Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2011-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2011383EN.01000101.xml










30.12.2011   


EN


Official Journal of the European Union


C 383/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2011 to 31 October 2011

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

2011/C 383/01
—   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




2.9.2011


Vibativ


telavancin







Astellas Pharma Europe B.V.




Elisabethhof 19,




NL-2353 EW Leiderdorp,




Nederland






EU/1/11/705/001-002


powder for concentrate for solution for infusion


J01XA03


6.9.2011




2.9.2011


Votubia


Everolimus







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/710/001-007


Tablet


L01XE10


6.9.2011




5.9.2011


Zytiga


abiraterone







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/714/001


Tablet


L02BX03


7.9.2011




16.9.2011


Dexdor


dexmedetomidine







Orion Corporation




Orionintie 1,




FI-02200 Espoo,




Suomi






EU/1/11/718/001-006


Concentrate for solution for infusion


N05CM18


21.9.2011




19.9.2011


Incivo


telaprevir







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/720/001


Film-coated tablet


Pending


22.9.2011




30.9.2011


Pramipexole Accord


pramipexole







Accord Healthcare Limited




5th Floor Charles House, 108/110 Finchley road,




London




NW3 5JJ,




United Kingdom






EU/1/11/728/001-010


Tablet


N04BC05


4.10.2011




3.10.2011


Levetiracetam Accord


levetiracetam







Accord Healthcare Limited




5th Floor Charles House, 108/110 Finchley road,




London




NW3 5JJ,




United Kingdom






EU/1/11/712/001-028


Film-coated tablet


N03AX14


5.1.2011




3.10.2011


Levetiracetam Actavis


levetiracetam







Actavis Group PTC ehf.




Reykjavikurvegur 76-78,




220 Hafnarfjordur,




Iceland






EU/1/11/713/001-040


Film-coated tablet


N03AX14


5.10.2011




3.10.2011


Matever


levetiracetam







Pharmathen S.A.




6 Dervenakion,




15351 Pallini Attiki,




Ελλάδα






EU/1/11/711/001-030


Concentrate for solution for infusion
Film-coated tablet


N03AX14


6.10.2011




3.10.2011


Telmisartan Teva Pharma


telmisartan







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/11/719/001-060


Tablet


C09CA07


5.10.2011




27.10.2011


Eurartesim


dihydroartemisinin/piperaquine tetraphosphate







Sigma-Tau Industrie Farmaceutiche Riunite S.p.A




Viale Shakespeare 47,




00144 Rome,




Italia






EU/1/11/716/001-005


Film-coated tablet


P01BF05


2.11.2011







—   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




2.9.2011


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris,




France






EU/1/98/086/001-034


6.9.2011




2.9.2011


Lucentis







Novartis Europharm Ltd




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/06/374/001


6.9.2011




2.9.2011


Torisel







Wyeth Europa Ltd




Huntercombe Lane South, Taplow, Maidenhead,




Berkshire




SL6 0PH,




United Kingdom






EU/1/07/424/001


6.9.2011




5.9.2011


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19,




NL-2353 EW Leiderdorp,




Nederland






EU/1/07/387/001-026


7.9.2011




5.9.2011


Aflunov







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/658/001-002


7.9.2011




5.9.2011


Apidra







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/04/285/001-036


7.9.2011




5.9.2011


Cayston







Gilead Sciences International Limited




Granta Park, Abington,




Cambridge




CB21 6GT,




United Kingdom






EU/1/09/543/001-002


7.9.2011




5.9.2011


Insuman







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/97/030/028-195


7.9.2011




5.9.2011


ProQuad







Sanofi Pasteur MSD, SNC




8, rue Jonas Salk,




69007 Lyon,




France






EU/1/05/323/001-013


7.9.2011




5.9.2011


Removab







Fresenius Biotech GmbH




Am Haag 6-7,




D-82166 Graefelfing,




Deutschland






EU/1/09/512/001-002


7.9.2011




5.9.2011


Simponi







Janssen Biologics B.V.




Einsteinweg 101,




CB Leiden 2333,




Nederland






EU/1/09/546/001-004


7.9.2011




5.9.2011


Viracept







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/97/054/001
EU/1/97/054/004-005


7.9.2011




7.9.2011


CANCIDAS







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/01/196/001
EU/1/01/196/003


9.9.2011




7.9.2011


Circadin







RAD Neurim Pharmaceuticals EEC Limited




One Forbury Square, The Forbury, Reading,




Berkshire




RG1 3EB,




United Kingdom






EU/1/07/392/003


13.9.2011




7.9.2011


Irbesartan HCT Winthrop







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/06/377/001-028


9.9.2011




13.9.2011


Ammonaps







Swedish Orphan Biovitrum International AB




SE-11276 Stockholm,




Sverige






EU/1/99/120/003-004


15.9.2011




13.9.2011


Luminity







Lantheus MI UK Limited




Festival House - 39 Oxford Street - Newbury -




Berkshire




RG14 1JG -




United Kingdom






EU/1/06/361/001-002


15.9.2011




13.9.2011


Raloxifene Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/10/627/001-003


15.9.2011




13.9.2011


Synagis







Abbott Laboratories Ltd




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




Berkshire




SL6 4XE,




United Kingdom






EU/1/99/117/001-002


15.9.2011




13.9.2011


Xelevia







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/382/001-018


15.9.2011




13.9.2011


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/08/479/001-003


16.9.2011




16.9.2011


Aerius







Schering Plough Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique -




Stallestraat, 73 -




1180 Brussel,




België






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


21.9.2011




16.9.2011


Angiox







The Medicines Company UK Ltd




115 L Milton Park, Abingdon,




Oxfordshire,




OX14 4SA,




United Kingdom






EU/1/04/289/001


20.9.2011




16.9.2011


Azomyr







Schering Plough Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique -




Stallestraat, 73 -




1180 Brussel,




België






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


21.9.2011




16.9.2011


Azopt







Alcon Laboratories (UK) Ltd.




Pentagon Park, Boundary Way, Hemel Hempstead,




Herts




HP2 7UD,




United Kingdom






EU/1/00/129/001-003


20.9.2011




16.9.2011


Ilaris







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/09/564/001-003


20.9.2011




16.9.2011


Myclausen







Herbert J. Passauer GmbH & Co. KG




Stubenrauchstrasse 33,




14167 Berlin,




Deutschland






EU/1/10/647/001-004


20.9.2011




16.9.2011


Neoclarityn







Schering Plough Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique -




Stallestraat, 73 -




1180 Brussel,




België






EU/1/00/161/001-013
EU/1/00/161/022-067


21.9.2011




16.9.2011


NeuroBloc







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield,




Hertfordshire,




AL10 9SN,




United Kingdom






EU/1/00/166/001-003


20.9.2011




16.9.2011


Pandemrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart, B-1330




Belgique






EU/1/08/452/001


21.9.2011




16.9.2011


Resolor







Shire-Movetis NV




Veedjik 58 (1004),




B-2300 Turnhout,




Belgium






EU/1/09/581/001-008


21.9.2011




16.9.2011


Suboxone







RB Pharmaceuticals Limited




103-105 Bath Road, Slough,




Berkshire,




SL1 3UH,




United Kingdom






EU/1/06/359/001-004


20.9.2011




16.9.2011


Viramune







Boehringer Ingelheim International GmbH




Binger Strasse 173-




D - 55216 Ingelheim am Rhein,




Deutschland






EU/1/97/055/001-009


26.9.2011




19.9.2011


Byetta







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/06/362/001-004


22.9.2011




19.9.2011


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/07/384/001-005


22.9.2011




19.9.2011


Ifirmasta







KRKA, d.d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/08/480/001-018


22.9.2011




19.9.2011


Temomedac







medac Gesellschaft für klinische Spezialpräparate mbH




Fehlandtstrasse 3,




D-20354 Hamburg –




Deutschland






EU/1/09/605/001-012


22.9.2011




19.9.2011


Zonegran







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield,




Hertfordshire,




AL10 9SN,




United Kingdom






EU/1/04/307/001-021


22.9.2011




22.9.2011


Clopidogrel DURA







Mylan dura GmbH




Wittichstraße 6,




D-64295 Darmstadt,




Deutschland






EU/1/09/560/001-009


26.9.2011




22.9.2011


Ixiaro







Intercell AG




Campus Vienna Biocenter 3




A-1030 Wien,




Österreich






EU/1/08/501/001-002


26.9.2011




22.9.2011


Leflunomide ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/10/654/001-004


26.9.2011




22.9.2011


Pergoveris







Merck Serono Europe Limited




56, Marsh Wall,




London




E14 9TP,




United Kingdom






EU/1/07/396/001-003


26.9.2011




22.9.2011


RoActemra







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/08/492/001-006


26.9.2011




22.9.2011


Taxotere







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/95/002/001-005


27.9.2011




30.9.2011


Aerinaze







SP Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique -




Stallestraat, 73 -




1180 Brussel,




België






EU/1/07/399/001-006


4.10.2011




3.10.2011


Elaprase







Shire Human Genetic Therapies AB




Svärdvägen 11D,




18233 Danderyd,




Sverige






EU/1/06/365/001-003


5.10.2011




3.10.2011


Lysodren







Laboratoire HRA Pharma




15, rue Béranger,




75003 Paris,




France






EU/1/04/273/001


5.10.2011




3.10.2011


Sprycel







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/06/363/001-015


5.10.2011




3.10.2011


Xagrid







Shire Pharmaceutical Contracts Ltd




Hampshire International Business Park, Chineham, Basingstoke,




Hampshire




RG24 8EP,




United Kingdom






EU/1/04/295/001


5.10.2011




6.10.2011


NeoRecormon







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/97/031/001-046


10.10.2011




6.10.2011


Noxafil







SP Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique -




Stallestraat, 73 -




1180 Brussel,




België






EU/1/05/320/001


10.10.2011




6.10.2011


Sildenafil Actavis







Actavis Group PTC ehf.




Reykjavikurvegur 76-78,




220 Hafnarfjordur,




Iceland






EU/1/09/595/001-015


10.10.2011




6.10.2011


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


10.10.2011




6.10.2011


Topotecan Hospira







Hospira UK Limited




Queensway, Royal Leamington Spa,




Warwickshire




CV31 3RW,




United Kingdom






EU/1/10/633/001-002


10.10.2011




12.10.2011


Celsentri







ViiV Healthcare UK Ltd




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






EU/1/07/418/001-010


13.10.2011




12.10.2011


Galvus







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






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


14.10.2011




12.10.2011


Invega







Janssen-Cilag International NV




Turnhoutseweg, 30 -




2340 Beerse –




België






EU/1/07/395/001-095


14.10.2011




12.10.2011


Jalra







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/485/001-011


14.10.2011




12.10.2011


Rilonacept Regeneron







Regeneron UK Limited




40 Bank Street,




London,




E14 5DS




United Kingdom






EU/1/09/582/001


14.10.2011




12.10.2011


Stelara







Janssen-Cilag International NV




Turnhoutseweg, 30 -




2340 Beerse –




België






EU/1/08/494/001-004


14.10.2011




12.10.2011


Teysuno







Taiho Pharma Europe, Limited




55 Colmore Row, Birmingham,




West Midlands,




B3 2AS,




United Kingdom






EU/1/11/669/001-004


14.1.2011




12.10.2011


Xeplion







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/672/001-006


14.10.2011




12.10.2011


Xiliarx







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/486/001-011


14.10.2011




17.10.2011


Docetaxel Teva







Teva Pharma B.V.




Computerweg 10,




3542 DR Utrecht,




Nederland






EU/1/09/611/001-002


19.10.2011




20.10.2011


Arixtra







Glaxo Group Ltd.




Greenford Road, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/02/206/001-035


24.10.2011




20.10.2011


Karvezide







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road,




Uxbridge




UB8 1DH,




United Kingdom






EU/1/98/085/001-034


24.10.2011




20.10.2011


Mircera







Roche Registration Limited




6 Falcon Way, Shire Park,




Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/07/400/008-013
EU/1/07/400/017-024


24.10.2011




20.10.2011


Naglazyme







BioMarin Europe Ltd




164 Shaftesbury Avenue,




London




WC2H 8HL,




United Kingdom






EU/1/05/324/001-002


24.10.2011




20.10.2011


Zypadhera







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/08/479/001-003


24.10.2011




20.10.2011


Zyprexa







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/96/022/002
EU/1/96/022/004
EU/1/96/022/006
EU/1/96/022/009-012
EU/1/96/022/014
EU/1/96/022/016-017
EU/1/96/022/019-040


28.9.2011




20.10.2011


Zyprexa Velotab







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/99/125/001-020


28.9.2011




24.10.2011


Alimta







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/04/290/001-002


26.10.2011




24.10.2011


Avonex







Biogen Idec Ltd




Innovation House,




70 Norden Road, Maidenhead,




Berkshire




SL6 4AY,




United Kingdom






EU/1/97/033/002-006


26.10.2011




24.10.2011


CoAprovel







Sanofi Pharma Bristol-Myers Squibb SNC




174 avenue de France -




75013 Paris,




France






EU/1/98/086/001-034


26.10.2011




24.10.2011


Daxas







Nycomed GmbH




Byk-Gulden-Str. 2,




D-78467 Konstanz,




Deutschland






EU/1/10/636/001-007


26.10.2011




24.10.2011


Docetaxel Winthrop







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/07/384/001-005


26.10.2011




24.10.2011


Ebixa







H. Lundbeck A/S




Ottiliavej 9,




DK-2500 Valby,




Danmark






EU/1/02/219/001-049


26.10.2011




24.10.2011


Efient







Eli Lilly Nederland B.V.




Grootslag 1-5,




3991 RA Houten,




Nederland






EU/1/08/503/001-016


26.10.2011




24.10.2011


Emend







Merck Sharp & Dohme Ltd




Hertford Road, Hoddesdon,




Hertfordshire




EN11 9BU,




United Kingdom






EU/1/03/262/001-008


27.10.2011




24.10.2011


Erbitux







Merck KGaA




Frankfurter Straße 250,




64271 Darmstadt,




Deutschland






EU/1/04/281/001-005


26.10.2011




24.10.2011


Humira







Abbott Laboratories Ltd




Abbott House, Vanwall Business Park,




Vanwall Road, Maidenhead,




Berkshire




SL6 4XE,




United Kingdom






EU/1/03/256/001-010


26.10.2011




24.10.2011


Icandra







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/484/001-018


26.10.2011




24.10.2011


IntronA







Schering Plough Europe




Rue de Stalle, 73,




1180 Bruxelles,




Belgique -




Stallestraat, 73 -




1180 Brussel,




België






EU/1/99/127/011-039
EU/1/99/127/041-044


27.10.2011




24.10.2011


Irbesartan HCT Winthrop







Sanofi-Aventis




174, avenue de France,




F-75013 Paris,




France






EU/1/06/377/001-028


26.10.2011




24.10.2011


Keppra







UCB Pharma SA.




Allée de la Recherche 60,




1070 Bruxelles,




Belgique/




Researchdreef, 60,




Brussel 1070,




België






EU/1/00/146/001-032


26.10.2011




24.10.2011


Kivexa







ViiV Healthcare UK Ltd




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






EU/1/04/298/001-003


26.10.2011




24.10.2011


Levemir







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/04/278/001-016


26.10.2011




24.10.2011


Lyrica







Pfizer Ltd




Ramsgate Road,




Sandwich,




Kent




CT 139NJ,




United Kingdom






EU/1/04/279/001-044


26.10.2011




24.10.2011


Nexavar







Bayer Pharma AG




Berlin 13342,




Deutschland






EU/1/06/342/001


26.10.2011




24.10.2011


Onglyza







Bristol Myers Squibb/AstraZeneca EEIG




Bristol Myers Squibb House,




Uxbridge Business Park,




Sanderson Road, Uxbridge,




Middlesex




UB8 1DH,




United Kingdom






EU/1/09/545/001-015


26.10.2011




24.10.2011


Prevenar 13







Wyeth-Lederle Vaccines S.A.




Pleinlaan 17 Boulevard de la Plaine,




1050 Brussels - Bruxelles,




Belgïe-Belgique






EU/1/09/590/001-006


26.10.2011




24.10.2011


Revatio







Pfizer Limited




Sandwich,




Kent,




CT13 9NJ,




United Kingdom






EU/1/05/318/001


26.10.2011




24.10.2011


Rotarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




Rixensart,




B-1330




Belgique






EU/1/05/330/001-011


26.10.2011




24.10.2011


Starlix







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/01/174/001-021


26.10.2011




24.10.2011


Sycrest







N.V. Organon




Kloosterstraat 6,




5349 AB Oss,




Nederland






EU/1/10/640/001-006


26.10.2011




24.10.2011


Toviaz







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/1/07/386/001-018


26.10.2011




24.10.2011


Votrient







Glaxo Group Limited




Berkeley Avenue, Greenford,




Middlesex




UB6 0NN,




United Kingdom






EU/1/10/628/001-004


26.10.2011




24.10.2011


Ziagen







ViiV Healthcare UK Ltd




980 Great West Road, Brentford,




Middlesex,




TW8 9GS,




United Kingdom






EU/1/99/112/001-002


26.10.2011




27.10.2011


Advagraf







Astellas Pharma Europe B.V.




Elisabethhof 19,




NL-2353 EW Leiderdorp,




Nederland






EU/1/07/387/001-026


4.11.2011




27.10.2011


Axura







Merz Pharmaceuticals GmbH




Eckenheimer Landstr. 100,




D-60318 Frankfurt/Main –




Deutschland






EU/1/02/218/001-003
EU/1/02/218/005-030


4.11.2011




27.10.2011


Ceprotin







Baxter AG




Industriestraße 67,




A - 1221 Wien,




Österreich






EU/1/01/190/001-002


4.11.2011




27.10.2011


Eucreas







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/425/001-018


4.11.2011




27.10.2011


Exalief







BIAL - Portela & Ca, SA




A Av. da Siderurgia Nacional




4745-457 S. Mamede do Coronado –




Portugal






EU/1/09/520/001-020


4.11.2011




27.10.2011


Galvus







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






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


4.11.2011




27.10.2011


Jalra







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/485/001-011


4.11.2011




27.10.2011


Leflunomide Winthrop







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/09/604/001-010


1.11.2011




27.10.2011


Mixtard







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/231/030-032


1.11.2011




27.10.2011


Rapiscan







Rapidscan Pharma Solutions EU Ltd.




Regent's Place, 338 Euston Road,




London




NW1 3BT,




UK






EU/1/10/643/001


4.11.2011




27.10.2011


Rasilamlo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/686/001-056


4.11.2011




27.10.2011


Riprazo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/409/001-040


1.11.2011




27.10.2011


Riprazo HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/680/001-080


4.11.2011




27.10.2011


Sprimeo







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/07/407/001-040


1.11.2011




27.10.2011


Sprimeo HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham,




West Sussex,




RH12 5AB,




United Kingdom






EU/1/11/683/001-080


4.11.2011




27.10.2011


Taxotere







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony Cedex,




France






EU/1/95/002/001-005


4.11.2011




27.10.2011


Tygacil







Wyeth Europa Ltd.




Huntercombe Lane South, Taplow, Maidenhead,




Berkshire,




SL6 0PH,




United Kingdom






EU/1/06/336/001


4.11.2011




27.10.2011


Xiliarx







Novartis Europharm Ltd




Wimblehurst Road, Horsham,




West Sussex




RH12 5AB,




United Kingdom






EU/1/08/486/001-011


4.11.2011







—   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




3.10.2011


Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals







GlaxoSmithKline Biologicals S.A.




Rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/08/478/001


5.10.2011




17.10.2011


Ablavar







TMC Pharma Services Ltd.




Lodge Farm Barn, Elvetham Park Estate,




Fleet Road, Hartley Wintney,




Hampshire,




RG27 8AS,




United Kingdom






EU/1/05/313/001-009


19.10.2011







—   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




7.9.2011


Nobivac Myxo-RHD


Live myxoma vectored RHD virus strain 009







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/11/132/001-004


Lyophilisate and solvent for suspension for injection


QI08AD


9.9.2011




13.9.2011


Recocam


Meloxicam







CF Pharma Limited




Unit 622, Northern Extension,




Waterford,




Ireland






EU/2/11/133/001-003


Solution for injection


QM01AC06


15.9.2011




6.10.2011


Recuvyra


Fentanyl







Nexcyon Pharmaceuticals Ltd.




Bank Barn, How Mill,




Brampton,




Cumbria




CA8 9JY,




UNITED KINGDOM






EU/2/11/127/001


Transdermal solution


QN02AB03


11.10.2011







—   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




5.9.2011


Improvac







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/09/095/001-006


7.9.2011




13.9.2011


Cortavance







VIRBAC S.A.




1ère Avenue 2065 m L.I.D. -




06516 Carros –




France






EU/2/06/069/001


15.9.2011




16.9.2011


Loxicom







Norbrook Laboratories Limited




Station Works, Newry,




Co. Down,




BT35 6JP,




United Kindgom






EU/2/08/090/001-026


20.9.2011




16.9.2011


Porcilis Pesti







Intervet International B.V.




Wim de Körverstraat 35,




5831 AN Boxmeer,




Nederland






EU/2/99/016/001-006


21.9.2011




19.9.2011


ZULVAC 1+8 Ovis







Pfizer Limited




Ramsgate Road, Sandwich,




Kent




CT13 9NJ,




United Kingdom






EU/2/11/120/001-003


22.9.2011




20.10.2011


Suprelorin







VIRBAC S.A.




1ère Avenue 2065 m L.I.D. -




06516 Carros –




France






EU/2/07/072/003-004


24.10.2011




24.10.2011


Meloxoral







Le Vet B.V.




Wilgenweg 7,




3421 TV




Oudewater,




Nederland






EU/2/10/111/001-007


26.10.2011




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.