Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014 (published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-03-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014091EN.01000201.xml










28.3.2014   


EN


Official Journal of the European Union


C 91/2





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 28 February 2014

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

2014/C 91/02
—   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




20.2.2014


Izba


travoprost







Alcon Laboratories (UK) Ltd.




Frimley Business Park, Frimley,




Camberley, Surrey, GU16 7SR,




United Kingdom






EU/1/13/905


Eye drops, solution


S01EE04


24.2.2014




20.2.2014


Neuraceq


florbetaben (18F)







Piramal Imaging GmbH




Tegeler Strasse 6-7




13353 Berlin – Deutschland






EU/1/13/906


Solution for injection


V09AX06


24.2.2014




21.2.2014


Mirvaso


brimonidine







Galderma International




Tour Europlaza,




20 avenue André Prothin,




La Défense 4,




La Défense Cedex 92927,




France






EU/1/13/904


Gel


D11AX21


25.2.2014







—   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




6.2.2014


Cystadane







Orphan Europe S.A.R.L.




Immeuble Le Wilson,




70 avenue du Général de Gaulle,




F-92 800 Puteaux,




France






EU/1/06/379


10.2.2014




6.2.2014


Humira







AbbVie Ltd




Maidenhead,




SL6 4XE,




United Kingdom






EU/1/03/256


10.2.2014




6.2.2014


Repso







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/11/674


11.2.2014




6.2.2014


Taxotere







Aventis Pharma S.A.




20 avenue Raymond Aron,




F-92165 Antony CEDEX,




France






EU/1/95/002


10.2.2014




11.2.2014


Pravafenix







LABORATOIRES SMB SA




26-28 rue de la Pastorale / 26-28 Herdersliedstraat,




1080 Brussel/Bruxelles,




Belgique/België






EU/1/11/679


13.2.2014




11.2.2014


Sycrest







Organon N.V.




Kloosterstraat 6,




NL-5349 AB Oss,




Nederland






EU/1/10/640


13.2.2014




11.2.2014


Temozolomide Teva







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/09/606


14.2.2014




12.2.2014


Mozobil







Genzyme Europe B.V.




Gooimeer 10,




NL-1411 DD Naarden,




Nederland






EU/1/09/537


13.2.2014




13.2.2014


Lyrica







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/04/279


17.2.2014




17.2.2014


Conbriza







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/09/511


19.2.2014




17.2.2014


Modigraf







Astellas Pharma Europe B.V.




Sylviusweg 62,




NL-2333 BE Leiden,




Nederland






EU/1/09/523


19.2.2014




17.2.2014


Victrelis







Merck Sharp & Dohme Limited




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/11/704


19.2.2014




20.2.2014


Betmiga







Astellas Pharma Europe B.V.




Sylviusweg 62,




NL-2333 BE Leiden,




Nederland






EU/1/12/809


24.2.2014




20.2.2014


Bosulif







Pfizer Limited




Ramsgate Road,




Sandwich,




Kent CT13 9NJ,




United Kingdom






EU/1/13/818


24.2.2014




20.2.2014


Capecitabine Accord







Accord Healthcare Limited




Sage House, 319 Pinner Road,




North Harrow,




Middlesex, HA1 4HF,




United Kingdom






EU/1/12/762


22.2.2014




20.2.2014


Capecitabine Teva







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/12/761


25.2.2014




20.2.2014


Constella







Almirall, S.A.




Ronda General Mitre, 151,




E-08022 Barcelona,




España






EU/1/12/801


24.2.2014




20.2.2014


Helixate NexGen







Bayer Pharma AG




D-13342 Berlin,




Deutschland






EU/1/00/144


24.2.2014




20.2.2014


KOGENATE Bayer







Bayer Pharma AG




D-13342 Berlin,




Deutschland






EU/1/00/143


24.2.2014




20.2.2014


Metalyse







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/00/169


24.2.2014




20.2.2014


Mycamine







Astellas Pharma Europe B.V.




Sylviusweg 62,




NL-2333 BE Leiden,




Nederland






EU/1/08/448


24.2.2014




20.2.2014


Nevirapine Teva







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/09/598


25.2.2014




20.2.2014


Zoledronic acid Actavis







Actavis Group PTC ehf.




Reykjavíkurvegur 76-78,




220 Hafnarfjörður,




Iceland






EU/1/12/759


24.2.2014




20.2.2014


Zoledronic acid Mylan







Mylan S.A.S




117 allée des Parcs,




F-69800 Saint Priest,




France






EU/1/12/786


24.2.2014




21.2.2014


Celsentri







ViiV Healthcare UK Limited




980 Great West Road,




Brentford,




Middlesex TW8 9GS,




United Kingdom






EU/1/07/418


25.2.2014




21.2.2014


CONTROLOC Control







Takeda GmbH




Byk-Gulden-Straße 2,




D-78467 Konstanz,




Deutschland






EU/1/09/515


25.2.2014




21.2.2014


Fertavid







Merck Sharp & Dohme Limited




Hertford Road,




Hoddesdon,




Hertfordshire EN11 9BU,




United Kingdom






EU/1/09/510


25.2.2014




21.2.2014


NeuroBloc







Eisai Limited




European Knowledge Centre,




Mosquito Way, Hatfield,




Hertfordshire AL10 9SN,




United Kingdom






EU/1/00/166


25.2.2014




21.2.2014


NovoThirteen







Novo Nordisk A/S




Novo Allé,




DK-2880 Bagsvaerd,




Danmark






EU/1/12/775


25.2.2014




21.2.2014


PANTECTA Control







Takeda GmbH




Byk-Gulden-Straße 2,




D-78467 Konstanz,




Deutschland






EU/1/09/518


25.2.2014




21.2.2014


PANTOLOC Control







Takeda GmbH




Byk-Gulden-Straße 2,




D-78467 Konstanz,




Deutschland






EU/1/09/519


25.2.2014




21.2.2014


PANTOZOL Control







Takeda GmbH




Byk-Gulden-Straße 2,




D-78467 Konstanz,




Deutschland






EU/1/09/517


25.2.2014




21.2.2014


SOMAC Control







Takeda GmbH




Byk-Gulden-Straße 2,




D-78467 Konstanz,




Deutschland






EU/1/09/516


25.2.2014




21.2.2014


Stelara







Janssen-Cilag International NV




Turnhoutseweg 30,




B-2340 Beerse,




België






EU/1/08/494


25.2.2014




21.2.2014


Synflorix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/09/508


25.2.2014




21.2.2014


Vectibix







Amgen Europe B.V.




Minervum 7061,




NL-4817 ZK Breda,




Nederland






EU/1/07/423


25.2.2014




28.2.2014


Adjupanrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/09/578


4.3.2014




28.2.2014


Capecitabine medac







medac Gesellschaft für klinische Spezialpräparate mbH




Theaterstr. 6,




D-22880 Wedel,




Deutschland






EU/1/12/802


4.3.2014




28.2.2014


Effentora







Teva Pharma B.V.




Computerweg 10,




NL-3542 DR Utrecht,




Nederland






EU/1/08/441


5.3.2014




28.2.2014


Instanyl







Takeda Pharma A/S




Langebjerg 1,




DK-4000 Roskilde,




Danmark






EU/1/09/531


4.3.2014




28.2.2014


Ixiaro







Valneva Austria GmbH




Campus Vienna Biocenter 3,




A-1030 Wien,




Österreich






EU/1/08/501


4.3.2014




28.2.2014


Menveo







Novartis Vaccines and Diagnostics S.r.l.




Via Fiorentina, 1,




53100 Siena,




Italia






EU/1/10/614


4.3.2014




28.2.2014


Mirapexin







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/97/051


4.3.2014




28.2.2014


PecFent







Archimedes Development Ltd




Albert Einstein Centre,




Nottingham Science and Technology Park,




University Boulevard NG7 2 TN Nottingham,




United Kingdom






EU/1/10/644


4.3.2014




28.2.2014


Prepandrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/08/453


4.3.2014




28.2.2014


Pumarix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89,




1330 Rixensart,




Belgique






EU/1/10/664


3.3.2014




28.2.2014


Rebif







Merck Serono Europe Limited




56, Marsh Wall,




London E14 9TP,




United Kingdom






EU/1/98/063


4.3.2014




28.2.2014


Samsca







Otsuka Pharmaceutical Europe Ltd.




Gallions, Wexham Springs,




Framewood Road,




Wexham, SL3 6PJ,




United Kingdom






EU/1/09/539


4.3.2014




28.2.2014


Sifrol







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/97/050


4.3.2014




28.2.2014


Temozolomide Hospira







Hospira UK Limited




Queensway,




Royal Leamington Spa,




Warwickshire CV31 3RW,




United Kingdom






EU/1/10/615


4.3.2014




28.2.2014


Xolair







Novartis Europharm Limited




Wimblehurst Road,




Horsham,




West Sussex RH12 5AB,




United Kingdom






EU/1/05/319


4.3.2014







—   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




17.2.2014


Onduarp







Boehringer Ingelheim International GmbH




Binger Straße 173,




D-55216 Ingelheim am Rhein,




Deutschland






EU/1/11/729


19.2.2014







—   Lift of suspension of a marketing authorization (Article 20 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




21.2.2014


Luminity







Lantheus MI UK Limited




Festival House,




39 Oxford Street,




Newbury,




Berkshire RG14 1JG,




United Kingdom






EU/1/06/361


25.2.2014








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




11.2.2014


Bravecto


Fluralaner







Intervet International B.V.




Wim de Körverstraat 35,




NL-5831 AN Boxmeer,




Nederland






EU/2/13/158


Chewable tablet


QP53BX


13.2.2014




11.2.2014


NexGard


afoxolaner







Merial




29 avenue Tony Garnier,




F-69007 Lyon,




France






EU/2/13/159


Chewable tablet


QP53BX04


13.2.2014







—   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




6.2.2014


Melovem







Dopharma Research B.V.




Zalmweg 24,




NL-4941 VX Raamsdonksveer,




Nederland






EU/2/09/098


10.2.2014




10.2.2014


Startvac







Laboratorios Hipra, S.A.




Avda. La Selva, 135,




E-17170- Amer (Girona),




España






EU/2/08/092


12.2.2014




13.2.2014


Contacera







Zoetis Belgium S.A.




Rue Laid Burniat 1,




1348 Louvain-La-Neuve,




Belgique






EU/2/12/144


17.2.2014




13.2.2014


Melosus







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13,




D-31303 Burgdorf,




Deutschland






EU/2/10/116


17.2.2014




20.2.2014


CaniLeish







VIRBAC S.A.




1ère Avenue - 2065 m - L.I.D.,




F-06516 Carros CEDEX,




France






EU/2/11/121


24.2.2014




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.