Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 2012 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2012-12-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012401EN.01000301.xml










28.12.2012   


EN


Official Journal of the European Union


C 401/3





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2012 to 30 November 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 401/02
—   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




12.11.2012


Forxiga


dapagliflozin







Bristol Myers Squibb/AstraZeneca EEIG




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






EU/1/12/795


Film-coated tablet


A10BX09


14.11.2012




15.11.2012


Picato


ingenol mebutate







LEO Pharma A/S




Industriparken 55, DK-2750 Ballerup, Danmark






EU/1/12/796


Gel


D06BX02


19.11.2012




19.11.2012


Capecitabine medac


capecitabine







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3, D-20354 Hamburg - Deutschland






EU/1/12/802


Film-coated tablet


L01BC06


23.11.2012




19.11.2012


Ibandronic acid Accord


Ibandronic acid







Accord Healthcare Limited




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






EU/1/12/798


Concentrate for solution for infusion


M05BA06


23.11.2012




19.11.2012


Zoledronic acid Hospira


zoledronic acid







Hospira UK Ltd.




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/12/800


Concentrate for solution for infusion
Solution for infusion


M05BA


23.11.2012




22.11.2012


Eylea


aflibercept







Bayer Pharma AG




D - 13342 Berlin, Deutschland






EU/1/12/797


Solution for injection


S01LA05


26.11.2012




22.11.2012


Memantine Merz


Memantine







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100, D-60318 Frankfurt/Main - Deutschland






EU/1/12/799


Film-coated tablet
Oral solution


N06DX01


26.11.2012




26.11.2012


Constella


linaclotide







Almirall, S.A.




Ronda General Mitre, 151, 08022 Barcelona, España






EU/1/12/801


Capsule, hard


Pending


28.11.2012







—   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




8.11.2012


Enyglid







KRKA, d. d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/09/580


12.11.2012




8.11.2012


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Keltenring 1 + 3, Oberhaching 82041, Deutschland






EU/1/09/585


12.11.2012




12.11.2012


Ivemend







Merck Sharp & Dohme Limited




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






EU/1/07/437


14.11.2012




12.11.2012


Olanzapine Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/427


14.11.2012




15.11.2012


Naglazyme







BioMarin Europe Ltd




164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom






EU/1/05/324


19.11.2012




15.11.2012


Prolia







Amgen Europe B.V.




Minervum 7061, NL-4817 ZK Breda, Nederland






EU/1/10/618


19.11.2012




15.11.2012


Retacrit







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom






EU/1/07/431


19.11.2012




15.11.2012


Sutent







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/06/347


19.11.2012




15.11.2012


Xaluprine







Nova Laboratories Limited




Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom






EU/1/11/727


19.11.2012




15.11.2012


Xarelto







Bayer Pharma AG




13342 Berlin, Deutschland






EU/1/08/472


19.11.2012




19.11.2012


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House, Highbridge Business Park, Oxford Road, Uxbridge, Middlesex UB8 1HU, United Kingdom






EU/1/04/276


22.11.2012




19.11.2012


Actraphane







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1, 53100 Siena, Italia






EU/1/02/229


22.11.2012




19.11.2012


Actrapid







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/230


22.11.2012




19.11.2012


Apidra







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main, Deutschland






EU/1/04/285


23.11.2012




19.11.2012


Champix







Pfizer Ltd




Ramsgate Road, Sandwich, Kent CT 13 9NJ, United Kingdom






EU/1/06/360


22.11.2012




19.11.2012


Eliquis







Bristol-Myers Squibb/Pfizer EEIG




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






EU/1/11/691


23.11.2012




19.11.2012


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30, B-2340 Beerse, België






EU/1/11/720


22.11.2012




19.11.2012


Insulatard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/233


22.11.2012




19.11.2012


Ketek







Aventis Pharma S.A.




20 avenue Raymond Aron, F-92160 Antony, France






EU/1/01/191


22.11.2012




19.11.2012


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, Co. Mayo, Ireland






EU/1/02/205


23.11.2012




19.11.2012


Mirapexin







Boehringer Ingelheim International GmbH




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






EU/1/97/051


23.11.2012




19.11.2012


Mixtard







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/231


22.11.2012




19.11.2012


Mycophenolate mofetil Teva







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/439


22.11.2012




19.11.2012


Myfenax







Teva Pharma B.V.




Computerweg 10, DR Utrecht 3542, Nederland






EU/1/07/438


22.11.2012




19.11.2012


Protaphane







Novo Nordisk A/S




Novo Allé, DK-2880 Bagsvaerd, Danmark






EU/1/02/234


22.11.2012




19.11.2012


Revlimid







Celgene Europe Limited




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






EU/1/07/391


22.11.2012




19.11.2012


Sifrol







Boehringer Ingelheim International GmbH




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






EU/1/97/050


22.11.2012




19.11.2012


Simponi







Janssen Biologics B.V.




Einsteinweg 101, CB Leiden 2333, Nederland






EU/1/09/546


23.11.2012




19.11.2012


Sprycel







Bristol-Myers Squibb Pharma EEIG




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






EU/1/06/363


22.11.2012




19.11.2012


Tysabri







Elan Pharma International Ltd.




Treasury Building, Lower Grand Canal Street, Dublin 2, IRELAND






EU/1/06/346


23.11.2012




22.11.2012


Diacomit







Biocodex




7 avenue Gallieni, 94250 Gentilly, France






EU/1/06/367


26.11.2012




22.11.2012


GILENYA







Novartis Europharm Ltd




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






EU/1/11/677


26.11.2012




22.11.2012


Humira







AbbVie Ltd.




Maidenhead, SL6 4XE, United Kingdom






EU/1/03/256


26.11.2012




22.11.2012


Olanzapine Apotex







Apotex Europe B.V.




Darwinweg 20, 2333 CR Leiden, Nederland






EU/1/10/635


26.11.2012




22.11.2012


Prevenar 13







Pfizer Limited




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






EU/1/09/590


27.11.2012




22.11.2012


Rasilez







Novartis Europharm Ltd




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






EU/1/07/405


26.11.2012




22.11.2012


Rasilez HCT







Novartis Europharm Ltd




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






EU/1/08/491


26.11.2012




22.11.2012


Rasitrio







Novartis Europharm Limited




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






EU/1/11/730


26.11.2012




22.11.2012


Remicade







Janssen Biologics B.V.




Einsteinweg 101, 2333 CB Leiden, Nederland






EU/1/99/116


27.11.2012




22.11.2012


Riprazo







Novartis Europharm Ltd




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






EU/1/07/409


26.11.2012




22.11.2012


Rivastigmine HEXAL







HEXAL AG




Industriestrasse 25, D-83607 Holzkirchen, Deutschland






EU/1/09/589


27.11.2012




22.11.2012


RoActemra







Roche Registration Limited




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






EU/1/08/492


27.11.2012




22.11.2012


Thyrogen







Genzyme Europe B.V.




Gooimeer 10, NL-1411 DD Naarden, Nederland






EU/1/99/122


27.11.2012




22.11.2012


Tracleer







Actelion Registration Ltd




Chiswick Tower 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom






EU/1/02/220


27.11.2012




22.11.2012


Vimpat







UCB Pharma SA.




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






EU/1/08/470


27.11.2012




22.11.2012


Viread







Gilead Sciences International Limited




Cambridge CB21 6GT United Kingdom






EU/1/01/200


27.11.2012




26.11.2012


Temodal







Merck Sharp & Dohme Limited




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






EU/1/98/096


28.11.2012




30.11.2012


Gardasil







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk, 69007 Lyon, France






EU/1/06/357


30.11.2012




30.11.2012


Olazax







Glenmark Pharmaceuticals s.r.o.




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






EU/1/09/597


4.12.2012




30.11.2012


Silgard







Merck Sharp & Dohme Ltd




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






EU/1/06/358


4.12.2012




30.11.2012


Tygacil







Pfizer Limited




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






EU/1/06/336


4.12.2012




30.11.2012


Zevalin







Spectrum Pharmaceuticals B.V.




Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland






EU/1/03/264


4.12.2012







—   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




8.11.2012


Inflacam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, IRELAND






EU/2/11/134


12.11.2012




8.11.2012


Meloxivet







Eli Lilly and Company Limited




Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom






EU/2/07/077


12.11.2012




12.11.2012


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea, Co. Galway, IRELAND






EU/2/07/078


14.11.2012




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.