Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-01-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017028EN.01000101.xml










27.1.2017   


EN


Official Journal of the European Union


C 28/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2017/C 028/01)
* * *






—



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




5.12.2016


Venclyxto


venetoclax


AbbVie Ltd
Vanwall Road, Maidenhead, SL6 4UB, United Kingdom


EU/1/16/1138


Film-coated tablet


L01X


7.12.2016




8.12.2016


Emtricitabine/Tenofovir disoproxil Krka


emtricitabine/tenofovir disoproxil


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


EU/1/16/1151


Film-coated tablet


J05AR03


12.12.2016




8.12.2016


SomaKit TOC


edotreotide


Advanced Accelerator Applications
20 rue Diesel, F-1630 Saint-Genis-Pouilly, France


EU/1/16/1141


Powder for solution for injection


V09IX09


12.12.2016




8.12.2016


Tenofovir disoproxil Mylan


Tenofovir disoproxil


MYLAN S.A.S
117 Allée des Parcs, 69800 Saint-Priest, France


EU/1/16/1129


Film-coated tablet


J05AF07


12.12.2016




12.12.2016


OCALIVA


obeticholic acid


Intercept Pharma Ltd
2 Pancras Square, London N1C 4AG, United Kingdom


EU/1/16/1139


Film-coated tablet


A05AA04


15.12.2016




12.12.2016


Rekovelle


follitropin delta


Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark


EU/1/16/1150


 


G03GA10


14.12.2016




16.12.2016


Emtricitabine/Tenofovir disoproxil Mylan


emtricitabine/tenofovir disoproxil


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


EU/1/16/1133


Film-coated tablet


J05AR03


20.12.2016










—



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




2.12.2016


Aclasta


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


EU/1/05/308


6.12.2016




5.12.2016


Pioglitazone Accord


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


EU/1/11/722


7.12.2016




5.12.2016


Spedra


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


EU/1/13/841


7.12.2016




5.12.2016


Truberzi


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


EU/1/16/1126


7.12.2016




8.12.2016


Actraphane


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


EU/1/02/229


12.12.2016




8.12.2016


Actrapid


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


EU/1/02/230


12.12.2016




8.12.2016


Adenuric


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


EU/1/08/447


12.12.2016




8.12.2016


Bosulif


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


EU/1/13/818


12.12.2016




8.12.2016


CONTROLOC Control


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


EU/1/09/515


12.12.2016




8.12.2016


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


12.12.2016




8.12.2016


DuoPlavin


Sanofi Clir SNC
54 rue La Boétie, F-75008 Paris, France


EU/1/10/619


12.12.2016




8.12.2016


Eperzan


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/13/908


14.12.2016




8.12.2016


GILENYA


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


EU/1/11/677


12.12.2016




8.12.2016


Holoclar


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


EU/1/14/987


12.12.2016




8.12.2016


Icandra


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


EU/1/08/484


12.12.2016




8.12.2016


Lamivudine/Zidovudine Teva


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


EU/1/10/663


12.12.2016




8.12.2016


Mimpara


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


EU/1/04/292


5.12.2016




8.12.2016


Otezla


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


EU/1/14/981


12.12.2016




8.12.2016


PANTOZOL Control


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


EU/1/09/517


12.12.2016




8.12.2016


SOMAC Control


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


EU/1/09/516


12.12.2016




8.12.2016


Voriconazole Accord


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


EU/1/13/835


12.12.2016




8.12.2016


Zebinix


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


EU/1/09/514


12.12.2016




8.12.2016


Zoledronic acid Actavis


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


EU/1/12/759


12.12.2016




9.12.2016


Ecansya


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


EU/1/12/763


12.12.2016




12.12.2016


Accofil


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


EU/1/14/946


14.12.2016




12.12.2016


Aldara


Meda AB
Pipers väg 2A, SE-170 73 Solna, Sverige


EU/1/98/080


14.12.2016




12.12.2016


Aripiprazole Accord


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


EU/1/15/1045


14.12.2016




12.12.2016


Colobreathe


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


EU/1/11/747


14.12.2016




12.12.2016


Cometriq


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


EU/1/13/890


14.12.2016




12.12.2016


Competact


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


EU/1/06/354


14.12.2016




12.12.2016


Crixivan


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


EU/1/96/024


14.12.2016




12.12.2016


Docetaxel Kabi


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


EU/1/12/770


15.12.2016




12.12.2016


Ebymect


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/15/1051


14.12.2016




12.12.2016


Efficib


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


EU/1/08/457


14.12.2016




12.12.2016


Eucreas


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


EU/1/07/425


14.12.2016




12.12.2016


Flebogamma DIF


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


EU/1/07/404


14.12.2016




12.12.2016


Glubrava


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


EU/1/07/421


14.12.2016




12.12.2016


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


14.12.2016




12.12.2016


Inflectra


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


EU/1/13/854


14.12.2016




12.12.2016


Janumet


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


EU/1/08/455


14.12.2016




12.12.2016


Jentadueto


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


EU/1/12/780


14.12.2016




12.12.2016


Komboglyze


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/731


14.12.2016




12.12.2016


Kyprolis


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


EU/1/15/1060


14.12.2016




12.12.2016


Lynparza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/14/959


14.12.2016




12.12.2016


Mysimba


Orexigen Therapeutics Ireland Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/14/988


14.12.2016




12.12.2016


Nimenrix


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


EU/1/12/767


14.12.2016




12.12.2016


NovoMix


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


EU/1/00/142


14.12.2016




12.12.2016


Optaflu


Seqirus GmbH
Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland


EU/1/07/394


14.12.2016




12.12.2016


Orbactiv


The Medicines Company UK Ltd
115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom


EU/1/15/989


14.12.2016




12.12.2016


Pregabalin Accord


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


EU/1/15/1027


14.12.2016




12.12.2016


Ristfor


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


EU/1/10/620


14.12.2016




12.12.2016


Synjardy


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


EU/1/15/1003


14.12.2016




12.12.2016


TAGRISSO


AstraZeneca AB
Gärtunavägen, SE-151 85 Södertälje, Sverige


EU/1/16/1086


14.12.2016




12.12.2016


Trulicity


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


EU/1/14/956


14.12.2016




12.12.2016


Velmetia


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


EU/1/08/456


14.12.2016




12.12.2016


Vimpat


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/08/470


14.12.2016




12.12.2016


Vipdomet


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


EU/1/13/843


14.12.2016




12.12.2016


Vokanamet


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


EU/1/14/918


14.12.2016




12.12.2016


Xigduo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/13/900


14.12.2016




12.12.2016


Xtandi


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


EU/1/13/846


14.12.2016




12.12.2016


Zomarist


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


EU/1/08/483


14.12.2016




13.12.2016


GONAL-f


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


EU/1/95/001


16.12.2016




16.12.2016


Atripla


Bristol-Myers Squibb and Gilead Sciences Limited
IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland


EU/1/07/430


21.12.2016




16.12.2016


Caprelsa


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


EU/1/11/749


20.12.2016




16.12.2016


Kentera


Nicobrand Limited
189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom


EU/1/03/270


20.12.2016




16.12.2016


Levemir


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


EU/1/04/278


20.12.2016




16.12.2016


Mixtard


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


EU/1/02/231


20.12.2016




16.12.2016


Pemetrexed Lilly


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


EU/1/15/1034


20.12.2016




16.12.2016


Pramipexole Teva


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


EU/1/08/490


20.12.2016




16.12.2016


RotaTeq


Sanofi Pasteur MSD SAS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/348


20.12.2016




16.12.2016


Sebivo


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


EU/1/07/388


20.12.2016




19.12.2016


Entyvio


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


EU/1/14/923


21.12.2016




19.12.2016


Pemetrexed Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1037


21.12.2016




19.12.2016


Tractocile


Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark


EU/1/99/124


21.12.2016




19.12.2016


Visudyne


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


EU/1/00/140


21.12.2016




23.12.2016


Duloxetine Mylan


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


EU/1/15/1010


5.1.2017




23.12.2016


Fareston


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/96/004


4.1.2017




23.12.2016


Invirase


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


EU/1/96/026


4.1.2017




23.12.2016


Mepact


Takeda France SAS
Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France


EU/1/08/502


4.1.2017




23.12.2016


Orkambi


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/15/1059


4.1.2017




23.12.2016


Raplixa


Mallinckrodt Pharmaceuticals Ireland Limited
College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland


EU/1/14/985


4.1.2017




23.12.2016


Sirturo


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


EU/1/13/901


4.1.2017




—   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




16.12.2016


Budesonide/Formoterol Teva


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


EU/1/14/948


20.12.2016




16.12.2016


Budesonide/Formoterol Teva Pharma B.V.


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


EU/1/14/950


20.12.2016




—   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




13.12.2016


Cepedex


dexmedetomidine


CP Pharma Handelsgesellschaft mbH
Ostlandring 13, D-31303 Burgdorf, Deutschland


EU/2/16/200


Solution for injection


QN05CM18


15.12.2016




13.12.2016


Halagon


halofuginone


Emdoka bvba
J. Lijsenstraat 16, B-2321 Hoogstraten, België


EU/2/16/201


Oral solution


QP51AX08


15.12.2016




—   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




13.12.2016


Parvoduk


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


EU/2/14/162


15.12.2016




13.12.2016


Zulvac 1 + 8 Bovis


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


EU/2/12/139


15.12.2016




14.12.2016


Activyl Tick Plus


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


EU/2/11/137


16.12.2016




14.12.2016


Porcilis PCV M Hyo


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


EU/2/14/175


16.12.2016




14.12.2016


Versican Plus DHPPi


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


EU/2/14/169


16.12.2016




14.12.2016


Versican Plus DHPPi/L4


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


EU/2/14/164


16.12.2016




14.12.2016


Versican Plus DHPPi/L4R


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


EU/2/14/163


16.12.2016




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.