Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2018 to 30 November 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-12-27
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018465EN.01000101.xml










27.12.2018   


EN


Official Journal of the European Union


C 465/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2018 to 30 November 2018
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2018/C 465/01)






—



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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




14.11.2018


Emgality


galcanezumab


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


EU/1/18/1330


Solution for injection


N02CX08


16.11.2018




20.11.2018


Apealea


paclitaxel


Oasmia Pharmaceutical AB
Vallongatan 1, 75228 Uppsala, Sverige


EU/1/18/1292


Powder for solution for infusion


L01CD01


22.11.2018




20.11.2018


Buvidal


buprenorphine


Camurus AB
Ideon Science Park, 223 70 Lund, Sverige


EU/1/18/1336


Prolonged-release solution for injection


N07BC01


22.11.2018




20.11.2018


Fulphila


pegfilgrastim


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


EU/1/18/1329


Solution for injection


L03AA13


22.11.2018




20.11.2018


Pelmeg


pegfilgrastim


Cinfa Biotech S.L.
Travesía de Roncesvalles 1, 31699 Olloki (Navarra), España


EU/1/18/1328


Solution for injection


L03AA13


22.11.2018




20.11.2018


Vabomere


meropenem/vaborbactam


Rempex London Limited
115L Milton Park, Abingdon, Oxfordshire, OX14 4SA United Kingdom


EU/1/18/1334


Powder for concentrate for solution for infusion


J01DH52


22.11.2018




20.11.2018


Venclyxto


venetoclax


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/16/1138


Film-coated tablet


L01XX52


22.11.2018




22.11.2018


Alunbrig


brigatinib


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


EU/1/18/1264


Film-coated tablet


L01XE43


26.11.2018




22.11.2018


Delstrigo


doravirine/lamivudine/tenofovir disoproxil


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1333


Film-coated tablet


J05AG24


26.11.2018




22.11.2018


Jivi


damoctocog alfa pegol


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/18/1324


Powder and solvent for solution for injection


B02BD02


26.11.2018




22.11.2018


Luxturna


voretigene neparvovec


Spark Therapeutics Ireland Ltd
Studio G3,The Tower, Trinity Technology & Enterprise Campus, Pearse Street, Dublin 2, Ireland


EU/1/18/1331


Concentrate and solvent for solution for injection


Pending


5.12.2018




22.11.2018


Pifeltro


doravirine


Merck Sharp & Dohme B.V.
Waarderweg 39, 2031 BN Haarlem, Nederland


EU/1/18/1332


Film-coated tablet


J05AG06


27.11.2018




22.11.2018


Poteligeo


Mogamulizumab


Kyowa Kirin Holdings B.V.
Bloemlaan 2, 2132 NP Hoofddorp, Nederland


EU/1/18/1335


Concentrate for solution for infusion


L01XC25


26.11.2018




22.11.2018


TAKHZYRO


lanadelumab


Shire Pharmaceuticals Ireland Limited
Block 2 & 3 Miesian Plaza, 50 — 58 Baggot Street Lower, Dublin 2, IRELAND


EU/1/18/1340


Solution for injection


B06AC05


26.11.2018




22.11.2018


Ziextenzo


pegfilgrastim


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/18/1327


Solution for injection


L03AA13


26.11.2018










—



Modification 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


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




8.11.2018


Benepali


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/15/1074


13.11.2018




8.11.2018


Benepali


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/15/1074


15.11.2018




8.11.2018


Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva


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


EU/1/17/1210


12.11.2018




8.11.2018


Flixabi


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/16/1106


15.11.2018




8.11.2018


Irbesartan HCT Zentiva


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


EU/1/06/377


12.11.2018




8.11.2018


Neupro


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


EU/1/05/331


12.11.2018




8.11.2018


Ontruzant


Samsung Bioepis NL B.V.
Olof Palmestraat 10, 2616 LR Delft, Nederland


EU/1/17/1241


16.11.2018




8.11.2018


Ruconest


Pharming Group N.V.
Darwinweg 24, 2333 CR Leiden, Nederland


EU/1/10/641


12.11.2018




8.11.2018


Spinraza


Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland


EU/1/17/1188


12.11.2018




8.11.2018


Tracleer


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


EU/1/02/220


12.11.2018




8.11.2018


Xeljanz


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/17/1178


12.11.2018




12.11.2018


Bemfola


Gedeon Richter Plc.
Gyömrői út 19-21., 1103 Budapest, Magyarország


EU/1/13/909


14.11.2018




12.11.2018


CABOMETYX


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


EU/1/16/1136


14.11.2018




12.11.2018


Clopidogrel ratiopharm


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


EU/1/14/975


14.11.2018




12.11.2018


Desloratadine ratiopharm


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


EU/1/11/746


14.11.2018




12.11.2018


Ebymect


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1051


14.11.2018




12.11.2018


Edistride


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/15/1052


14.11.2018




12.11.2018


Exviera


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/983


14.11.2018




12.11.2018


Forxiga


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/12/795


14.11.2018




12.11.2018


Jinarc


Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland


EU/1/15/1000


14.11.2018




12.11.2018


Laventair Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/899


14.11.2018




12.11.2018


Olanzapine Mylan


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


EU/1/08/475


7.12.2018




12.11.2018


Xigduo


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/900


14.11.2018




14.11.2018


Benlysta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/11/700


16.11.2018




14.11.2018


Daptomycin Hospira


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


EU/1/17/1175


16.11.2018




14.11.2018


Incruse Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/922


16.11.2018




14.11.2018


Izba


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/13/905


16.11.2018




14.11.2018


Latuda


Aziende Chimiche Riunite Angelini Francesco — A.C.R.A.F. S.p.A.
Viale Amelia 70, 00181 Roma, Italia


EU/1/14/913


16.11.2018




14.11.2018


Laventair Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/899


16.11.2018




14.11.2018


Tecfidera


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


EU/1/13/837


16.11.2018




20.11.2018


Brineura


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/17/1192


22.11.2018




20.11.2018


Brintellix


H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Danmark


EU/1/13/891


22.11.2018




20.11.2018


Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/16/1151


22.11.2018




20.11.2018


Fluenz Tetra


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/887


22.11.2018




20.11.2018


Incruse Ellipta


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/14/922


22.11.2018




20.11.2018


Levetiracetam Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/13/889


22.11.2018




20.11.2018


Neuraceq


Life Radiopharma Berlin GmbH
Max-Planck-Straße 4, 12489 Berlin, Deutschland


EU/1/13/906


22.11.2018




20.11.2018


NovoSeven


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


EU/1/96/006


22.11.2018




20.11.2018


Orfadin


Swedish Orphan Biovitrum International AB
112 76 Stockholm, Sverige


EU/1/04/303


23.11.2018




20.11.2018


Ozurdex


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/10/638


22.11.2018




20.11.2018


PREZISTA


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


EU/1/06/380


22.11.2018




20.11.2018


Rapiscan


GE Healthcare AS
Nycoveien 1, 0485, Oslo, Norge


EU/1/10/643


22.11.2018




20.11.2018


Rezolsta


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


EU/1/14/967


22.11.2018




20.11.2018


Selincro


H. Lundbeck A/S
Ottiliavej 9, 2500 Valby, Danmark


EU/1/12/815


22.11.2018




20.11.2018


Symtuza


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


EU/1/17/1225


22.11.2018




20.11.2018


Zoledronic acid Accord


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


EU/1/13/834


22.11.2018




22.11.2018


Atripla


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


EU/1/07/430


26.11.2018




22.11.2018


Bexsero


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


EU/1/12/812


26.11.2018




22.11.2018


Docetaxel Zentiva


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


EU/1/07/384


26.11.2018




22.11.2018


Efient


Daiichi Sankyo Europe GmbH
Zielstattstraße 48, 81379 München, Deutschland


EU/1/08/503


26.11.2018




22.11.2018


Erivedge


Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland


EU/1/13/848


26.11.2018




22.11.2018


GILENYA


Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland


EU/1/11/677


28.11.2018




22.11.2018


Inlyta


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/12/777


26.11.2018




22.11.2018


Ixiaro


Valneva Austria GmbH
Campus Vienna Biocenter 3, 1030 Wien, Österreich


EU/1/08/501


26.11.2018




22.11.2018


Kalydeco


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/12/782


26.11.2018




22.11.2018


Kentera


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


EU/1/03/270


26.11.2018




22.11.2018


Kyprolis


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


EU/1/15/1060


26.11.2018




22.11.2018


Levetiracetam Hospira


Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/Pleinlaan 17, 1050 Brussel, België


EU/1/13/889


26.11.2018




22.11.2018


Mirvaso


Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France


EU/1/13/904


26.11.2018




22.11.2018


Nyxoid


Mundipharma Corporation (Ireland) Limited
Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland


EU/1/17/1238


26.11.2018




22.11.2018


Ranexa


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


EU/1/08/462


26.11.2018




22.11.2018


Soliris


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


EU/1/07/393


27.11.2018




22.11.2018


Synflorix


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


EU/1/09/508


26.11.2018




22.11.2018


Viekirax


AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland


EU/1/14/982


26.11.2018




22.11.2018


Wakix


Bioprojet Pharma
9 rue Rameau, 75002 Paris, France


EU/1/15/1068


26.11.2018




22.11.2018


Zinforo


Pfizer Ireland Pharmaceuticals
Operations Support Group, Ringaskiddy, County Cork, Ireland


EU/1/12/785


26.11.2018




26.11.2018


alli


GlaxoSmithKline Dungarvan Limited
Knockbrack, Dungarvan, Co. Waterford, Ireland


EU/1/07/401


29.11.2018




26.11.2018


Anoro Ellipta


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


EU/1/14/898


28.11.2018




26.11.2018


Darunavir Krka d.d.


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


EU/1/17/1248


28.11.2018




26.11.2018


Docetaxel Zentiva


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


EU/1/07/384


28.11.2018




26.11.2018


Kalydeco


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/12/782


28.11.2018




26.11.2018


Leflunomide ratiopharm


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


EU/1/10/654


28.11.2018




26.11.2018


Orkambi


Vertex Pharmaceuticals (Ireland) Limited
28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland


EU/1/15/1059


28.11.2018




26.11.2018


PHEBURANE


Eurocept International BV
Trapgans 5, 1244 RL Ankeveen, Nederland


EU/1/13/822


28.11.2018




26.11.2018


Zeffix


GlaxoSmithKline (Ireland) Limited
12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/99/114


28.11.2018




28.11.2018


AMGEVITA


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


EU/1/16/1164


30.11.2018




28.11.2018


Pregabalin Zentiva k.s


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


EU/1/16/1166


30.11.2018










—



Withdrawal of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




12.11.2018


Eperzan


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


EU/1/13/908


14.11.2018










—



Modification of a marketing authorisation (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 authorisation


Number of the entry in the Community Register


Date of notification




19.11.2018


Osurnia


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/14/170


21.11.2018




19.11.2018


Rheumocam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/07/078


21.11.2018




26.11.2018


Econor


Elanco GmbH
Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland


EU/2/98/010


28.11.2018




26.11.2018


Inflacam


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/11/134


29.11.2018




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.