Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 2009 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council )
Date: 2009-11-27
Institutions: European Commission
Subjects: EU Member State, market approval, marketing standard, medicinal product, pharmaceutical legislation, pharmaceutical product








C_2009288EN.01000101.xml










27.11.2009   


EN


Official Journal of the European Union


C 288/1





Summary of Community decisions on marketing authorizations in respect of medicinal products from 1 October 2009 to 31 October 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 288/01
—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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




1.10.2009


Onglyza


Saxagliptin


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


EU/1/09/545/001-010


Film-coated tablet


A10BH03


5.10.2009




1.10.2009


Cimzia


certolizumab pegol


UCB Pharma SA., Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, België


EU/1/09/544/001-002


Solution for injection


L04AB05


6.10.2009




1.10.2009


Simponi


golimumab


Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/09/546/001-004


Solution for injection in pre-filled pen


L04AB06


6.10.2009




5.10.2009


ChondroCelect


Characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins


TiGenix NV, Romeinse straat 12/2, B-3001 Leuven, België


EU/1/09/563/001


Implantation suspension


Non applicable


7.10.2009




14.10.2009


Enyglid


Repaglinide


KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/580/001-018


Tablet


A10B X02


16.10.2009




15.10.2009


Resolor


prucalopride


Movetis NV, Veedijk 58, B-2300 Turnhout, België


EU/1/09/581/001-002


Film-coated tablets


A03AE04


19.10.2009




15.10.2009


Imprida HCT


amlodipine besylate / valsartan / hydrochlorothiazide


Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/570/001-060


Film-coated tablet


C09DX01


19.10.2009




16.10.2009


Clopidogrel MYLAN Pharma


Clopidogrel


Mylan S.A.S, 117 allee des Parcs, 69800 Saint Priest, France


EU/1/09/568/001-018


Film-coated tablet


B01AC-04


20.10.2009




16.10.2009


PANDEMIC INFLUENZA VACCINE H5N1 BAXTER


Pandemic influenza vaccine (H5N1 whole virion, Vero cell derived, inactivated)


Baxter AG, Industriestraße 67, A - 1221 Wien, Österreich


EU/1/09/571/001


Suspension for injection


J07BB01


20.10.2009




16.10.2009


Exforge HCT


amlodipine besylate / valsartan / hydrochlorothiazide


Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/569/001-060


Film-coated tablet


C09DX01


20.10.2009




16.10.2009


ALENDRONATE SODIUM AND COLECALCIFEROL, MSD


alendronic acid / colecalciferol


Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/09/572/001-009


Tablet


M05BB03


20.10.2009




19.10.2009


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


Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14


GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/09/578/001


Suspension and Emulsion for emulsion for injection


J07BB02


21.10.2009




19.10.2009


Foclivia


A/Viet Nam/1194/2004 (H5N1) virus surface inactivated antigen


Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina, 1 - Siena, Italia


EU/1/09/577/001-004


Suspension for injection


J07BB02


21.10.2009




23.10.2009


Lamivudine Teva


Lamivudine


Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/09/566/001-005


Film-coated tablet


J05AF05


27.10.2009




23.10.2009


Biopoin


epoetin theta


CT Arzneimittel GmbH, Lengeder Straße 42a, D-13407 Berlin, Deutschland


EU/1/09/565/001-028


Solution for injection


B03XA01


27.10.2009




23.10.2009


ARCALYST


Rilonacept


Regeneron UK Limited, 40 Bank Street, E14 5DS London, United Kingdom


EU/1/09/582/001


Powder and solvent for solution for injection


L04AC04


27.10.2009




23.10.2009


ILARIS


Canakinumab


Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/09/564/001-002


Powder for solution for injection


L04AC08


27.10.2009




29.10.2009


Eporatio


epoetin theta


ratiopharm GmbH, Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/09/573/001-028


Solution for injection


B03XA01


2.11.2009




30.10.2009


Irbesartan Teva


Irbesartan


Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/09/576/001-039


Film-coated tablet


C09C A04


4.11.2009




—   Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004): 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




1.10.2009


Epoetin alfa Hexal


Hexal AG., Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/07/411/021-026


5.10.2009




1.10.2009


Mixtard


Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/231/001-037


5.10.2009




1.10.2009


Protaphane


Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/234/001-017


5.10.2009




1.10.2009


Insulatard


Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/233/001-017


5.10.2009




1.10.2009


Actrapid


Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/230/001-017


5.10.2009




1.10.2009


Actraphane


Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/229/001-037


6.10.2009




1.10.2009


Binocrit


Sandoz GmbH, Biochemiestrasse 10, Kundl 6250, Österreich


EU/1/07/410/021-026


5.10.2009




2.10.2009


Tasmar


Meda AB, Pipers väg 2A, Solna 170 09, Sverige


EU/1/97/044/001-008


6.10.2009




6.10.2009


CELVAPAN


Baxter AG, Industriestraße 67, 1221 Wien, Österreich


EU/1/08/506/001


8.10.2009




7.10.2009


Agenerase


Glaxo Group Limited, Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/00/148/001-004


9.10.2009




7.10.2009


IntronA


Schering Plough Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België


EU/1/99/127/031-039


9.10.2009




8.10.2009


Mirapexin


Boehringer Ingelheim International GmbH, Binger Strasse 173- D - 55216 Ingelheim am Rhein, Deutschland


EU/1/97/051/013-027


12.10.2009




8.10.2009


Sifrol


Boehringer Ingelheim International GmbH, Binger Strasse 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/97/050/013-027


12.10.2009




8.10.2009


Nplate


Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland


EU/1/08/497/001-004


12.10.2009




8.10.2009


Circadin


RAD Neurim Pharmaceuticals EEC Limited, One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom


EU/1/07/392/001-002


12.10.2009




13.10.2009


NovoMix


Novo Nordisk A/S, Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/00/142/004-005
EU/1/00/142/009-022


15.10.2009




13.10.2009


Olanzapine Neopharma


Neopharma Limited, 57 High Street, Odiham, Hampshire RG29 1LF, United Kingdom


EU/1/07/426/001-011


15.10.2009




13.10.2009


CellCept


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


EU/1/96/005/001-006


15.10.2009




13.10.2009


Kinzalkomb


Bayer Schering Pharma AG, D-13342 Berlin, Deutschland


EU/1/02/214/001-015


15.10.2009




14.10.2009


alli


Glaxo Group Limited, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/07/401/001-006


16.10.2009




14.10.2009


Onsenal


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


EU/1/03/259/001-006


16.10.2009




14.10.2009


PritorPlus


Bayer Schering Pharma AG, 13342 Berlin, Deutschland


EU/1/02/215/001-021


16.10.2009




14.10.2009


Ammonaps


Swedish Orphan International AB, Drottninggatan 98, 111 60 Stockholm, Sverige


EU/1/99/120/001-004


19.10.2009




15.10.2009


Nexavar


Bayer Schering Pharma AG, 13342 Berlin, Deutschland


EU/1/06/342/001


19.10.2009




16.10.2009


Helixate NexGen


Bayer Schering Pharma AG, 13342 Berlin, Deutschland


EU/1/00/144/001-004


20.10.2009




16.10.2009


Aptivus


Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland


EU/1/05/315/001-002


20.10.2009




16.10.2009


KOGENATE Bayer


Bayer Schering Pharma AG, 13342 Berlin, Deutschland


EU/1/00/143/001-011


20.10.2009




19.10.2009


Thalidomide Celgene


Celgene Europe Limited, Riverside House, Riverside Walk, Windsor SL4 1NA, United Kingdom


EU/1/08/443/001


21.10.2009




19.10.2009


Ribavirin Teva Pharma BV


Teva Pharma B.V., Computerweg 10, 3542 DR Utrecht, Nederland


EU/1/09/527/001-016


21.10.2009




19.10.2009


Revlimid


Celgene Europe Limited, Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United Kingdom


EU/1/07/391/001-004


21.10.2009




19.10.2009


Prepandrix


GlaxoSmithKline Biologicals s.a., rue de l'Institut 89, Rixensart, 1330 Belgique


EU/1/08/453/002


21.10.2009




19.10.2009


Wilzin


Orphan Europe S.a.r.l., Immeuble Le Wilson, 70 Avenue du Général de Gaulle, 92800 Puteaux, France


EU/1/04/286/001-002


21.10.2009




19.10.2009


Olanzapine Teva


Teva Pharma B.V., Computerweg 10, DR Utrecht 3542,Nederland


EU/1/07/427/001-057


21.10.2009




20.10.2009


Vidaza


Celgene Europe Ltd, Riverside House, Riverside Walk, Windsor, SL4 1NA, United Kingdom


EU/1/08/488/001


22.10.2009




21.10.2009


Xarelto


Bayer Schering Pharma AG, 13342 Berlin, Deutschland


EU/1/08/472/001-008


23.10.2009




21.10.2009


Metalyse


Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland


EU/1/00/169/004-006


23.10.2009




21.10.2009


Filgrastim Hexal


HEXAL AG, Industriestrasse 25, 83607 Holzkirchen, Deutschland


EU/1/08/496/001-008


26.10.2009




21.10.2009


Zarzio


Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/08/495/001-008


23.10.2009




23.10.2009


Rebif


Merck Serono Europe Limited, 56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/98/063/001-010


27.10.2009




23.10.2009


Prezista


Janssen-Cilag International NV, Turnhoutseweg, 30 - 2340 Beerse – België


EU/1/06/380/001-005


27.10.2009




23.10.2009


Olanzapine Mylan


Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/08/475/001-034


27.10.2009




23.10.2009


Norvir


Abbott Laboratories Ltd, Queenborough, Kent ME11 5EL, United Kingdom


EU/1/96/016/001
EU/1/96/016/003-004


27.10.2009




23.10.2009


PEGASYS


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


EU/1/02/221/001-010


27.10.2009




23.10.2009


Invanz


Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/02/216/001-002


27.10.2009




23.10.2009


Procoralan


Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/05/316/001-014


27.10.2009




23.10.2009


Teslascan


GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway


EU/1/97/040/001-002


27.10.2009




23.10.2009


Vistide


Gilead Sciences International Limited, Cambridge, CB21 6GT, United Kingdom


EU/1/97/037/001


27.10.2009




23.10.2009


RotaTeq


Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, Lyon 69007, France


EU/1/06/348/001-002


27.10.2009




23.10.2009


Tamiflu


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


EU/1/02/222/001-004


27.10.2009




23.10.2009


Corlentor


Les Laboratoires Servier, 22, rue Garnier, 92200 Neuilly-sur-Seine, France


EU/1/05/317/001-014


27.10.2009




23.10.2009


Neulasta


Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland


EU/1/02/227/001-004


27.10.2009




23.10.2009


Ellaone


Laboratoire HRA Pharma, 15, rue Béranger, 75003 Paris, France


EU/1/09/522/001


27.10.2009




28.10.2009


Xelevia


Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/382/001-018


30.10.2009




28.10.2009


TESAVEL


Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/07/435/001-018


30.10.2009




28.10.2009


Pradaxa


Boehringer Ingelheim International GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, Deutschland


EU/1/08/442/001-008


2.11.2009




28.10.2009


Aranesp


Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, Nederland


EU/1/01/185/001-022
EU/1/01/185/031-099


30.10.2009




28.10.2009


Zerit


Bristol-Myers Squibb Pharma EEIG, Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/96/009/001-009


30.10.2009




28.10.2009


Arava


Sanofi-Aventis Deutschland GmbH, 65926 Frankfurt am Main, Deutschland


EU/1/99/118/001-010


30.10.2009




28.10.2009


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


30.10.2009




28.10.2009


Myozyme


Genzyme Europe B.V., Gooimeer 10, 1411 DD Naarden, Nederland


EU/1/06/333/001-003


2.11.2009




28.10.2009


SUTENT


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


EU/1/06/347/001-008


30.10.2009




28.10.2009


Integrilin


Glaxo Group Ltd, Greenford, Middlesex, UB6 ONN, United Kingdom


EU/1/99/109/001-002


30.10.2009




28.10.2009


BeneFIX


Wyeth Europa Ltd., Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United Kingdom


EU/1/97/047/001-007


30.10.2009




28.10.2009


RoActemra


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


EU/1/08/492/001-006


30.10.2009




28.10.2009


Beromun


Boehringer Ingelheim International GmbH, Binger Strasse 173- 55216 Ingelheim am Rhein, Deutschland


EU/1/99/097/001


2.11.2009




28.10.2009


Epivir


Glaxo Group Ltd., Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom


EU/1/96/015/001-005


30.10.2009




28.10.2009


IXIARO


Intercell AG, Campus Vienna Biocenter 3 A-1030 Wien, Österreich


EU/1/08/501/001-002


30.10.2009




28.10.2009


Efficib


Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/457/001-016


30.10.2009




28.10.2009


Janumet


Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/455/001-016


30.10.2009




28.10.2009


Noxafil


SP Europe, Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, België


EU/1/05/320/001


30.10.2009




28.10.2009


Velcade


Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, België


EU/1/04/274/001-002


30.10.2009




28.10.2009


Zostavax


Sanofi Pasteur MSD, SNC, 8, rue Jonas Salk, 69007 Lyon, France


EU/1/06/341/001-013


30.10.2009




28.10.2009


Velmetia


Merck Sharp & Dohme Ltd., Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/456/001-016


30.10.2009




29.10.2009


Sebivo


Novartis Europharm Limited, Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/07/388/001-003


2.11.2009




29.10.2009


ADROVANCE


Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/06/364/001-009


2.11.2009




29.10.2009


Remicade


Centocor B.V., Einsteinweg 101, 2333 CB Leiden, Nederland


EU/1/99/116/001-005


2.11.2009




29.10.2009


INOmax


INO Therapeutics AB, SE-181 81 Lidingö, Sverige


EU/1/01/194/001-002


3.11.2009




30.10.2009


Xagrid


Shire Pharmaceutical Contracts Ltd, Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295/001


4.11.2009




30.10.2009


Zalasta


KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/07/415/001-056


4.11.2009




30.10.2009


Insulin Human Winthrop


Sanofi-Aventis Deutschland GmbH, D-65926 Frankfurt am Main, Deutschland


EU/1/06/368/001-168


4.11.2009




—   Lift of suspension of a marketing authorization (Article 20 of Regulation (EC) No 726/2004)










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




8.10.2009


Optison


GE Healthcare AS, Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 Oslo, Norway


EU/1/98/065/001-002


12.10.2009




—   Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004): 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




1.10.2009


Oxyglobin


Biopure Netherlands B.V., Parnassustoren, Locatellikade 1, 1076 AZ Amsterdam, Nederland


EU/2/99/015/001-002


5.10.2009




1.10.2009


Stronghold


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


EU/2/99/014/001-012


5.10.2009




6.10.2009


Nobilis Influenza H5N2


Intervet International B.V., Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland


EU/2/06/061/001-004


8.10.2009




8.10.2009


Naxcel


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


EU/2/05/053/003


12.10.2009




8.10.2009


Rheumocam


Chanelle Pharmaceuticals Manufacturing Limited, Loughrea, Co. Galway, IRELAND


EU/2/07/078/005-008


12.10.2009




8.10.2009


Meloxidyl


CEVA SANTE ANIMALE, Z.I. la Ballastière, 33500 Libourne, France


EU/2/06/070/004


12.10.2009




21.10.2009


Suprelorin


VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France


EU/2/07/072/001-002


23.10.2009




30.10.2009


Easotic


VIRBAC S.A., 1ère Avenue 2065 m L.I.D. - 06516 Carros – France


EU/2/08/085/001


4.11.2009




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 of 30.4.2004, p. 1.