Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od 1 marzec 2010 do 30 czerwiec 2010.

Dzienniki UE

Dz.U.UE.C.2010.258.1

Akt nienormatywny
Wersja od: 24 września 2010 r.

Zestawienie decyzji Unii Europejskiej w sprawie pozwoleń na dopuszczenie do obrotu produktów leczniczych w okresie od 1 marzec 2010 do 30 czerwiec 2010

[Opublikowano zgodnie z art. 13 lub art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady(1)]

(2010/C 258/01)

(Dz.U.UE C z dnia 24 września 2010 r.)

– Wydanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie

Data wydania decyzjiNazwa produktu leczniczegoINN (międzynarodowa niezastrzeżona nazwa)Posiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymPostać farmaceutycznaKod ATC (klasyfikacja anatomiczno-terapeutyczno-chemiczna)Data notyfikacji
11.3.2010RevoladeEltrombopaguGlaxoSmithKline Trading Services Limited

6900 Cork Airport Business Park,

Kinsale Road, Cork, Ireland

EU/1/10/612/001-006Tabletka powlekanaB02BX0515.3.2010
15.3.2010DuoCoverKlopidogrel/Kwas acetylosalicylowyBristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United KingdomEU/1/10/623/001-014Tabletka powlekanaB01AC3017.3.2010
15.3.2010DuoPlavinKlopidogrel/Kwas acetylosalicylowySanofi Pharma Bristol-Myers Squibb SNC

174 Avenue de France, F-75013 Paris, France

EU/1/10/619/001-014Tabletka powlekanaB01AC3017.3.2010
15.3.2010ImmunoGamImmunoglobulina ludzka przeciw wirusowi zapalenia wątroby typu BCangene Europe Limited Parkshot House, 5 Kew Road, Richmond, Surrey TW9 2PR, United KingdomEU/1/10/613/001-002Roztwór do wstrzykiwańJ06BB0417.3.2010
15.3.2010MenveoSzczepionka skoniugowana przeciwko meningokokom grupy A, C, W135 i YNovartis Vaccines and Diagnostics

S.r.l.

Via Fiorentina, 1 - Siena, Italia

EU/1/10/614/001Proszek i roztwór do sporządzania roztworu do wstrzykiwańPending17.3.2010
15.3.2010RistabenSitagliptinMerck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United KingdomEU/1/10/621/001-018Tabletka powlekanaA10BH0117.3.2010
15.3.2010Ristforsitagliptyna / metforminy chlorowodorekMerck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United KingdomEU/1/10/620/001-016Tabletka powlekanaA10BD0717.3.2010
15.3.2010Temozolomide HEXALtemozolomiduHEXAL AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616/001-024Kapsułki, twardeL01AX0317.3.2010
15.3.2010Temozolomide HospiratemozolomiduHospira UK Ltd. Queensway, Royal Leamington Spa, Royal Leamington Spa, Warwickshire CV31 3RW, United KingdomEU/1/10/615/001-024Kapsułki, twardeL01AX0317.3.2010
15.3.2010Temozolomide SandoztemozolomiduSandoz Pharmaceuticals GmbH Raiffeisenstraße 11, 83607 Holzkirchen, DeutschlandEU/1/10/617/001-024Kapsułki, twardeL01AX0317.3.2010
15.3.2010TepadinaTiotepaADIENNE S.r.l.

via Broseta, 64/B, 24128 Bergamo,

Italia

EU/1/10/622/001-002Proszek do przygotowania koncentratu do sporządzania roztworu do infuzjiL01AC0117.3.2010
23.3.2010ArepanrixPandemiczna szczepionka przeciw grypie (H1N1) (rozszczepiony wirion) inaktywowana, z adiuwantem A/California/7/2009 wariant szczepu (H1N1)v (X-179A)GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixen-sart, BelgiqueEU/1/10/624/001Zawiesina i emulsja do sporządzania emulsji do wstrzykiwańJ07BB0225.3.2010
6.4.2010Ribavirin BioPartnersRybawirynaBioPartners GmbH Kaiserpassage 11 - D-72764 Reutlingen, DeutschlandEU/1/10/626/001-004Tabletka powlekanaJ05AB049.4.2010
19.4.2010ArzerraOfatumumabGlaxo Group Ltd Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex UB6 0NN, United KingdomEU/1/10/625/001-002Koncentrat do sporządzania roztworu do infuzjiL01XC1021.4.2010
29.4.2010Raloxifene TevaRaloxifeni hydrochloridumTeva Pharma B.V. Computerweg 10, 3542 DR Utrecht, NederlandEU/1/10/627/001-003Tabletka powlekanaG03XC013.5.2010
10.5.2010DocefrezdocetakselSun Pharmaceuticals Industries Europe B.V.

Polarisavenue 87, 2132 JH Hoofd-dorp, Nederland

EU/1/10/630/001-002w proszku i rozpuszczalnik do sporządzania koncentratu do sporządzania roztworu do infuzjiL01CD0212.5.2010
26.5.2010ProliadenozumabAmgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, NederlandEU/1/10/618/001-004Roztwór do wstrzykiwańM05BX0428.5.2010
4.6.2010ToluratelmisartanKRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/10/632/001-021TabletkiC09CA078.6.2010
8.6.2010HumenzaPandemiczna szczepionka przeciw grypie (H1N1) (rozszczepiony wirion) inaktywowana, z adiuwantem A/California/7/2009 wariant szczepu (H1N1)v (X-179A)Sanofi Pasteur SA

2, avenue Pont Pasteur, F-69007

Lyon, France

EU/1/10/629/001Zawiesina i emulsja do sporządzania emulsji do wstrzykiwańJ07BB0210.6.2010
8.6.2010NivestimFilgrastymHospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United KingdomEU/1/10/631/001-009Roztwór do wstrzykiwań lub infuzjiL03AA0210.6.2010
10.6.2010Olanzapine ApotexOlanzapinaApotex Europe B.V. Darwingweg 20, 2333 CR Leiden, NederlandEU/1/10/635/001-014Tabletka powlekana Tabletki ulegające rozpadowi w jamie ustnejN05AH0314.6.2010
10.6.2010Ribavirin Three RiversRybawirynaThree Rivers Global Pharma Limited

20-22 Bedford Row, London WC1R4JS, United Kingdom

EU/1/10/634/001-004Kapsułki, twardeJ05AB0414.6.2010
10.6.2010Topotecan HospiraTopotekanHospira UK Limited Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United KingdomEU/1/10/633/001-002Koncentrat do sporządzania roztworu do infuzjiL01XX1714.6.2010
14.6.2010VotrientChlorowodorek pazopanibuGlaxo Group Limited Berkeley Avenue, Greenford, Middlesex UB6 0NN, United KingdomEU/1/10/628/001-004Tabletka powlekanaL01XE1116.6.2010

– Wydanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Odrzucenie

Data wydania decyzjiNazwa produktu leczniczegoPosiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymData notyfikacji
8.4.2010ImpulsorPierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billan-court Cedex, France12.4.2010
8.4.2010Milnacipran Pierre Fabre MedicamentPierre Fabre Médicament 45, Place Abel Gance, 92654 Boulogne Billan-court Cedex, France12.4.2010

– Zmiana pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie

Data wydania decyzjiNazwa produktu leczniczegoPosiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymData notyfikacji
11.3.2010CancidasMerck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United KingdomEU/1/01/196/001

EU/1/01/196/003

15.3.2010
11.3.2010DafiroNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/371/001-03615.3.2010
11.3.2010DiacomitBiocodex

7 avenue Gallieni, 94250

Gentilly, France

EU/1/06/367/001-01215.3.2010
11.3.2010Eporatioratiopharm GmbH Graf-Arco-Straße 3, D-89079 Ulm, DeutschlandEU/1/09/573/001-02815.3.2010
11.3.2010InovelonE isai Limited

E uropean Knowledge Centre, Mosquito Way, Hatfield, Herts, AL10 9SN, United Kingdom

EU/1/06/378/001-01615.3.2010
11.3.2010StelaraJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/08/494/003-00415.3.2010
11.3.2010ZopyaNorpharm Regulatory Services Ltd

26 Laurence Street, Drogheda, Co. Louth, Ireland

EU/1/09/562/001-00915.3.2010
15.3.2010AbraxaneAbraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United KingdomEU/1/07/428/00117.3.2010
15.3.2010AerinazeSP Europe

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

EU/1/07/399/001-00617.3.2010
15.3.2010AfinitorNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/538/001-00817.3.2010
15.3.2010AldaraMeda AB

Pipers väg 2A, Solna

170 73, Svërige

EU/1/98/080/00217.3.2010
15.3.2010AltargoGlaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/07/390/001-00417.3.2010
15.3.2010ArcalystRegeneron UK Limited 40 Bank Street, E14 5DS London, United KingdomEU/1/09/582/00117.3.2010
15.3.2010AtriplaBristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, IrelandEU/1/07/430/001-00219.3.2010
15.3.2010AvonexBiogen Idec Ltd Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United KingdomEU/1/97/033/002-00417.3.2010
15.3.2010BeneFIXWyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/97/047/001-00717.3.2010
15.3.2010BiopoinCT Arzneimittel GmbH Lengeder Straße 42a, D-13407 Berlin, DeutschlandEU/1/09/565/001-02817.3.2010
15.3.2010ByettaE li Lilly Nederland B.V. Grootslag 1-5, 3991 RA Houten, NederlandEU/1/06/362/001-00417.3.2010
15.3.2010CarbagluOrphan Europe

I mmeuble Le Wilson, 70

Avenue du General de

Gaulle, 92800 Puteaux,

France

EU/1/02/246/001-00317.3.2010
15.3.2010CaystonGilead Sciences Internation al Limited

Granta Park, Abington, Cambridge CB21 6GT, United Kingdom

EU/1/09/543/00117.3.2010
15.3.2010Clopidogrel DURAMylan dura GmbH Wittichstraße 6, D-64295 Darmstadt, DeutschlandEU/1/09/560/001-00917.3.2010
15.3.2010Clopidogrel HexalAcino Pharma GmbH Am Windfeld 35, Miesbach 83714, DeutschlandEU/1/09/534/001-00717.3.2010
15.3.2010Clopidogrel Teva PharmaTeva Pharma B.V. Computerweg 10, 3542 DR Utrecht, NederlandEU/1/09/561/001-01017.3.2010
15.3.2010CopaliaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/372/001-03617.3.2010
15.3.2010CubicinNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/05/328/001-00217.3.2010
15.3.2010DoribaxJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/08/467/001-00217.3.2010
15.3.2010Duloxetine Boehringer IngelheimBoehringer Ingelheim International GmbH Binger Strasse 173 - D -55216 Ingelheim am Rhein, DeutschlandEU/1/08/471/001-01217.3.2010
15.3.2010DynastatPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/1/02/209/001-00817.3.2010
15.3.2010EffentoraCephalon Europe 5 Rue Charles Martigny, Maisons-Alfort 94700, FranceEU/1/08/441/001-01022.3.2010
15.3.2010ElapraseShire Human Genetic Therapies AB

Svärdvägen 11D, 182 33 Danderyd, Sverige

EU/1/06/365/001-00317.3.2010
15.3.2010EucreasNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/425/001-01817.3.2010
15.3.2010EvoltraGenzyme Europe BV Gooimeer 10, 1411 DD Naarden, NederlandEU/1/06/334/001-00517.3.2010
15.3.2010ExjadeNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/356/001-00917.3.2010
15.3.2010FaslodexAstraZeneca UK Limited Alderley Park, Macclesfield, Cheshire, SK10 4TG United KingdomEU/1/03/269/00117.3.2010
15.3.2010FirazyrJerini AG

I nvalidenstr. 130, D-10115

Berlin, Deutschland

EU/1/08/461/00117.3.2010
15.3.2010GONAL-fMerck Serono Europe Ltd. 56, Marsh Wall, London E 14 9TP, United KingdomEU/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

17.3.2010
15.3.2010HumiraAbbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-01017.3.2010
15.3.2010IcandraNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/484/001-01823.3.2010
15.3.2010IntronASchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stal-lestraat, 73 - 1180 Brussel, BelgiëEU/1/99/127/011-04417.3.2010
15.3.2010InviraseRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/96/026/001-00217.3.2010
15.3.2010IscoverBristol-Myers Squibb Pharma EEIG

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

EU/1/98/070/01217.3.2010
15.3.2010KepivanceBiovitrum AB (publ) SE-112 76 Stockholm, SverigeEU/1/05/314/00117.3.2010
15.3.2010LuverisMerck Serono Europe Limited

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/00/155/001-00717.3.2010
15.3.2010MirceraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/07/400/001-02417.3.2010
15.3.2010M-M-RVAXPROSanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, FranceEU/1/06/337/001-01317.3.2010
15.3.2010MozobilGenzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, NederlandEU/1/09/537/00119.3.2010
15.3.2010NeuproSchwarz Pharma Ltd Shannon, Industrial Estate, Co. Clare, IrelandEU/1/05/331/001-05518.3.2010
15.3.2010NimvastidKRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/09/525/047-05017.3.2010
15.3.2010NorvirAbbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United KingdomEU/1/96/016/001

EU/1/96/016/003-004

17.3.2010
15.3.2010OvitrelleMerck Serono Europe Limited

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/00/165/001-00717.3.2010
15.3.2010PergoverisMerck Serono Europe Limited

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/07/396/001-00317.3.2010
15.3.2010PlavixSanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France -75013 Paris, FranceEU/1/98/069/01217.3.2010
15.3.2010PrezistaJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/06/380/001-00517.3.2010
15.3.2010RapamuneWyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/01/171/007-01017.3.2010
15.3.2010RemicadeCentocor B.V.

E in steinweg 101, 2333 CB

Leiden, Nederland

EU/1/99/116/001-00517.3.2010
15.3.2010RemovabFresenius Biotech GmbH Am Haag 6-7, D-82166 Graefelfing, DeutschlandEU/1/09/512/001-00217.3.2010
15.3.2010RevlimidCelgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United KingdomEU/1/07/391/001-00417.3.2010
15.3.2010ReyatazBristol-Myers Squibb Pharma EEIG

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

EU/1/03/267/001-01017.3.2010
15.3.2010SebivoNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/388/001-00317.3.2010
15.3.2010SebivoNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/388/001-00317.3.2010
15.3.2010StelaraJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/08/494/001-00217.3.2010
15.3.2010SutentPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/1/06/347/001-00817.3.2010
15.3.2010TamifluRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/02/222/001-00417.3.2010
15.3.2010Thalidomide CelgeneCelgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United KingdomEU/1/08/443/00117.3.2010
15.3.2010Twinrix AdultGlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/96/020/001-00917.3.2010
15.3.2010ValtropinBioPartners GmbH K aiserpassage 11 -D-72764 Reutlingen, DeutschlandEU/1/06/335/00117.3.2010
15.3.2010VaniqaLaboratorios Almirall, S.A. Ronda General Mitre, 151, 08022 Barcelona, EspañaEU/1/01/173/001-00317.3.2010
15.3.2010VantavoMerck Sharp & Dohme

Ltd.

Hertford Road, Hoddesdon,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/09/572/001-00917.3.2010
15.3.2010VectibixAmgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, NederlandEU/1/07/423/001-00317.3.2010
15.3.2010VireadGilead Sciences Internation al Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-00218.3.2010
15.3.2010ZomaristNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/483/001-01817.3.2010
15.3.2010ZylagrenKRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/09/558/001-01017.3.2010
19.3.2010Clopidogrel ratiopharm GmbHAcino Pharma GmbH Am Windfeld 35, 83714 Miesbach, DeutschlandEU/1/09/541/001-00823.3.2010
19.3.2010CopaliaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/372/001-03623.3.2010
19.3.2010DafiroNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/371/001-03623.3.2010
19.3.2010EvoltraGenzyme Europe BV Gooimeer 10, 1411 DD Naarden, NederlandEU/1/06/334/001-00523.3.2010
19.3.2010KineretBiovitrum AB (publ) SE-112 76, Stockholm, SverigeEU/1/02/203/001-00323.3.2010
19.3.2010RenvelaGenzyme Europe B.V. Gooimeer 10, 1411 DD Naarden, NederlandEU/1/09/521/001-00723.3.2010
19.3.2010VentavisBayer Schering Pharma AG Müllerstrasse 170-178, D -13342 Berlin, DeutschlandEU/1/03/255/001-00823.3.2010
22.3.2010FuzeonRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/03/252/001-00324.3.2010
23.3.2010AbilifyOtsuka Pharmaceutical E urope 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

25.3.2010
23.3.2010AeriusSchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, BelgiëEU/1/00/160/001-06925.3.2010
23.3.2010AloxiHelsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Republic of Ireland

EU/1/04/306/00125.3.2010
23.3.2010AranespAmgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, NederlandEU/1/01/185/001-022

EU/1/01/185/031-099

25.3.2010
23.3.2010AxuraMerz Pharmaceuticals

GmbH

E ckenheimer Landstr. 100,

D-60318 Frankfurt/Main -

Deutschland

EU/1/02/218/001-003

EU/1/02/218/007-010

EU/1/02/218/012-016

EU/1/02/218/023

25.3.2010
23.3.2010AzomyrSchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, BelgiëEU/1/00/157/001-06723.3.2010
23.3.2010CetrotideSE RONO EUROPE LIMITED

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/99/100/001-00325.3.2010
23.3.2010CholestagelGenzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, NederlandEU/1/03/268/001-00425.3.2010
23.3.2010Clopidogrel KrkaKRKA, d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/09/556/001-01125.3.2010
23.3.2010Clopidogrel ratiopharmAcino Pharma GmbH Am Windfeld 35, 83714 Miesbach, DeutschlandEU/1/09/554/001-00825.3.2010
23.3.2010Clopidogrel SandozAcino Pharma GmbH Am Windfeld 35, 83714 Miesbach, DeutschlandEU/1/09/547/001-00725.3.2010
23.3.2010Clopidogrel TADTAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, DeutschlandEU/1/09/555/001-00925.3.2010
23.3.2010Clopidogrel TevaTeva Pharma B.V. Computerweg 10, 3542 DR Utrecht, NederlandEU/1/09/540/001-01625.3.2010
23.3.2010Copalia HCTNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/575/001-06025.3.2010
23.3.2010Dafiro HCTNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/574/001-06025.3.2010
23.3.2010EnviageNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/406/001-02025.3.2010
23.3.2010ExelonNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/98/066/001-02625.3.2010
23.3.2010ExforgeNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/370/001-03625.3.2010
23.3.2010HumiraAbbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-01025.3.2010
23.3.2010IDfluSanofi Pasteur SA

2, avenue Pont Pasteur,

F-69007 Lyon, France

EU/1/08/507/001-00625.3.2010
23.3.2010ImpridaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/373/001-03625.3.2010
23.3.2010IxiaroIntercell AG

Campus Vienna Biocenter

3 A-1030 Wien, Österreich

EU/1/08/501/001-00225.3.2010
23.3.2010MabtheraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/98/067/001-00225.3.2010
23.3.2010Mycophenolate mofetil TevaTeva Pharma B.V. Computerweg 10, DR Utrecht 3542, NederlandEU/1/07/439/001-00425.3.2010
23.3.2010MyfenaxTeva Pharma B.V. Computerweg 10, DR Utrecht 3542, NederlandEU/1/07/438/001-00423.3.2010
23.3.2010NeoclaritynSchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, BelgiëEU/1/00/161/001-06723.3.2010
23.3.2010NorvirAbbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United KingdomEU/1/96/016/001

EU/1/96/016/003-006

25.3.2010
23.3.2010Oslif BreezhalerNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH-12 5AB, United Kingdom

EU/1/09/586/001-01025.3.2010
23.3.2010PrometaxNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/98/092/001-02625.3.2010
23.3.2010RevlimidCelgene Europe Limited Riverside House, Riverside Walk, Windsor, Berkshire SL4 1NA, United KingdomEU/1/07/391/001-00425.3.2010
23.3.2010RiprazoNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/409/001-02025.3.2010
23.3.2010SimponiCentocor B.V.

E in steinweg 101, 2333 CB

Leiden, Nederland

EU/1/09/546/001-00425.3.2010
23.3.2010SprimeoNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/407/001-02025.3.2010
23.3.2010StalevoOrion Corporation Orionintie 1, FIN-02200 Espoo, SuomiEU/1/03/260/001-03325.3.2010
23.3.2010SutentPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/1/06/347/001-00825.3.2010
23.3.2010SynagisAbbott Laboratories Ltd Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, United KingdomEU/1/99/117/001-00223.3.2010
23.3.2010TandemactTakeda Global Research an d Development Centre (Europe) Ltd. 61 Aldwich, London WC2B 4AE, United KingdomEU/1/06/366/005-02225.3.2010
23.3.2010TasignaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/422/001-00425.3.2010
23.3.2010Thalidomide CelgeneCelgene Europe Limited Riverside House, Riverside Walk, Windsor SL4 1NA, United KingdomEU/1/08/443/00125.3.2010
23.3.2010VisudyneNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/00/140/00125.3.2010
23.3.2010VolibrisGlaxo Group Ltd Greenford, Middlesex UB6 0NN, United KingdomEU/1/08/451/001-00425.3.2010
23.3.2010XelodaRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/00/163/001-00225.3.2010
26.3.2010AdcircaE li Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA, Houten, NederlandEU/1/08/476/005-00630.3.2010
26.3.2010AvandametSmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United KingdomEU/1/03/258/001-02230.3.2010
26.3.2010AvandiaSmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United KingdomEU/1/00/137/002-01830.3.2010
26.3.2010CelsentriPfizer Limited Ramsgate Road, Sandwich, K en t CT13 9NJ, United KingdomEU/1/07/418/001-01029.3.2010
26.3.2010CelsentriPfizer Limited Ramsgate Road, Sandwich, K en t CT13 9NJ, United KingdomEU/1/07/418/001-01029.3.2010
26.3.2010Clopidogrel QualimedQualimed

117, Allée des Parcs,

69 800 Saint Priest, France

EU/1/09/557/001-01030.3.2010
26.3.2010CompetactTakeda Global Research an d Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United KingdomEU/1/06/354/001-00930.3.2010
26.3.2010CubicinNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/05/328/001-00230.3.2010
26.3.2010EbixaH. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, DanmarkEU/1/02/219/001-003

EU/1/02/219/007-012

EU/1/02/219/014-022

EU/1/02/219/036

30.3.2010
26.3.2010Exforge HCTNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/569/001-06030.3.2010
26.3.2010GalvusNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/414/001-010

EU/1/07/414/018

30.3.2010
26.3.2010GlivecNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/01/198/001-01329.3.2010
26.3.2010GlivecNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/01/198/001-01329.3.2010
26.3.2010Helixate NexGenBayer Schering Pharma AG 13342 Berlin, DeutschlandEU/1/00/144/001-00430.3.2010
26.3.2010Hirobriz BreezhalerNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex, RH-12 5AB, United Kingdom

EU/1/09/594/001-01030.3.2010
26.3.2010IlarisNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/564/001-00230.3.2010
26.3.2010Imprida HCTNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/570/001-06030.3.2010
26.3.2010InductOsWyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/02/226/00130.3.2010
26.3.2010IntanzaSanofi Pasteur MSD SNC 8, rue Jonas Salk, Lyon 69007, FranceEU/1/08/505/001-00630.3.2010
26.3.2010IntronASchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, BelgiëEU/1/99/127/011-039

EU/1/99/127/041-044

30.3.2010
26.3.2010InvegaJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/07/395/001-09529.3.2010
26.3.2010InviraseRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/96/026/001-00230.3.2010
26.3.2010IsentressMerck Sharp & Dohme

Limited

Hertford Road, Hodderson,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/436/001-00230.3.2010
26.3.2010IvemendMerck Sharp & Dohme

Limited

Hertford Road, Hodderson,

Hertfordshire EN11 9BU,

United Kingdom

EU/1/07/437/00130.3.2010
26.3.2010JalraNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/485/001-01130.3.2010
26.3.2010Kogenate BayerBayer Schering Pharma AG 13342 Berlin, DeutschlandEU/1/00/143/001-01130.3.2010
26.3.2010Onbrez BreezhalerNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/593/001-01030.3.2010
26.3.2010PanretinE isai Limited

E uropean Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

EU/1/00/149/00130.3.2010
26.3.2010Rasilez HCTNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/491/001-08030.3.2010
26.3.2010RemicadeCentocor B.V.

E in steinweg 101, 2333 CB

Leiden, Nederland

EU/1/99/116/001-00530.3.2010
26.3.2010SustivaBristol-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

30.3.2010
26.3.2010TemomedacALFRED E. TIEFENBACHER, (GmbH & Co. KG) Van-der-Smissen-Straße 1, Hamburg 22767, DeutschlandEU/1/09/605/001-01230.3.2010
26.3.2010TygacilWyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/06/336/00129.3.2010
26.3.2010VistideGilead Sciences Internation al Limited

Cambridge, CB21 6GT, United Kingdom

EU/1/97/037/00130.3.2010
26.3.2010XagridShire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/00129.3.2010
26.3.2010XiliarxNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/486/001-01130.3.2010
30.3.2010AclastaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/05/308/001-0021.4.2010
30.3.2010ActosTakeda Global Research an d Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United KingdomEU/1/00/150/001-0241.4.2010
30.3.2010AfinitorNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/538/001-0081.4.2010
30.3.2010CelvapanBaxter AG

Industriestraße 67, A -1221 Wien, Österreich

EU/1/08/506/0011.4.2010
30.3.2010Clopidogrel MylanMylan S.A.S

117 allée des Parcs,

69 800 Saint Priest, France

EU/1/09/559/001-0161.4.2010
30.3.2010EvicelOMRIX biopharmaceuticals S.A. / N.V.

200 Chaussée de Waterloo / Waterloosesteenweg 200, B-1640 Rhode-St-Genèse / B-1640 Sint-Genesius-Rode, Belgique / België

EU/1/08/473/001-0031.4.2010
30.3.2010ExtaviaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/454/001-002

EU/1/08/454/005-007

1.4.2010
30.3.2010GlubravaTakeda Global Research an d Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United KingdomEU/1/07/421/001-0091.4.2010
30.3.2010GlustinTakeda Global Research an d Development Centre (Europe) Ltd 61 Aldwych, London WC2B 4AE, United KingdomEU/1/00/151/001-0241.4.2010
30.3.2010IncrelexIpsen Pharma 65, quai Georges Gorse, 92100 Boulogne-Billancourt, FranceEU/1/07/402/0011.4.2010
30.3.2010IntelenceJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/08/468/0011.4.2010
30.3.2010KaletraAbbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/01/172/004-00731.3.2010
30.3.2010LevemirNovo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, DanmarkEU/1/04/278/010-0116.4.2010
30.3.2010LucentisNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/06/374/0011.4.2010
30.3.2010RasilezNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/405/001-04031.3.2010
30.3.2010RoActemraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/08/492/001-0061.4.2010
30.3.2010RotarixGlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/05/330/001-0111.4.2010
30.3.2010RotaTeqSanofi Pasteur MSD, SNC 8, rue Jonas Salk, Lyon 69007, FranceEU/1/06/348/001-0021.4.2010
30.3.2010XolairNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/05/319/001-01031.3.2010
6.4.2010RetacritHOSPIRA Enterprises B.V. Taurusavenue 19-21, 2132 LS HOOFDDORP, NederlandEU/1/07/431/001-02514.4.2010
6.4.2010SilapoSTADA Arzneimittel AG Stadastrasse 2-18, 61118 Bad Vilbel, DeutschlandEU/1/07/432/001-0229.4.2010
9.4.2010AvaglimSmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United KingdomEU/1/06/349/001-01013.4.2010
9.4.2010KetekAventis Pharma S.A.

20 avenue Raymond Aron,

F-92160 Antony, France

EU/1/01/191/001-00513.4.2010
9.4.2010VireadGilead Sciences Internation al Limited

Cambridge CB21 6GT United Kingdom

EU/1/01/200/001-00213.4.2010
15.4.2010FirdapseEUSA Pharma SAS 3 Allée des Séquoias, Limonest 69760, FRANCEEU/1/09/601/00120.4.2010
19.4.2010IfirmastaKRKA, d.d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, SlovenijaEU/1/08/480/001-01823.4.2010
22.4.2010Sildenafil TevaTeva Pharma B.V. Computerweg 10, 3542 DR Utrecht, NederlandEU/1/09/584/001-01826.4.2010
22.4.2010TracleerActelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United KingdomEU/1/02/220/001-00626.4.2010
27.4.2010AfinitorNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/09/538/001-00829.4.2010
27.4.2010AldaraMeda AB

Pipers väg 2A, Solna

170 73, Svërige

EU/1/98/080/001-00229.4.2010
27.4.2010AldurazymeGenzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, NederlandEU/1/03/253/001-00329.4.2010
27.4.2010AltargoGlaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/07/390/001-00429.4.2010
27.4.2010BridionN.V. Organon

K loosterstraat 6, 5349 AB

Oss, Nederland

EU/1/08/466/001-00229.4.2010
27.4.2010DoribaxJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/08/467/001-00229.4.2010
27.4.2010ExelonNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/98/066/001-02629.4.2010
27.4.2010FocetriaNovartis Vaccines and

Diagnostics S.r.l.

Via Fiorentina, 1 - Siena,

Italia

EU/1/07/385/001-002

EU/1/07/385/004

29.4.2010
27.4.2010FuzeonRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/03/252/001-00329.4.2010
27.4.2010KinzalkombBayer Schering Pharma AG D-13342 Berlin, DeutschlandEU/1/02/214/001-01529.4.2010
27.4.2010MicardisPlusBoehringer Ingelheim International GmbH Binger Strasse 173- D -55216 Ingelheim am Rhein, DeutschlandEU/1/02/213/001-0233.5.2010
27.4.2010RemicadeCentocor B.V.

E in steinweg 101, 2333 CB

Leiden, Nederland

EU/1/99/116/001-00529.4.2010
27.4.2010RoActemraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/08/492/001-00629.4.2010
27.4.2010TamifluRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/02/222/001-00429.4.2010
27.4.2010TarcevaRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/05/311/001-00329.4.2010
27.4.2010TaxotereAventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, FranceEU/1/95/002/001-00529.4.2010
27.4.2010TyverbGlaxo Group Limited Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/07/440/001-00229.4.2010
27.4.2010VelcadeJanssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-00229.4.2010
27.4.2010VimpatUCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, BelgiëEU/1/08/470/014-01529.4.2010
29.4.2010AclastaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/05/308/001-0023.5.2010
29.4.2010AravaSanofi-Aventis Deutschland

GmbH

D-65926 Frankfurt am

Main, Deutschland

EU/1/99/118/001-0103.5.2010
29.4.2010CepleneEpiCept GmbH Goethestrasse 4, D-80336 München, DeutschlandEU/1/08/477/0013.5.2010
29.4.2010Clopidogrel WinthropSanofi-Aventis

174, avenue de France,

F-75013 Paris, France

EU/1/08/465/001-0203.5.2010
29.4.2010EpivirGlaxo Group Ltd. Greenford Road, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/96/015/001-0054.5.2010
29.4.2010FocetriaNovartis Vaccines and

Diagnostics S.r.l.

Via Fiorentina, 1 - Siena,

Italia

EU/1/07/385/001-002

EU/1/07/385/004

3.5.2010
29.4.2010HumiraAbbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-0104.5.2010
29.4.2010InsulatardNovo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, DanmarkEU/1/02/233/001-0173.5.2010
29.4.2010IntelenceJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/08/468/0013.5.2010
29.4.2010IscoverBristol-Myers Squibb Pharma EEIG

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

EU/1/98/070/001a-001b

EU/1/98/070/002a-002b

EU/1/98/070/003a-003b

EU/1/98/070/004a-004b

EU/1/98/070/005a-005b

EU/1/98/070/006a-006b

EU/1/98/070/007a-007b

EU/1/98/070/008-010

EU/1/98/070/011a-011b

EU/1/98/070/012

4.5.2010
29.4.2010KepivanceBiovitrum AB (publ) SE-112 76 Stockholm, SverigeEU/1/05/314/0013.5.2010
29.4.2010LyricaPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/1/04/279/001-0434.5.2010
29.4.2010MirceraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/07/400/001-0244.5.2010
29.4.2010NeoRecormonRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/97/031/019-0464.5.2010
29.4.2010PlavixSanofi Pharma Bristol-Myers Squibb SNC 174 avenue de France -75013 Paris, FranceEU/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

3.5.2010
29.4.2010PritorPlusBayer Schering Pharma AG 13342 Berlin, DeutschlandEU/1/02/215/001-0213.5.2010
29.4.2010PrometaxNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/98/092/001-0264.5.2010
29.4.2010ProtaphaneNovo Nordisk A/S Novo Allé, DK-2880 Bags-vaerd, DanmarkEU/1/02/234/001-0173.5.2010
29.4.2010TygacilWyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/06/336/0013.5.2010
29.4.2010TyverbGlaxo Group Limited Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/07/440/001-0023.5.2010
29.4.2010VectibixAmgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, NederlandEU/1/07/423/001-0033.5.2010
5.5.2010AloxiHelsinn Birex Pharmaceuticals Ltd

Damastown, Mulhuddart, Dublin 15, Republic of Ireland

EU/1/04/306/001-0037.5.2010
5.5.2010BeneFIXWyeth Europa Ltd. Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/97/047/001-0077.5.2010
5.5.2010BondenzaRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/03/266/003-0067.5.2010
5.5.2010BonvivaRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/03/265/003-0067.5.2010
5.5.2010CelsentriPfizer Limited Ramsgate Road, Sandwich, K en t CT13 9NJ, United KingdomEU/1/07/418/001-0107.5.2010
5.5.2010Docetaxel WinthropAventis Pharma S.A. 20 avenue Raymond Aron, F-92165 Antony Cedex, FranceEU/1/07/384/001-0057.5.2010
5.5.2010EnbrelWyeth Europa Limited Huntercombe Lane South, Taplow, Maidenhead, Berkshire, SL6 0PH, United KingdomEU/1/99/126/001-0217.5.2010
5.5.2010KiovigBaxter AG

Industriestraße 67, A -1221 Wien, Österreich

EU/1/05/329/001-0067.5.2010
5.5.2010LantusSanofi-Aventis Deutschland

GmbH

D-65926 Frankfurt am

Main, Deutschland

EU/1/00/134/001-0377.5.2010
5.5.2010OptisulinSanofi-Aventis Deutschland

GmbH

D-65926 Frankfurt am

Main, Deutschland

EU/1/00/133/001-0327.5.2010
5.5.2010PegIntronSchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, BelgiëEU/1/00/131/001-0507.5.2010
5.5.2010SilgardMerck Sharp & Dohme Ltd Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United KingdomEU/1/06/358/001-0217.5.2010
5.5.2010SprycelBristol-Myers Squibb Pharma EEIG

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

EU/1/06/363/001-0117.5.2010
5.5.2010TyverbGlaxo Group Limited Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/07/440/001-0037.5.2010
5.5.2010ViraferonPegSchering Plough Europe Rue de Stalle, 73, 1180 Bruxelles, Belgique - Stallestraat, 73 - 1180 Brussel, BelgiëEU/1/00/132/001-0507.5.2010
5.5.2010VisudyneNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/00/140/0017.5.2010
10.5.2010AtriplaBristol-Myers Squibb and Gilead Sciences Limited IDA Business & Technology Park, Carrigtohill, Co. Cork, IrelandEU/1/07/430/001-00212.5.2010
10.5.2010CombivirGlaxo Group Ltd. Greenford Road, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/98/058/001-00212.5.2010
10.5.2010Infanrix hexaGlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, Rixensart, B-1330 Belgique

EU/1/00/152/001-02012.5.2010
10.5.2010OptimarkCovidien Deutschland GmbH

Gewerbepark 1, Neustadt/Donau 93333, Deutschland

EU/1/07/398/001-01412.5.2010
10.5.2010OrgalutranN.V. Organon P.O. Box 20, Kloosterstraat 6, 5340 BH Oss, NederlandEU/1/00/130/001-00212.5.2010
10.5.2010RanexaMenarini International Operations Luxembourg S.A.

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

EU/1/08/462/001-01212.5.2010
10.5.2010TysabriElan Pharma International Ltd.

Monksland, Athlone, County Westmeath, Ireland

EU/1/06/346/00112.5.2010
10.5.2010XeristarBoehringer Ingelheim International GmbH Binger Strasse 173- D -55216 Ingelheim am Rhein, DeutschlandEU/1/04/297/001-00812.5.2010
10.5.2010ZiagenGlaxo Group Ltd. Greenford Road, Green-ford, Middlesex UB6 0NN United KingdomEU/1/99/112/001-00212.5.2010
12.5.2010AclastaNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/05/308/001-00218.5.2010
12.5.2010GardasilSanofi Pasteur MSD, SNC 8, rue Jonas Salk, 69007 Lyon, FranceEU/1/06/357/001-02118.5.2010
12.5.2010KuvanMerck KGaA Frankfurter Straße 250, 64293 Darmstadt, DeutschlandEU/1/08/481/001-00318.5.2010
12.5.2010OlazaxGlenmark Pharmaceuticals

s.r.o.

City Tower, Hvězdova

1716/2b, 140 78 Praha 4,

Česká republika

EU/1/09/597/001-00518.5.2010
26.5.2010AvandiaSmithKline Beecham Ltd. 980 Great West Road, Brentford, Middlesex, TW8 9GS United KingdomEU/1/00/137/002-01828.5.2010
26.5.2010CyanokitMerck Santé s.a.s. 37, rue Saint-Romain, 69379 Lyon Cedex 08, FranceEU/1/07/420/00128.5.2010
26.5.2010KivexaGlaxo Group Ltd Greenford, Middlesex UB6 0NN, United KingdomEU/1/04/298/001-00328.5.2010
26.5.2010MyocetCephalon Europe 5 Rue Charles Martigny, Maisons Alfort 94700, FranceEU/1/00/141/00128.5.2010
26.5.2010Olanzapine GlenmarkGlenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/587/001-0171.6.2010
26.5.2010Olanzapine Glenmark EuropeGlenmark Generics (Europe) Limited

Laxmi House, 2-B Draycott Avenue, Kenton, Harrow, Middlesex HA3 OBU, United Kingdom

EU/1/09/588/001-0121.6.2010
26.5.2010Olazax DisperziGlenmark Pharmaceuticals

s.r.o.

City Tower, Hvězdova

1716/2b, 140 78 Praha 4,

Česká republika

EU/1/09/592/001-00528.5.2010
26.5.2010PrevenarWyeth-Lederle Vaccines S.A.

Rue du Bosquet, 15 - 1348 Louvain-La-Neuve, Belgique

EU/1/00/167/001-00828.5.2010
26.5.2010TelzirGlaxo Group Ltd. Greenford Road, Green-ford, Middlesex UB6 0NN United KingdomEU/1/04/282/001-00228.5.2010
26.5.2010TrizivirGlaxo Group Ltd. Greenford Road, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/00/156/002-00428.5.2010
26.5.2010XagridShire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295/00128.5.2010
2.6.2010AbraxaneAbraxis BioScience Limited Rosanne House, Parkway, Welwyn Garden City, Herts, AL8 6HG, United KingdomEU/1/07/428/0014.6.2010
2.6.2010AvastinRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/04/300/001-0027.6.2010
2.6.2010BridionN.V. Organon

K loosterstraat 6, 5349 AB

Oss, Nederland

EU/1/08/466/001-0024.6.2010
2.6.2010CelsentriPfizer Limited Ramsgate Road, Sandwich, K en t CT13 9NJ, United KingdomEU/1/07/418/001-0104.6.2010
2.6.2010CervarixGlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419/001-0124.6.2010
2.6.2010CircadinRAD Neurim Pharmaceuticals EEC Limited One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United KingdomEU/1/07/392/001-0027.6.2010
2.6.2010ErbituxMerck KGaA Frankfurter Straße 250, 64271 Darmstadt, DeutschlandEU/1/04/281/001-0057.6.2010
2.6.2010FertavidSP Europe

Rue de Stalle, 73 B-1180

Bruxelles, Belgique

EU/1/09/510/001-0194.6.2010
2.6.2010HumiraAbbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL 6 4XE, United Kingdom

EU/1/03/256/001-0107.6.2010
2.6.2010IntrinsaWarner Chilcott Pharmaceuticals UK Ltd Whitehall Lane, Egham, Surrey TW20 9NW, United KingdomEU/1/06/352/001-0034.6.2010
2.6.2010PrezistaJanssen-Cilag International

NV

Turnhoutseweg, 30 - 2340

Beerse - België

EU/1/06/380/001-0054.6.2010
2.6.2010RasilezNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/07/405/001-0404.6.2010
2.6.2010RebifMerck Serono Europe Limited

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/98/063/001-0174.6.2010
2.6.2010RenagelGenzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, NederlandEU/1/99/123/005-0137.6.2010
2.6.2010StalevoOrion Corporation Orionintie 1, FIN-02200 Espoo, SuomiEU/1/03/260/001-0334.6.2010
2.6.2010VelcadeJanssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/04/274/001-0024.6.2010
2.6.2010VimpatUCB Pharma SA. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef, 60, Brussel 1070, BelgiëEU/1/08/470/001-0177.6.2010
2.6.2010ZavescaActelion Registration Ltd BSI Building 13th Floor, 389 Chiswick High Road, London W4 4AL, United KingdomEU/1/02/238/0014.6.2010
4.6.2010DepoCytePacira Limited West Forest Gate, Wellington Road, Wokingham, Berkshire, RG40 2AQ, United KingdomEU/1/01/187/0018.6.2010
4.6.2010MetalyseBoehringer Ingelheim International GmbH Binger Strasse 173- D -55216 Ingelheim am Rhein, DeutschlandEU/1/00/169/004-0068.6.2010
4.6.2010MirceraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/07/400/001-0248.6.2010
4.6.2010NymusaCHIESI FARMACEUTICI

SpA

Via Palermo 26/A, I-43100

Parma, ITALIA

EU/1/09/528/001-0028.6.2010
4.6.2010Rasilez HCTNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/08/491/001-0808.6.2010
4.6.2010RoActemraRoche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United KingdomEU/1/08/492/001-0068.6.2010
4.6.2010ToviazPfizer Limited Ramsgate Road, Sandwich, K en t CT13 9NJ, United KingdomEU/1/07/386/001-0188.6.2010
4.6.2010ZeritBristol-Myers Squibb Pharma EEIG

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

EU/1/96/009/001-0098.6.2010
8.6.2010LyricaPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/1/04/279/001-04410.6.2010
10.6.2010ComtanNovartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH-12 5AB, United Kingdom

EU/1/98/081/001-00414.6.2010
10.6.2010ComtessOrion Corporation Orionintie 1, FIN-02200 Espoo, SuomiEU/1/98/082/001-003

EU/1/98/082/005

14.6.2010
10.6.2010ellaOneLaboratoire HRA Pharma 15, rue Béranger, 75003 Paris, FranceEU/1/09/522/00114.6.2010
10.6.2010MirapexinBoehringer Ingelheim International GmbH Binger Strasse 173- D -55216 Ingelheim am Rhein, DeutschlandEU/1/97/051/001-006

EU/1/97/051/009-033

15.6.2010
10.6.2010OpgenraHowmedica International S. de R. L.

Raheen Business Park, Limerick, Ireland

EU/1/08/489/001-00215.6.2010
10.6.2010PergoverisMerck Serono Europe Limited

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/07/396/001-00314.6.2010
10.6.2010VasovistTMC Pharma Services Ltd Eversley, Hampshire, RG-27 0NT, United KingdomEU/1/05/313/001-00914.6.2010
14.6.2010LyricaPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/1/04/279/001-04416.6.2010
14.6.2010SifrolBoehringer Ingelheim International GmbH Binger Strasse 173, D-55216 Ingelheim am Rhein, DeutschlandEU/1/97/050/001-006 EU/1/97/050/009-03317.6.2010
17.6.2010ATrynGTC Biotherapeutics UK Limited

10 Norwich Street, London E C4A 1BD, United Kingdom

EU/1/06/355/001-00321.6.2010
17.6.2010LuverisMerck Serono Europe Limited

56, Marsh Wall, London E 14 9TP, United Kingdom

EU/1/00/155/001-00721.6.2010
17.6.2010MirapexinBoehringer Ingelheim International GmbH Binger Strasse 173- D -55216 Ingelheim am Rhein, DeutschlandEU/1/97/051/001-006

EU/1/97/051/009-033

21.6.2010
17.6.2010OnsenalPfizer Limited Ramsgate Road, Sandwich, K en t CT13 9NJ, United KingdomEU/1/03/259/001-00621.6.2010
17.6.2010TyverbGlaxo Group Limited Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/07/440/001-00321.6.2010

– Wycofanie pozwolenia na dopuszczenie do obrotu (art. 13 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady)

Data wydania decyzjiNazwa produktu leczniczegoPosiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymData notyfikacji
29.4.2010AgeneraseGlaxo Group Limited Glaxo Wellcome House, Berkeley Avenue, Green-ford, Middlesex UB6 0NN, United KingdomEU/1/00/148/001-0045.5.2010
26.5.2010Duloxetine Boehringer IngelheimBoehringer Ingelheim International GmbH Binger Strasse 173 - D -55216 Ingelheim am Rhein, DeutschlandEU/1/08/471/003-005

EU/1/08/471/011-012

28.5.2010

– Zmiana pozwolenia na dopuszczenie do obrotu (art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady): Zatwierdzenie

Data wydania decyzjiNazwa produktu leczniczegoPosiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymData notyfikacji
15.3.2010AivlosinE CO Animal Health Ltd 78 Coombe Road New Malden Surrey KT3 4QS United KingdomEU/2/04/044/001-00217.3.2010
15.3.2010DraxxinPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/2/03/041/00417.3.2010
15.3.2010IncurinIntervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, NederlandEU/2/00/018/00117.3.2010
15.3.2010MasivetAB Science S.A.

3 avenue George V, 75008

Paris, France

EU/2/08/087/001-00217.3.2010
15.3.2010MeloxivetJanssen Pharmaceutica N.V. Turnhoutseweg 30, B-2340 Beerse, BelgiëEU/2/07/077/001-00517.3.2010
15.3.2010SevoFloAbbott Laboratories Limited

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4XE, UNITED KINGDOM

EU/2/02/035/00717.3.2010
16.3.2010Rabigen SAG2VIRBAC S.A.

1ère Avenue 2065 m L.I.D.

- 06516 Carros - France

EU/2/00/021/001-00219.3.2010
22.3.2010Purevax FeLVMerial

29 Avenue Tony Garnier,

69007 Lyon, France

EU/2/00/019/005-00724.3.2010
23.3.2010IbraxionMerial

29 Avenue Tony Garnier,

69007 Lyon, France

EU/2/99/017/001-00623.3.2010
23.3.2010LoxicomNorbrook Laboratories

Limited

Station Works, Newry, Co.

Down, BT35 6JP, United

Kindgom

EU/2/08/090/001-00925.3.2010
26.3.2010MeloxidylCEVA SANTE ANIMALE 10 avenue de la Ballastière, 33500 Libourne, FranceEU/2/06/070/001-00730.3.2010
30.3.2010ActicamOmnipharm Ltd Suite 3, 24 High Street, Ruddington, Nottingham, NG11 6EA, United KingdomEU/2/08/088/001-0041.4.2010
9.4.2010SlentrolPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/2/07/071/001-00313.4.2010
27.4.2010Vaxxitek HVT+ IBDMerial

29 Avenue Tony Garnier,

69007 Lyon, France

EU/2/02/032/001-00229.4.2010
29.4.2010TrocoxilPfizer Limited Ramsgate Road, Sandwich, K en t, CT13 9NJ United KingdomEU/2/08/084/001-0054.5.2010
26.5.2010IbaflinIntervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, NederlandEU/2/00/022/001a-001b

EU/2/00/022/002a-002b

EU/2/00/022/003a-003b

EU/2/00/022/004a-004b

EU/2/00/022/005-017

28.5.2010
26.5.2010NaxcelPfizer Ltd

Ramsgate Road, Sandwich,

K en t CT 13 9NJ, United

Kingdom

EU/2/05/053/001-00328.5.2010
2.6.2010MetacamBoehringer Ingelheim Vet-medica GmbH 55216 Ingelheim am Rhein, DeutschlandEU/2/97/004/026

EU/2/97/004/033-034

4.6.2010
10.6.2010FlexicamDechra Veterinary Products

A/S

Mekuvej 9, 7171 Uldum,

Danmark

EU/2/06/058/001-00414.6.2010

– Wycofanie pozwolenia na dopuszczenie do obrotu (art. 38 rozporządzenia (WE) nr 726/2004 Parlamentu Europejskiego i Rady)

Data wydania decyzjiNazwa produktu leczniczegoPosiadacz pozwolenia na dopuszczenie do obrotuNumer pozycji w rejestrze wspólnotowymData notyfikacji
14.6.2010PrubanIntervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, NederlandEU/2/00/024/00116.6.2010

Osoby zainteresowane dostępem do publicznego sprawozdania oceniającego dla danego produktu leczniczego oraz do związanych z nim decyzji prosimy o kontakt z:

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK - LONDON E14 4H

______

(1) Dz.U. L 136 z 30.4.2004, s. 1.

© Unia Europejska, http://eur-lex.europa.eu/
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