Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-07-31
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009178EN.01001501.xml










31.7.2009   


EN


Official Journal of the European Union


C 178/15





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (1)
)

2009/C 178/12
—   Issuing of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code
(Anatomical Therapeutic Chemical Code)


Date of notification




10.6.2009


Renvela


Sevelamer (carbonate)







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/09/521/001-003
EU/1/09/521/004-007


Film-coated tablet
Powder for oral suspension


V03AE02


12.6.2009




12.6.2009


PANTOLOC Control


Pantoprazole







Nycomed GmbH




Byk-Gulden-Str. 2




78467 Konstanz




DEUTSCHLAND






EU/1/09/519/001-004


Gastro-resistant tablet


A02BC02


16.6.2009




12.6.2009


PANTOZOL Control


Pantoprazole







Nycomed GmbH




Byk-Gulden-Str. 2




78467 Konstanz




DEUTSCHLAND






EU/1/09/517/001-004


Gastro-resistant tablet


A02BC02


16.6.2009




12.6.2009


PANTECTA Control


Pantoprazole







Nycomed GmbH




Byk-Gulden-Str. 2




78467 Konstanz




DEUTSCHLAND






EU/1/09/518/001-004


Gastro-resistant tablet


A02BC02


16.6.2009




12.6.2009


CONTROLOC Control


Pantoprazole







Nycomed GmbH




Byk-Gulden-Str. 2




78467 Konstanz




DEUTSCHLAND






EU/1/09/515/001-004


Gastro-resistant tablet


A02BC02


16.6.2009




12.6.2009


SOMAC Control


Pantoprazole







Nycomed GmbH




Byk-Gulden-Str. 2




78467 Konstanz




DEUTSCHLAND






EU/1/09/516/001-004


Gastro-resistant tablet


A02BC02


16.6.2009




24.6.2009


IRESSA


Gefitinib







AstraZeneca AB




SE-151 85 Sodertalje




SVERIGE






EU/1/09/526/001


Film-coated tablet


L01XE02


26.6.2009




29.6.2009


Repaglinide Teva


Repaglinide







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




NEDERLAND






EU/1/09/530/001-015


Tablet


A10BX02


1.7.2009




30.6.2009


Victoza


Liraglutide







Novo Nordisk A/S




Novo Allé




2880 Bagsvaerd




DANMARK






EU/1/09/529/001-005


Solution for injection in pre-filled pen


A10BX07


2.7.2009




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




2.6.2009


Avamys







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/07/434/001-003


5.6.2009




2.6.2009


Alisade







Glaxo Group Ltd




Greenford




Middlesex




UB6 ONN




UNITED KINGDOM






EU/1/08/474/001-003


5.6.2009




2.6.2009


Ketek







Aventis Pharma S.A.




20 avenue Raymond Aron




92160 Antony




FRANCE






EU/1/01/191/001-005


5.6.2009




2.6.2009


Stocrin







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/99/111/001-005
EU/1/99/111/008-011


5.6.2009




2.6.2009


Velmetia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/456/001-016


5.6.2009




2.6.2009


Ferriprox







Apotex Europe B.V.




Darwingweg 20




2333 CR Leiden




NEDERLAND






EU/1/99/108/001-003


4.6.2009




2.6.2009


Januvia







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/07/383/001-018


5.6.2009




2.6.2009


Janumet







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/455/001-016


5.6.2009




2.6.2009


Silgard







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/06/358/001-021


4.6.2009




2.6.2009


Sustiva







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/99/110/001-005
EU/1/99/110/008-010


5.6.2009




2.6.2009


Efficib







Merck Sharp & Dohme Ltd




Hertford Road




Hoddesdon




Hertfordshire




EN11 9BU




UNITED KINGDOM






EU/1/08/457/001-016


5.6.2009




4.6.2009


Avandamet







SmithKline Beecham plc




980 Great West Road




Brentford




Middlesex




TW8 9GS




UNITED KINGDOM






EU/1/03/258/001-022


8.6.2009




4.6.2009


Ovitrelle







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/00/165/001-007


8.6.2009




8.6.2009


Tasigna







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/07/422/001-004


10.6.2009




8.6.2009


Ziagen







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/99/112/001-002


10.6.2009




8.6.2009


Pergoveris







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/07/396/001-003


10.6.2009




8.6.2009


Baraclude







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/06/343/001-007


10.6.2009




8.6.2009


REYATAZ







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park




Sanderson Road




Uxbridge




UB8 1DH




UNITED KINGDOM






EU/1/03/267/001-010


10.6.2009




8.6.2009


Abilify







Otsuka Pharmaceutical Europe Ltd




Hunton House




Highbridge Business Park




Oxford Road




Uxbridge




Middlesex




UB8 1HU




UNITED KINGDOM






EU/1/04/276/001-020
EU/1/04/276/024-036


10.6.2009




8.6.2009


Kivexa







Glaxo Group Ltd




Greenford




Middlesex




UB6 0NN




UNITED KINGDOM






EU/1/04/298/001-003


10.6.2009




9.6.2009


GONAL-f







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/95/001/001
EU/1/95/001/003-005
EU/1/95/001/009
EU/1/95/001/012
EU/1/95/001/021-022
EU/1/95/001/025-028
EU/1/95/001/031-035


11.6.2009




17.6.2009


Erbitux







Merck KGaA




Frankfurter Straße 250




64271 Darmstadt




DEUTSCHLAND






EU/1/04/281/001-005


19.6.2009




17.6.2009


Lucentis







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/06/374/001


19.6.2009




18.6.2009


Vivanza







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND









Bayer AG




51368 Leverkusen




DEUTSCHLAND






EU/1/03/249/001-012


22.6.2009




18.6.2009


Vasovist







TMC Pharma Services Ltd




Eversley




Hampshire




RG27 0NT




UNITED KINGDOM









Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND






EU/1/05/313/001-009


22.6.2009




18.6.2009


Angiox







The Medicines Company UK Ltd




115 L Milton Park




Abingdon




Oxfordshire




OX14 4SA




UNITED KINGDOM






EU/1/04/289/001-002


22.6.2009




18.6.2009


Emtriva







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/03/261/001-002


22.6.2009




22.6.2009


Aclasta







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






EU/1/05/308/001-002


24.6.2009




22.6.2009


Yondelis







Pharma Mar, S.A.




Avda. de los Reyes 1




Polígono Industrial La Mina




28770 Colmenar Viejo Madrid




ESPAÑA






EU/1/07/417/001-002


24.6.2009




22.6.2009


Levitra







Bayer Schering Pharma AG




13342 Berlin




DEUTSCHLAND









Bayer AG




51368 Leverkusen




DEUTSCHLAND






EU/1/03/248/001-012


25.6.2009




23.6.2009


Ebixa







H. Lundbeck A/S




Ottiliavej 9




2500 Valby




DANMARK






EU/1/02/219/001-049


25.6.2009




23.6.2009


Prezista







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/06/380/004-005


25.6.2009




23.6.2009


Prezista







Janssen-Cilag International NV




Turnhoutseweg 30




2340 Beerse




BELGIË






EU/1/06/380/001-002


25.6.2009




23.6.2009


Yondelis







Pharma Mar, S.A.




Avda. de los Reyes, 1




Polígono Industrial La Mina




28770 Colmenar Viejo Madrid




ESPAÑA






EU/1/07/417/001-002


25.6.2009




23.6.2009


Aptivus







Boehringer Ingelheim International GmbH




Binger Straße 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/05/315/002


25.6.2009




23.6.2009


Aptivus







Boehringer Ingelheim International GmbH




Binger Straße 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/05/315/001


25.6.2009




24.6.2009


Ariclaim







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/283/008-012


26.6.2009




24.6.2009


YENTREVE







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/280/001-008


26.6.2009




24.6.2009


Xeristar







Boehringer Ingelheim International GmbH




Binger Straße 173




55216 Ingelheim am Rhein




DEUTSCHLAND






EU/1/04/297/001-008


29.6.2009




24.6.2009


Neupro







Schwarz Pharma Ltd




Shannon




Industrial Estate




Co. Clare




IRELAND






EU/1/05/331/001-055


26.6.2009




24.6.2009


Cymbalta







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/296/001-009


26.6.2009




24.6.2009


Axura







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100-104




60318 Frankfurt/Main




DEUTSCHLAND






EU/1/02/218/001-029


26.6.2009




29.6.2009


RotaTeq







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk




69007 Lyon




FRANCE






EU/1/06/348/001-002


2.7.2009




29.6.2009


Yttriga







Nuclitec GmbH




Gieselweg 1




38110 Braunschweig




DEUTSCHLAND






EU/1/05/322/001


1.7.2009




29.6.2009


Kepivance







Biovitrum AB (publ)




SE-112 76 Stockholm




SVERIGE






EU/1/05/314/001


2.7.2009




29.6.2009


Effentora







Cephalon Europe




5 rue Charles Martigny




94700 Maisons-Alfort




FRANCE






EU/1/08/441/001-010


1.7.2009




30.6.2009


Cerezyme







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






EU/1/97/053/001-005


2.7.2009




30.6.2009


Hepsera







Gilead Sciences International Limited




Cambridge




CB21 6GT




UNITED KINGDOM






EU/1/03/251/001-002


2.7.2009




30.6.2009


Kineret







Biovitrum AB (publ)




SE-112 76 Stockholm




SVERIGE






EU/1/02/203/001-004


2.7.2009




30.6.2009


Ariclaim







Eli Lilly Nederland B.V.




Grootslag 1-5




3991 RA Houten




NEDERLAND






EU/1/04/283/008-012


2.7.2009




30.6.2009


BeneFIX







Wyeth Europa Ltd




Huntercombe Lane South




Taplow




Maidenhead




Berkshire




SL6 0PH




UNITED KINGDOM






EU/1/97/047/001-007


2.7.2009




—   Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




9.6.2009


Raptiva







Serono Europe Limited




56 Marsh Wall




London




E14 9TP




UNITED KINGDOM






EU/1/04/291/001-003


11.6.2009




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
 (2)
): Accepted













Date of the decision


Name of the medicinal product


INN
(International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code
(Anatomical Therapeutic Chemical Code)


Date of notification




17.6.2009


Leucogen


 







Virbac




1ère avenue




2065 m L.I.D.




06516 Carros Cedex




FRANCE






EU/2/09/096/001-002


Suspension for injection


QI06AA01


19.6.2009




25.6.2009


Leucofeligen FeLV/RCP


 







Virbac




1ère avenue




2065 m L.I.D.




06516 Carros Cedex




FRANCE






EU/2/09/097/001-002


Lyophilisate and solvent for suspension for injection


QI06AH07


29.6.2009




—   Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




4.6.2009


Rheumocam







Chanelle Pharmaceuticals Manufacturing Limited




Loughrea




Co. Galway




IRELAND






EU/2/07/078/001-004


8.6.2009




8.6.2009


Circovac







Merial




29 avenue Tony Garnier




69007 Lyon




FRANCE






EU/2/07/075/001-004


10.6.2009




22.6.2009


ProMeris







Fort Dodge Animal Health Holland




C.J. van Houtenlaan 36




1381 CP Weesp




NEDERLAND






EU/2/06/064/001-004


25.6.2009




30.6.2009


Posatex







Intervet International B.V.




Wim de Körverstraat 35




5831 AN Boxmeer




NEDERLAND









S-P Veterinary




Shire Park




Welwyn Garden City




Hertfordshire




AL7 1TW




UNITED KINGDOM






EU/2/08/081/001-003


2.7.2009




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




London




E14 4HB




UNITED KINGDOM






(1)  OJ L 136, 30.4.2004, p. 1.

(2)  OJ L 136, 30.4.2004, p. 1.