Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-08-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015285EN.01000101.xml










28.8.2015   


EN


Official Journal of the European Union


C 285/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2015/C 285/01)
—   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




3.7.2015


Hetlioz


tasimelteon


Vanda Pharmaceuticals Limited
222 Regent Street, London W1B 5TR, United Kingdom


EU/1/15/1008


Capsule, hard


N05CH03


7.7.2015




13.7.2015


EVOTAZ


atazanavir/cobicistat


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


EU/1/15/1025


Film-coated tablet


J05AR15


15.7.2015




17.7.2015


KEYTRUDA


pembrolizumab


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


EU/1/15/1024


Powder for concentrate for solution for infusion


L01XC18


21.7.2015




17.7.2015


Pregabalin Zentiva


pregabalin


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1021


Capsule, hard


N03AX16


21.7.2015




17.7.2015


Repatha


evolocumab


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


EU/1/15/1016


Solution for injection in a pre-filled syringe


C10AX13


21.7.2015




20.7.2015


Bortezomib Accord


bortezomib


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/15/1019


Powder for solution for injection


L01XX32


23.7.2015




20.7.2015


Nivolumab BMS


nivolumab


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


EU/1/15/1026


Concentrate for solution for infusion


L01XC17


23.7.2015




28.7.2015


Omidria


phenylephrine/ketorolac


Omeros London Limited
Berkeley Square, London, W1J 6BD, United Kingdom


EU/1/15/1018


Concentrate for solution for intraocular irrigation


Pending


30.7.2015




—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




3.7.2015


Lympreva


Biovest Europe Limited
Evershed House, 70 Great Bridgewater St., Manchester M1 5ES, United Kingdom


—


7.7.2015




—   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




3.7.2015


ADCETRIS


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/12/794


7.7.2015




3.7.2015


Bemfola


FINOX Biotech AG
Gewerbestrasse 7, FL-9496 Balzers, Liechtenstein


EU/1/13/909


8.7.2015




3.7.2015


Competact


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/06/354


7.7.2015




3.7.2015


Docetaxel Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/12/769


7.7.2015




3.7.2015


Docetaxel Kabi


Fresenius Kabi Oncology Plc.
Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom


EU/1/12/770


7.7.2015




3.7.2015


Fampyra


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/11/699


7.7.2015




3.7.2015


GILENYA


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/11/677


7.7.2015




3.7.2015


Hemangiol


Pierre Fabre Dermatologie
45 place Abel Gance, F-92100 Boulogne, France


EU/1/14/919


7.7.2015




3.7.2015


IMBRUVICA


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


EU/1/14/945


7.7.2015




3.7.2015


Neuraceq


Piramal Imaging Limited
Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom


EU/1/13/906


7.7.2015




3.7.2015


Pradaxa


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


EU/1/08/442


7.7.2015




3.7.2015


Viramune


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


EU/1/97/055


7.7.2015




3.7.2015


Zoledronic acid medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/12/779


7.7.2015




3.7.2015


Zometa


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/01/176


7.7.2015




8.7.2015


Ambirix


GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89, 1330 Rixensart, Belgique


EU/1/02/224


10.7.2015




8.7.2015


CONTROLOC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/515


10.7.2015




8.7.2015


DuoResp Spiromax


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


EU/1/14/920


13.7.2015




8.7.2015


Flebogamma DIF


Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa


EU/1/07/404


10.7.2015




8.7.2015


Foscan


biolitec pharma ltd.
Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland.


EU/1/01/197


10.7.2015




8.7.2015


Iasibon


Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/10/659


10.7.2015




8.7.2015


Mimpara


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


EU/1/04/292


10.7.2015




8.7.2015


PANTECTA Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/518


10.7.2015




8.7.2015


PANTOLOC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/519


10.7.2015




8.7.2015


PANTOZOL Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/517


10.7.2015




8.7.2015


Perjeta


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


EU/1/13/813


10.7.2015




8.7.2015


Pregabalin Pfizer


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


EU/1/14/916


10.7.2015




8.7.2015


Ranexa


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/08/462


10.7.2015




8.7.2015


Remicade


Janssen Biologics B.V.
Einsteinweg 101, NL-2333 CB Leiden, Nederland


EU/1/99/116


10.7.2015




8.7.2015


SOMAC Control


Takeda GmbH, (HRB 701016)
Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland


EU/1/09/516


10.7.2015




8.7.2015


Tandemact


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/06/366


10.7.2015




8.7.2015


Vaniqa


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/01/173


10.7.2015




8.7.2015


Vimizim


BioMarin Europe Ltd
164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom


EU/1/14/914


10.7.2015




8.7.2015


Yttriga


Eckert & Ziegler Radiopharma GmbH
Robert-Rössle-Str. 10, D-13125 Berlin, Deutschland


EU/1/05/322


10.7.2015




13.7.2015


Xgeva


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


EU/1/11/703


15.7.2015




13.7.2015


Zoledronic acid Teva Generics


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/14/912


15.7.2015




17.7.2015


Aflunov


Novartis Vaccines Influenza S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/10/658


22.7.2015




17.7.2015


Brilique


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/10/655


21.7.2015




17.7.2015


Circadin


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


EU/1/07/392


21.7.2015




17.7.2015


Exjade


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/06/356


21.7.2015




17.7.2015


HALAVEN


Eisai Europe Limited
European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom


EU/1/11/678


21.7.2015




17.7.2015


JETREA


ThromboGenics NV
Gaston Geenslaan 1, B-3001 Leuven, België


EU/1/13/819


22.7.2015




17.7.2015


Latuda


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/14/913


21.7.2015




17.7.2015


PecFent


Archimedes Development Ltd
Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom


EU/1/10/644


21.7.2015




17.7.2015


Rapiscan


Rapidscan Pharma Solutions EU Ltd
Regent’s Place, 338 Euston Road, London NW1 3BT, United Kingdom


EU/1/10/643


21.7.2015




17.7.2015


RoActemra


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


EU/1/08/492


21.7.2015




17.7.2015


Somavert


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


EU/1/02/240


21.7.2015




17.7.2015


Sylvant


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


EU/1/14/928


22.7.2015




17.7.2015


Votrient


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/10/628


21.7.2015




17.7.2015


XALKORI


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


EU/1/12/793


21.7.2015




20.7.2015


Lucentis


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/06/374


23.7.2015




20.7.2015


Replagal


Shire Human Genetic Therapies AB
Svärdvägen 11D, SE-182 33 Danderyd, Sverige


EU/1/01/189


23.7.2015




20.7.2015


Soliris


Alexion Europe SAS
1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France


EU/1/07/393


23.7.2015




28.7.2015


Abraxane


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom


EU/1/07/428


30.7.2015




28.7.2015


Brinavess


Cardiome UK Limited
Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom


EU/1/10/645


30.7.2015




28.7.2015


Humira


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/03/256


30.7.2015




28.7.2015


Lantus


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


EU/1/00/134


30.7.2015




28.7.2015


Levemir


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


EU/1/04/278


30.7.2015




28.7.2015


Mycamine


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/08/448


30.7.2015




28.7.2015


Neoclarityn


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


EU/1/00/161


31.7.2015




28.7.2015


Nimenrix


GlaxoSmithKline Biologicals S.A.
rue de l’Institut 89, 1330 Rixensart, Belgique


EU/1/12/767


31.7.2015




28.7.2015


Opsumit


Actelion Registration Ltd
Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/13/893


30.7.2015




28.7.2015


Osigraft


Olympus Biotech International Limited
40 Upper Mount Street, Dublin 2, Ireland


EU/1/01/179


30.7.2015




28.7.2015


Perjeta


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


EU/1/13/813


30.7.2015




28.7.2015


Prepandemic Influenza


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/10/657


31.7.2015




28.7.2015


Stayveer


Marklas Nederland B.V.
Beneluxlaan 2b, NL-3446 GR Woerden, Nederland


EU/1/13/832


30.7.2015




28.7.2015


Temomedac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/09/605


30.7.2015




28.7.2015


Temozolomide SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland


EU/1/11/697


30.7.2015




28.7.2015


Tivicay


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/13/892


30.7.2015




28.7.2015


Translarna


PTC Therapeutics International Limited
77 Sir John Rogerson’s Quay, Dublin 2, Ireland


EU/1/13/902


30.7.2015




28.7.2015


Vizarsin


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/09/551


31.7.2015




28.7.2015


Votubia


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/11/710


30.7.2015




28.7.2015


Xarelto


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/08/472


30.7.2015




28.7.2015


Zebinix


BIAL — Portela & Ca, SA
A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal


EU/1/09/514


30.7.2015




28.7.2015


Zytiga


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


EU/1/11/714


30.7.2015




29.7.2015


Glubrava


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/07/421


31.7.2015




29.7.2015


Ketek


Aventis Pharma S.A.
20, Avenue Raymond Aron, F-92160 ANTONY, France


EU/1/01/191


31.7.2015




31.7.2015


Abseamed


Medice Arzneimittel Pütter GmbH & Co KG
Kuhloweg 37, D-58638 Iserlohn, Deutschland


EU/1/07/412


4.8.2015




31.7.2015


Binocrit


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/07/410


4.8.2015




31.7.2015


Epoetin alfa Hexal


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/07/411


4.8.2015




31.7.2015


Picato


Leo Pharma A/S
Industriparken 55, DK-2750 Ballerup, Danmark


EU/1/12/796


4.8.2015




31.7.2015


Voncento


CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/13/857


4.8.2015




—   Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)









Date of the decision


Name of the medicinal product


Holder of the marketing authorization


Number of the entry in the Community Register


Date of notification




3.7.2015


Sonata


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


EU/1/99/102


7.7.2015




13.7.2015


Zoledronic acid Teva Generics


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/14/912


15.7.2015




—   Issuing 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


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




3.7.2015


Canigen L4


Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas


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


EU/2/15/183


Suspension for injection


QI07AB01


7.7.2015




3.7.2015


Innovax-ILT


Live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus


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


EU/2/15/182


Suspension and solvent for suspension for injection


QI01AD


7.7.2015




31.7.2015


UpCard


Torasemide


Vétoquinol SA
Magny-Vernois, 70200 Lure, France


EU/2/15/184


Tablet


QC03CA04


4.8.2015




—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Rejected










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




8.7.2015


Lodipressin


Le Vet Beheer B.V.
Wilgenweg 7, NL-3421 TV Oudewater, Nederland


—


10.7.2015




—   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




13.7.2015


SevoFlo


Abbott Laboratories Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead Berkshire SL6 4XE, United Kingdom


EU/2/02/035


15.7.2015




17.7.2015


Incurin


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


EU/2/00/018


21.7.2015




20.7.2015


Contacera


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/12/144


23.7.2015




28.7.2015


Poulvac E. coli


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/12/140


30.7.2015




31.7.2015


BTVPUR AlSap 2-4


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/10/108


4.8.2015




31.7.2015


Coxevac


CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France


EU/2/10/110


4.8.2015




—   Withdrawal of a marketing authorization (Article 38 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




8.7.2015


ProMeris


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


EU/2/06/064


10.7.2015




8.7.2015


ProMeris Duo


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


EU/2/06/065


10.7.2015




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




30, Churchill Place, Canary Wharf




UK — LONDON E14 5EU






(1)  OJ L 136, 30.4.2004, p. 1.