Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-10-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2016399EN.01000101.xml










28.10.2016   


EN


Official Journal of the European Union


C 399/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2016 to 30 September 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 399/01)






—



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




9.9.2016


CABOMETYX


cabozantinib


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/16/1136


Film-coated tablet


L01XE26


13.9.2016




15.9.2016


Inhixa


enoxaparin sodium


Techdow Europe AB
Banérgatan 36, 75237 Uppsala, Sverige


EU/1/16/1132


Solution for injection


B01AB05


19.9.2016




15.9.2016


Mysildecard


sildenafil


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/16/1134


Film-coated tablet


G04BE03


19.9.2016




15.9.2016


Sialanar


glycopyrronium bromide


Proveca Limited
Daresbury Innovation Centre, Keckwick Lane, Daresbury, Halton, Cheshire, WA4 4FS, United Kingdom


EU/1/16/1135


Oral solution


A03AB02


19.9.2016




15.9.2016


Tenofovir disoproxil Zentiva


tenofovir disoproxil


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


EU/1/16/1127


Film-coated tablet


J05AF07


19.9.2016




15.9.2016


Thorinane


enoxaparin sodium


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


EU/1/16/1131


Solution for injection


B01AB05


19.9.2016




19.9.2016


Truberzi


eluxadoline


Aptalis Pharma SAS
5/6 Place de l’Iris — La Défense 5 92400 Courbevoie France


EU/1/16/1126


Film-coated tablet


Pending


21.9.2016










—



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




2.9.2016


Enzepi


Allergan Pharmaceuticals International Limited,
Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland


EU/1/16/1113


6.9.2016




2.9.2016


Extavia


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


EU/1/08/454


6.9.2016




2.9.2016


Kengrexal


Chiesi Farmaceutici S.P.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/15/994


6.9.2016




2.9.2016


Ofev


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


EU/1/14/979


6.9.2016




5.9.2016


Nimvastid


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


EU/1/09/525


7.9.2016




8.9.2016


Betaferon


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/95/003


12.9.2016




8.9.2016


Budesonide/Formoterol Teva Pharma B.V.


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


EU/1/14/950


12.9.2016




8.9.2016


Caprelsa


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


EU/1/11/749


12.9.2016




8.9.2016


DUAVIVE


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


EU/1/14/960


12.9.2016




8.9.2016


Insulatard


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


EU/1/02/233


12.9.2016




8.9.2016


Levetiracetam Actavis


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


EU/1/11/713


12.9.2016




8.9.2016


Lucentis


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


EU/1/06/374


12.9.2016




8.9.2016


Panretin


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


EU/1/00/149


12.9.2016




8.9.2016


Plegridy


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


EU/1/14/934


12.9.2016




8.9.2016


Protaphane


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


EU/1/02/234


12.9.2016




9.9.2016


Ameluz


Biofrontera Bioscience GmbH
Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland


EU/1/11/740


13.9.2016




9.9.2016


Efavirenz Teva


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


EU/1/11/742


13.9.2016




9.9.2016


Elaprase


Shire Human Genetic Therapies AB
Vasagatan 7, 111 20 Stockholm, Sverige


EU/1/06/365


13.9.2016




9.9.2016


Eurartesim


Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
Viale Shakespeare 47, 00144 Roma, Italia


EU/1/11/716


13.9.2016




9.9.2016


Laventair


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/14/899


16.9.2016




9.9.2016


Revlimid


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


EU/1/07/391


13.9.2016




9.9.2016


Tandemact


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


EU/1/06/366


13.9.2016




9.9.2016


Tracleer


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


EU/1/02/220


13.9.2016




9.9.2016


Velphoro


Vifor Fresenius Medical Care Renal Pharma France
7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France


EU/1/14/943


15.9.2016




9.9.2016


Xolair


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


EU/1/05/319


13.9.2016




15.9.2016


Arava


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


EU/1/99/118


19.9.2016




15.9.2016


Arixtra


Aspen Pharma Trading Limited
3016 Lake Drive Citywest Business Campus Dublin 24 Ireland


EU/1/02/206


19.9.2016




15.9.2016


Evoltra


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


EU/1/06/334


19.9.2016




15.9.2016


Fosavance


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


EU/1/05/310


19.9.2016




15.9.2016


Ganfort


Allergan Pharmaceuticals Ireland, (514125)
Castlebar Road, Westport, County Mayo, Ireland


EU/1/06/340


19.9.2016




15.9.2016


Ibandronic Acid Teva


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


EU/1/10/642


19.9.2016




15.9.2016


Intelence


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


EU/1/08/468


19.9.2016




15.9.2016


PANTECTA Control


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


EU/1/09/518


19.9.2016




15.9.2016


Trulicity


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


EU/1/14/956


19.9.2016




15.9.2016


Zydelig


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/938


19.9.2016




16.9.2016


Lamivudine Teva Pharma B.V.


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


EU/1/09/596


20.9.2016




19.9.2016


Adrovance


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


EU/1/06/364


21.9.2016




19.9.2016


Enbrel


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


EU/1/99/126


21.9.2016




19.9.2016


Fycompa


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


EU/1/12/776


21.9.2016




19.9.2016


Repaglinide Accord


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


EU/1/11/743


21.9.2016




19.9.2016


Soliris


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


EU/1/07/393


21.9.2016




19.9.2016


Sovaldi


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/894


21.9.2016




19.9.2016


Vantavo


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


EU/1/09/572


21.9.2016




19.9.2016


Zydelig


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/938


21.9.2016




22.9.2016


Anoro


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/14/898


26.9.2016




22.9.2016


Blincyto


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


EU/1/15/1047


26.9.2016




22.9.2016


EVARREST


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, B-1831 Diegem, België


EU/1/13/868


26.9.2016




22.9.2016


Instanyl


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


EU/1/09/531


26.9.2016




22.9.2016


Leflunomide ratiopharm


ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/10/654


26.9.2016




22.9.2016


Pregabalin Sandoz GmbH


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1012


26.9.2016




22.9.2016


Saxenda


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


EU/1/15/992


26.9.2016




22.9.2016


Stayveer


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


EU/1/13/832


26.9.2016




22.9.2016


Victoza


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


EU/1/09/529


26.9.2016




22.9.2016


Zelboraf


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


EU/1/12/751


26.9.2016




26.9.2016


Colobreathe


Forest Laboratories UK Ltd.
Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom


EU/1/11/747


28.9.2016




26.9.2016


Tivicay


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


EU/1/13/892


28.9.2016




30.9.2016


Cometriq


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/13/890


4.10.2016




30.9.2016


Moventig


Kyowa Kirin Limited
Galabank Business Park, Galashiels, TD1 1QH, United Kingdom


EU/1/14/962


4.10.2016




30.9.2016


Vantobra


PARI Pharma GmbH
Moosstrasse 3, D-82319 Starnberg, Deutschland


EU/1/14/932


4.10.2016










—



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




19.9.2016


PANTECTA Control


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


EU/1/09/518


21.9.2016










—



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




22.9.2016


ERAVAC


rabbit haemorrhagic disease vaccine (inactivated)


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


EU/2/16/199


Emulsion for injection


QI08AA


26.9.2016










—



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




19.9.2016


Reconcile


Nexcyon Pharmaceuticals Ltd
First Floor Denmark House, 143 High Street, Chalfont St Peter SL9 9QL, United Kingdom


EU/2/08/080


29.9.2016




28.9.2016


Coliprotec F4


Prevtec Microbia GmbH
Geyerspergerstr 27, 80689 München, Deutschland


EU/2/14/180


30.9.2016




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.