Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-08-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2016312EN.01000101.xml










26.8.2016   


EN


Official Journal of the European Union


C 312/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2016 to 31 July 2016
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 312/01)
—   Issuing of a marketing authorisation (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




1.7.2016


Zinbryta


daclizumab


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


EU/1/16/1107


Solution for injection


L04AC01


5.7.2016




6.7.2016


EndolucinBeta


Lutetium (177 Lu) chloride


ITG Isotope Technologies Garching GmbH
Lichtenbergstr. 1, D-85748 Garching, Deutschland


EU/1/16/1105


Radiopharmaceutical precursor, solution


Pending


8.7.2016




6.7.2016


Epclusa


sofosbuvir/velpatasvir


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


EU/1/16/1116


Film-coated tablet


Pending


8.7.2016




15.7.2016


Qtern


saxagliptin/dapagliflozin


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/16/1108


Film-coated tablet


A10BD21


19.7.2016




22.7.2016


Bortezomib Hospira


bortezomib


Hospira UK Limited
Horizon, Honey Lane, Hurley, SL6 6RJ, United Kingdom


EU/1/16/1114


Powder for solution for infusion


L01XX32


26.7.2016




22.7.2016


Bortezomib SUN


bortezomib


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


EU/1/16/1102


Powder for solution for injection


L01XX32


26.7.2016




22.7.2016


Pemetrexed Fresenius Kabi


pemetrexed


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


EU/1/16/1115


Powder for concentrate for solution for infusion


L01BA04


26.7.2016




22.7.2016


Zepatier


elbasvir/grazoprevir


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


EU/1/16/1119


Film-coated tablet


J05A


26.7.2016




—   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




4.7.2016


BiResp Spiromax


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


EU/1/14/921


6.7.2016




4.7.2016


Clopidogrel Apotex


Apotex Europe B.V.
Darwinweg 20, NL- 2333 CR Leiden, Nederland


EU/1/09/568


6.7.2016




4.7.2016


Duloxetine Lilly


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/14/972


6.7.2016




4.7.2016


DuoResp Spiromax


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


EU/1/14/920


6.7.2016




6.7.2016


Arzerra


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


EU/1/10/625


8.7.2016




6.7.2016


Budesonide/Formoterol Teva


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


EU/1/14/948


8.7.2016




6.7.2016


Mircera


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


EU/1/07/400


8.7.2016




6.7.2016


Nivestim


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/10/631


8.7.2016




6.7.2016


Olanzapine Mylan


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


EU/1/08/475


12.7.2016




6.7.2016


Oprymea


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


EU/1/08/469


8.7.2016




6.7.2016


Rapilysin


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland


EU/1/96/018


8.7.2016




6.7.2016


Vylaer Spiromax


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


EU/1/14/949


8.7.2016




6.7.2016


Xarelto


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/08/472


8.7.2016




8.7.2016


Otezla


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


EU/1/14/981


12.7.2016




8.7.2016


Revlimid


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


EU/1/07/391


12.7.2016




14.7.2016


Ariclaim


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/04/283


18.7.2016




14.7.2016


Votrient


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


EU/1/10/628


18.7.2016




15.7.2016


ATryn


GTC Biotherapeutics UK Limited
10 Norwich Street, London EC4A 1BD, United Kingdom


EU/1/06/355


19.7.2016




15.7.2016


Exjade


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


EU/1/06/356


19.7.2016




15.7.2016


Jardiance


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


EU/1/14/930


19.7.2016




15.7.2016


Komboglyze


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/731


19.7.2016




15.7.2016


Leflunomide medac


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


EU/1/10/637


19.7.2016




15.7.2016


Levetiracetam Teva


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


EU/1/11/701


19.7.2016




15.7.2016


Luminity


Lantheus MI UK Limited
Festival House, 39 Oxford Street, Newbury, Berkshire RG14 1JG, United Kingdom


EU/1/06/361


19.7.2016




15.7.2016


NeoRecormon


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


EU/1/97/031


19.7.2016




15.7.2016


Noxafil


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


EU/1/05/320


19.7.2016




15.7.2016


Opsumit


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


EU/1/13/893


19.7.2016




15.7.2016


Pramipexole Accord


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


EU/1/11/728


19.7.2016




15.7.2016


Remicade


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


EU/1/99/116


19.7.2016




15.7.2016


Sprycel


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


EU/1/06/363


19.7.2016




15.7.2016


Stelara


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


EU/1/08/494


19.7.2016




15.7.2016


Synjardy


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


EU/1/15/1003


19.7.2016




15.7.2016


Temozolomide HEXAL


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/10/616


19.7.2016




15.7.2016


Temozolomide Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/10/617


19.7.2016




15.7.2016


Thalidomide Celgene


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


EU/1/08/443


19.7.2016




15.7.2016


Thyrogen


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


EU/1/99/122


19.7.2016




15.7.2016


Zoledronic acid Teva Pharma


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


EU/1/12/772


19.7.2016




22.7.2016


Byetta


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/06/362


26.7.2016




22.7.2016


Cialis


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/02/237


26.7.2016




22.7.2016


Conbriza


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


EU/1/09/511


26.7.2016




22.7.2016


Cymbalta


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/04/296


26.7.2016




22.7.2016


EDURANT


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


EU/1/11/736


26.7.2016




22.7.2016


Eviplera


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/11/737


26.7.2016




22.7.2016


Granupas


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


EU/1/13/896


26.7.2016




22.7.2016


Harvoni


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


26.7.2016




22.7.2016


Levetiracetam Accord


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


EU/1/11/712


26.7.2016




22.7.2016


Noxafil


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


EU/1/05/320


26.7.2016




22.7.2016


Ofev


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


EU/1/14/979


26.7.2016




22.7.2016


Rebif


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


EU/1/98/063


27.7.2016




22.7.2016


Ryzodeg


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


EU/1/12/806


26.7.2016




22.7.2016


Temomedac


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


EU/1/09/605


26.7.2016




22.7.2016


Vizamyl


GE Healthcare Ltd
Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom


EU/1/14/941


26.7.2016




22.7.2016


Vyndaqel


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


EU/1/11/717


26.7.2016




22.7.2016


Xeristar


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/04/297


26.7.2016




29.7.2016


Cervarix


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


EU/1/07/419


2.8.2016




29.7.2016


Firdapse


BioMarin Europe Ltd
10 Bloomsbury Way, London WC1A 2SL, United Kingdom


EU/1/09/601


2.8.2016




29.7.2016


Imnovid


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


EU/1/13/850


2.8.2016




29.7.2016


Jakavi


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


EU/1/12/773


2.8.2016




29.7.2016


KEYTRUDA


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


EU/1/15/1024


2.8.2016




29.7.2016


Nevanac


Alcon Laboratories (UK) Ltd
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/07/433


2.8.2016




29.7.2016


ReFacto AF


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


EU/1/99/103


3.8.2016




29.7.2016


Revatio


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


EU/1/05/318


3.8.2016




29.7.2016


Ribavirin Mylan


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


EU/1/10/634


4.8.2016




29.7.2016


RoActemra


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


EU/1/08/492


2.8.2016




29.7.2016


XALKORI


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


EU/1/12/793


4.8.2016




—   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




29.7.2016


ChondroCelect


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


EU/1/09/563


2.8.2016




—   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




4.7.2016


Suvaxyn CSF Marker


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


EU/2/14/179


6.7.2016




8.7.2016


Oxyglobin


OPK Biotech Netherlands BV
Teleportboulevard 140, NL-1043 EJ Amsterdam, Nederland


EU/2/99/015


12.7.2016




19.7.2016


ERYSENG


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170- Amer (Girona), España


EU/2/14/166


21.7.2016




25.7.2016


Eurican Herpes 205


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


EU/2/01/029


27.7.2016




25.7.2016


Osurnia


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM


EU/2/14/170


27.7.2016




25.7.2016


Porcilis ColiClos


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


EU/2/12/141


27.7.2016




25.7.2016


Prac-Tic


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM


EU/2/06/066


27.7.2016




25.7.2016


STARTVAC


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170- Amer (Girona), España


EU/2/08/092


27.7.2016




29.7.2016


Ingelvac CircoFLEX


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/07/079


2.8.2016




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.