Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-01-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014029EN.01000101.xml










31.1.2014   


EN


Official Journal of the European Union


C 29/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2013 to 31 December 2013

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

2014/C 29/01
—   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




4.12.2013


Fluenz Tetra


Influenza Virus Type A, H1N1 / Influenza Virus Type A, H3N2 / Influenza Virus Type B (Victoria lineage) / Influenza Virus, Type B (Yamagata lineage)







MedImmune, LLC




Lagelandseweg 78,




NL-6545 CG Nijmegen,




Nederland






EU/1/13/887


Nasal spray, suspension


J07BB03


6.12.2013




4.12.2013


Memantine Accord


memantine







Accord Healthcare Limited




Sage House,




319 Pinner Road, North Harrow,




Middlesex,




HA1 4HF,




United Kingdom






EU/1/13/880


Film-coated tablet


N06DX01


6.12.2013




18.12.2013


Brintellix


vortioxetine







H. Lundbeck A/S




Ottiliavej 9,




DK-2500 Valby,




Danmark






EU/1/13/891


Film-coated tablet
Oral drops, solution


N06AX26


20.12.2013




20.12.2013


Opsumit


macitentan







Actelion Registration Ltd




Cheswick Tower, 13th floor,




389 Cheswick High Road,




London




W4 4AL,




United Kingdom






EU/1/13/893


Film-coated tablet


C02KX04


27.12.2013







—   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




3.12.2013


Abraxane







Celgene Europe Limited




1 Longwalk Road, Stockley Park,




Uxbridge




UB11 1DB,




United Kingdom






EU/1/07/428


6.12.2013




3.12.2013


Bondronat







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/96/012


6.12.2013




3.12.2013


Cubicin







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/05/328


6.12.2013




3.12.2013


Dynastat







Pfizer Limited




Ramsgate Road, Sandwich, Kent




CT13 9NJ,




United Kingdom






EU/1/02/209


6.12.2013




3.12.2013


Orencia







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge




UB8 1DH,




United Kingdom






EU/1/07/389


6.12.2013




3.12.2013


Rasilamlo







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/11/686


6.12.2013




3.12.2013


Rasilez







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/07/405


6.12.2013




3.12.2013


Rasilez HCT







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/08/491


6.12.2013




3.12.2013


Xeplion







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/672


6.12.2013




3.12.2013


Zoledronic acid medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstr. 6,




D-22880 Wedel,




Deutschland






EU/1/12/779


6.12.2013




4.12.2013


Synagis







AbbVie Ltd




Maidenhead,




SL6 4XE,




United Kingdom






EU/1/99/117


6.12.2013




4.12.2013


Tamiflu







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/02/222


6.12.2013




9.12.2013


Sildenafil ratiopharm







ratiopharm GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/09/603


11.12.2013




13.12.2013


Dificlir







Astellas Pharma Europe B.V.




Sylviusweg 62,




NL-2333 BE Leiden,




Nederland






EU/1/11/733


16.12.2013




13.12.2013


Inovelon







Eisai Limited




European Knowledge Centre, Mosquito Way, Hatfield, Herts




AL10 9SN,




United Kingdom






EU/1/06/378


17.12.2013




13.12.2013


Irbesartan / Hydrochlorothiazide Teva







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/09/583


18.12.2013




13.12.2013


JEVTANA







Sanofi-Aventis groupe




54 rue La Boétie,




F-75008 Paris,




France






EU/1/11/676


17.12.2013




13.12.2013


Mimpara







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/04/292


17.12.2013




13.12.2013


Revatio







Pfizer Limited




Ramsgate Road, Sandwich, Kent




CT13 9NJ,




United Kingdom






EU/1/05/318


17.12.2013




13.12.2013


Temozolomide HEXAL







Hexal AG




Industriestrasse 25,




D-83607 Holzkirchen,




Deutschland






EU/1/10/616


17.12.2013




13.12.2013


Tracleer







Actelion Registration Ltd




Cheswick Tower, 13th floor, 389 Cheswick High Road,




London




W4 4AL,




United Kingdom






EU/1/02/220


17.12.2013




17.12.2013


Benlysta







Glaxo Group Ltd




980 Great West Road, Brentford, Middlesex,




TW8 9GS,




United Kingdom






EU/1/11/700


19.12.2013




17.12.2013


Esbriet







InterMune UK Limited




Grove House, 2nd Floor, 248A Marylebone Road,




London




NW1 6JZ,




United Kingdom






EU/1/11/667


19.12.2013




17.12.2013


Glybera







uniQure biopharma B.V.




Meibergdreef 61,




NL-1105 BA Amsterdam,




Nederland






EU/1/12/791


19.12.2013




17.12.2013


Isentress







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/436


19.12.2013




17.12.2013


Ovitrelle







Merck Serono Europe Limited




56, Marsh Wall,




London




E14 9TP,




United Kingdom






EU/1/00/165


20.12.2013




18.12.2013


Actraphane







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/229


20.12.2013




18.12.2013


Actrapid







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/230


20.12.2013




18.12.2013


Aflunov







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/658


20.12.2013




18.12.2013


Aldurazyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/03/253


23.12.2013




18.12.2013


APTIVUS







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/05/315


2.1.2014




18.12.2013


Bonviva







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/03/265


20.12.2013




18.12.2013


Bronchitol







Pharmaxis Pharmaceuticals Limited




The Priory, Stomp Road, Burnham, Buckinghamshire




SL1 7LW,




United Kingdom






EU/1/12/760


23.12.2013




18.12.2013


Buccolam







ViroPharma SPRL-BVBA rue Montoyer 47,




1000 Bruxelles, Belgique / Montoyerstraat 47,




1000 Brussel,




België






EU/1/11/709


19.12.2013




18.12.2013


Cervarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/07/419


23.12.2013




18.12.2013


Corlentor







Les Laboratoires Servier




50 rue Carnot,




F-92284 Suresnes CEDEX,




France






EU/1/05/317


23.12.2013




18.12.2013


Dexdor







Orion Corporation




Orionintie 1,




FI-02200




Espoo,




Suomi






EU/1/11/718


23.12.2013




18.12.2013


Efient







Eli Lilly Nederland B.V.




Grootslag 1-5,




NL-3991 RA Houten,




Nederland






EU/1/08/503


23.12.2013




18.12.2013


Emend







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/03/262


20.12.2013




18.12.2013


Eporatio







ratiopharm GmbH




Graf-Arco-Straße 3,




D-89079 Ulm,




Deutschland






EU/1/09/573


20.12.2013




18.12.2013


Erbitux







Merck KGaA




64271 Darmstadt






EU/1/04/281


23.12.2013




18.12.2013


Esmya







Gedeon Richter Plc.




Gyömrői út 19-21.,




H-1103 Budapest,




Magyarország






EU/1/12/750


23.12.2013




18.12.2013


Extavia







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/08/454


20.12.2013




18.12.2013


Faslodex







AstraZeneca UK Limited




Alderley Park, Macclesfield, Cheshire,




SK10 4TG




United Kingdom






EU/1/03/269


23.12.2013




18.12.2013


GILENYA







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/11/677


23.12.2013




18.12.2013


Herceptin







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/00/145


23.12.2013




18.12.2013


Hizentra







CSL Behring GmbH




Emil-von-Behring-Straße 76,




D-35041




Marburg,




Deutschland






EU/1/11/687


23.12.2013




18.12.2013


Incivo







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/11/720


20.12.2013




18.12.2013


Kaletra







AbbVie Ltd




Maidenhead,




SL6 4XE,




United Kingdom






EU/1/01/172


23.12.2013




18.12.2013


Levetiracetam SUN







Sun Pharmaceutical Industries Europe BV




Polarisavenue 87,




NL-2132 JH




Hoofddorp,




Nederland






EU/1/11/741


23.12.2013




18.12.2013


Lojuxta







Aegerion Pharmaceuticals Limited




Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge




UB11 1BD,




United Kingdom






EU/1/13/851


23.12.2013




18.12.2013


Luveris







Merck Serono Europe Limited




56, Marsh Wall,




London




E14 9TP,




United Kingdom






EU/1/00/155


23.12.2013




18.12.2013


Mepact







Takeda France SAS




Immeuble Pacific,




11-13 cours Valmy,




92800 Puteaux,




France






EU/1/08/502


23.12.2013




18.12.2013


Myozyme







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/06/333


23.12.2013




18.12.2013


Nivestim







Hospira UK Limited




Queensway, Royal Leamington Spa, Warwickshire




CV31 3RW,




United Kingdom






EU/1/10/631


20.12.2013




18.12.2013


Norvir







AbbVie Ltd




Maidenhead,




SL6 4XE,




United Kingdom






EU/1/96/016


20.12.2013




18.12.2013


NovoSeven







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/96/006


23.12.2013




18.12.2013


Pradaxa







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/08/442


2.1.2014




18.12.2013


Procoralan







Les Laboratoires Servier




50 rue Carnot,




F-92284 Suresnes CEDEX,




France






EU/1/05/316


23.12.2013




18.12.2013


ProQuad







Sanofi Pasteur MSD, SNC




8 rue Jonas Salk,




F-69007 Lyon,




France






EU/1/05/323


20.12.2013




18.12.2013


Protopic







Astellas Pharma Europe B.V.




Sylviusweg 62,




NL-2333 BE Leiden,




Nederland






EU/1/02/201


23.12.2013




18.12.2013


Removab







Fresenius Biotech GmbH




Am Haag 6-7,




D-82166 Graefelfing,




Deutschland






EU/1/09/512


20.12.2013




18.12.2013


Repaglinide Teva







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/09/530


24.12.2013




18.12.2013


Ribavirin Mylan







Generics [UK] Limited




Station Close, Potters Bar, Hertfordshire,




EN6 1TL,




United Kingdom






EU/1/10/634


20.12.2013




18.12.2013


Soliris







Alexion Europe SAS




25 boulevard de l'Amiral Bruix,




F-75016 Paris,




France






EU/1/07/393


23.12.2013




18.12.2013


Temodal







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/98/096


23.12.2013




18.12.2013


VELCADE







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/04/274


23.12.2013




18.12.2013


Xeloda







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/00/163


23.12.2013




18.12.2013


Xgeva







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/11/703


23.12.2013




18.12.2013


Yervoy







Bristol-Myers Squibb Pharma EEIG




Uxbridge Business Park, Sanderson Road, Uxbridge




UB8 1DH,




United Kingdom






EU/1/11/698


23.12.2013




18.12.2013


Yondelis







Pharma Mar S.A.




Polígono Industrial La Mina,




Avda de los Reyes 1,




E-28770 Colmenar Viejo, Madrid,




España






EU/1/07/417


23.12.2013




18.12.2013


Zelboraf







Roche Registration Limited




6 Falcon Way, Shire Park, Welwyn Garden City,




AL7 1TW,




United Kingdom






EU/1/12/751


23.12.2013




20.12.2013


Abraxane







Celgene Europe Limited




1 Longwalk Road, Stockley Park, Uxbridge




UB11 1DB,




United Kingdom






EU/1/07/428


30.12.2013




20.12.2013


Advate







Baxter AG




Industriestraße 67,




A-1221 Wien,




Österreich






EU/1/03/271


6.1.2014




20.12.2013


Atriance







Glaxo Group Ltd




980 Great West Road, Brentford, Middlesex,




TW8 9GS,




United Kingdom






EU/1/07/403


2.1.2014




20.12.2013


Caprelsa







AstraZeneca AB




SE-151 85 Södertälje,




Sverige






EU/1/11/749


27.12.2013




20.12.2013


Comtan







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/98/081


2.1.2014




20.12.2013


ellaOne







Laboratoire HRA Pharma




15 rue Béranger,




F-75003 Paris,




France






EU/1/09/522


24.12.2013




20.12.2013


Iclusig







ARIAD Pharma Ltd




Brooklands Business Park, Wellington Way, Weybridge,




KT13 0TT,




United Kingdom






EU/1/13/839


27.12.2013




20.12.2013


Ivemend







Merck Sharp & Dohme Limited




Hertford Road, Hoddesdon, Hertfordshire




EN11 9BU,




United Kingdom






EU/1/07/437


2.1.2014




20.12.2013


Lantus







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/00/134


27.12.2013




20.12.2013


Lumigan







Allergan Pharmaceuticals Ireland




Castlebar Road, Westport, County Mayo,




Ireland






EU/1/02/205


2.1.2014




20.12.2013


Mixtard







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/02/231


27.12.2013




20.12.2013


Nplate







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/08/497


24.12.2013




20.12.2013


Optisulin







Sanofi-Aventis Deutschland GmbH




D-65926 Frankfurt am Main,




Deutschland






EU/1/00/133


27.12.2013




20.12.2013


Pioglitazone Accord







Accord Healthcare Limited




Sage House, 319 Pinner Road, North Harrow, Middlesex,




HA1 4HF,




United Kingdom






EU/1/11/722


24.12.2013




20.12.2013


Prolia







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/10/618


24.12.2013




20.12.2013


Sabervel







Pharmathen S.A.




Dervenakion 6,




15351 Pallini Attiki,




Ελλάδα






EU/1/12/765


24.12.2013




20.12.2013


Tasigna







Novartis Europharm Limited




Wimblehurst Road, Horsham, West Sussex




RH12 5AB,




United Kingdom






EU/1/07/422


2.1.2014




20.12.2013


Vizarsin







Krka, d. d., Novo mesto




Šmarješka cesta 6,




8501 Novo mesto,




Slovenija






EU/1/09/551


24.12.2013




20.12.2013


VPRIV







Shire Pharmaceuticals Ireland Limited




5 River Walk, Citywest Business Campus, Dublin 24,




Ireland






EU/1/10/646


24.12.2013




20.12.2013


Xaluprine







Nova Laboratories Limited




Martin House, Gloucester Crescent, Wigston Leicester,




LE18 4YL,




United Kingdom






EU/1/11/727


24.12.2013







—   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 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




4.12.2013


BROADLINE


Fipronil/ S-methoprene/ Eprinomectin/ Praziquantel







Merial




29 avenue Tony Garnier,




F-69007 Lyon,




France






EU/2/13/157


Spot-on solution


QP54AA54


6.12.2013




4.12.2013


Vectra 3D


dinotefuran, pyriproxyfen, permethrin







CEVA SANTE ANIMALE




10 avenue de la Ballastière,




F-33500 Libourne,




France






EU/2/13/156


Spot-on solution


QP53AC54


6.12.2013







—   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




3.12.2013


Emdocam







Emdoka bvba




J. Lijsenstraat 16,




B-2321 Hoogstraten,




België






EU/2/11/128


6.12.2013




3.12.2013


Meloxidolor







Le Vet Beheer B.V.




Wilgenweg 7,




NL-3421 TV Oudewater,




Nederland






EU/2/13/148


6.12.2013




4.12.2013


Aivlosin







ECO Animal Health Ltd




78 Coombe Road, New Malden, Surrey




KT3 4QS




United Kingdom






EU/2/04/044


6.12.2013




9.12.2013


Acticam







Ecuphar NV




Legeweg 157-I,




B-8020 Oostkamp,




België






EU/2/08/088


11.12.2013




13.12.2013


Porcilis PCV







Intervet International B.V.




Wim de Körverstraat 35,




NL-5831 AN Boxmeer,




Nederland






EU/2/08/091


17.12.2013




13.12.2013


Prac-Tic







Novartis Sanidad Animal S.L.




Calle de la Marina, 206,




E-08013 Barcelona,




España






EU/2/06/066


17.12.2013




18.12.2013


Meloxidyl







CEVA SANTE ANIMALE




10 avenue de la Ballastière,




F-33500 Libourne,




France






EU/2/06/070


20.12.2013




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.