012




20.4.2012


Urorec







Recordati Ireland Ltd.




Raheens East, Ringaskiddy Co. Cork,




Ireland






EU/1/09/608/001-014


24.4.2012




20.4.2012


Ventavis







Bayer Pharma AG




13342 Berlin,




Deutschland






EU/1/03/255/001-008


26.4.2012




20.4.2012


Vfend







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/1/02/212/001-026


25.4.2012




20.4.2012


Victoza







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/09/529/001-005


24.4.2012




20.4.2012


Vidaza







Celgene Europe Ltd




1 Longwalk Road, Stockley Park,




Uxbridge,




UB11 1DB,




United Kingdom






EU/1/08/488/001


24.4.2012




20.4.2012


Xenical







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn




Garden City,




AL7 1TW,




United Kingdom






EU/1/98/071/001-006


24.4.2012




20.4.2012


Yttriga







Eckert & Ziegler Radiopharma GmbH




Robert-Rössle-Str. 10,




13125 Berlin,




Deutschland






EU/1/05/322/001-002


26.4.2012




20.4.2012


Zoely







Theramex S.r.l.




Via Messina 38,




20154 Milano,




Italia






EU/1/11/690/001-002


24.4.2012




24.4.2012


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/614/001-003


27.4.2012




24.4.2012


Rasilez HCT







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/491/001-080


27.4.2012




24.4.2012


Temomedac







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3,




D-20354 Hamburg -




Deutschland






EU/1/09/605/001-012


27.4.2012




26.4.2012


Revolade







GlaxoSmithKline Trading Services Limited




6900 Cork Airport Business Park, Kinsale Road, Cork,




Ireland






EU/1/10/612/001-006


30.4.2012




26.4.2012


Yervoy







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/11/698/001-002


30.4.2012







—   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




20.4.2012


PhotoBarr







Pinnacle Biologics B.V.




p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10,




1043 DP Amsterdam,




Nederland






EU/1/04/272/001-002


25.4.2012




24.4.2012


Refludan







Celgene Europe Ltd




1 Longwalk Road, Stockley Park,




Uxbridge,




UB11 1DB,




United Kingdom






EU/1/97/035/001-004


27.4.2012







—   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




10.4.2012


Slentrol







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/2/07/071/001-003


12.4.2012




13.4.2012


Cerenia







Pfizer Ltd




Ramsgate Road, Sandwich,




Kent




CT 13 9NJ,




United Kingdom






EU/2/06/062/005


17.4.2012




20.4.2012


BTVPUR AlSap 1







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/112/001-005


25.4.2012




20.4.2012


BTVPUR AlSap 1-8







MERIAL




29 avenue Tony Garnier,




69007 LYON,




France






EU/2/10/113/001-005


25.4.2012




20.4.2012


Loxicom







Norbrook Laboratories Limited




Station Works, Newry,




Co. Down,




BT35 6JP,




United Kindgom






EU/2/08/090/001-027


24.4.2012




20.4.2012


Meloxivet







Janssen Pharmaceutica N.V.




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/2/07/077/001-005


25.4.2012




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.