Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2018 to 30 September 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-10-26
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018390EN.01000101.xml










26.10.2018   


EN


Official Journal of the European Union


C 390/1






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2018 to 30 September 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 390/01)






—



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




17.9.2018


Hulio


adalimumab


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


EU/1/18/1319


Solution for injection


L04AB04


19.9.2018




17.9.2018


Ilumetri


tildrakizumab


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


EU/1/18/1323


Solution for injection


L04AC17


19.9.2018




20.9.2018


Braftovi


encorafenib


Pierre Fabre Médicament
45, place Abel Gance, 92100 Boulogne-Billancourt, France


EU/1/18/1314


Capsule, hard


Pending


24.9.2018




20.9.2018


Deferiprone Lipomed


Deferiprone


Lipomed GmbH
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland


EU/1/18/1310


Film-coated tablet


V03AC02


24.9.2018




20.9.2018


Kigabeq


vigabatrin


ORPHELIA Pharma SAS
85 boulevard Saint-Michel, 75005 Paris, France


EU/1/18/1302


Soluble tablet


N03AG04


24.9.2018




20.9.2018


Lenalidomide Accord


lenalidomide


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


EU/1/18/1316


Capsule, hard


L04AX04


24.9.2018




20.9.2018


Mektovi


binimetinib


Pierre Fabre Médicament
45, place Abel Gance, 92100 Boulogne-Billancourt, France


EU/1/18/1315


Film-coated tablet


L01XE41


24.9.2018




20.9.2018


Slenyto


melatonin


RAD Neurim Pharmaceuticals EEC Limited
5th Floor, Thames Tower, Station Road, Reading, Berkshire RG1 1LX, United Kingdom


EU/1/18/1318


Prolonged-release tablet


N05CH01


25.9.2018




20.9.2018


Xerava


Eravacycline


Tetraphase Pharmaceuticals Ireland Limited
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland


EU/1/18/1312


Powder for concentrate for solution for infusion


J01AA13


24.9.2018




21.9.2018


Imfinzi


durvalumab


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/18/1322


Concentrate for solution for infusion


L01XC


25.9.2018




21.9.2018


Pelgraz


pegfilgrastim


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


EU/1/18/1313


Solution for injection in a pre-filled syringe


L03AA13


25.9.2018




21.9.2018


Udenyca


pegfilgrastim


ERA Consulting GmbH
Lange Straße 70, 29664 Walsrode, Deutschland


EU/1/18/1303


Solution for injection


L03AA13


25.9.2018




27.9.2018


Gefitinib Mylan


gefitinib


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


EU/1/18/1321


Film-coated tablet


L01XE02


1.10.2018




27.9.2018


Verzenios


abemaciclib


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


EU/1/18/1307


Film-coated tablet


L01XE50


1.10.2018










—



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




4.9.2018


Invokana


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


EU/1/13/884


6.9.2018




4.9.2018


KEYTRUDA


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


EU/1/15/1024


6.9.2018




4.9.2018


Olumiant


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


EU/1/16/1170


7.9.2018




6.9.2018


Akynzeo


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


EU/1/15/1001


10.9.2018




6.9.2018


Alkindi


Diurnal Europe B.V.
Jachthavenweg 109 H, 1081 KM Amsterdam, Nederland


EU/1/17/1260


10.9.2018




6.9.2018


Retacrit


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


EU/1/07/431


10.9.2018




6.9.2018


Silapo


STADA Arzneimittel AG
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland


EU/1/07/432


10.9.2018




6.9.2018


Venclyxto


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


EU/1/16/1138


10.9.2018




10.9.2018


ADCETRIS


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


EU/1/12/794


12.9.2018




10.9.2018


Memantine Mylan


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


EU/1/13/827


19.9.2018




10.9.2018


Pregabalin Mylan


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


EU/1/15/997


19.9.2018




12.9.2018


Tegsedi


Akcea Therapeutics UK Ltd
Office 32, 19-21 Crawford Street, London, W1H 1PJ, United Kingdom


EU/1/18/1296


14.9.2018




17.9.2018


CRYSVITA


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


EU/1/17/1262


19.9.2018




17.9.2018


Fortacin


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/13/881


19.9.2018




17.9.2018


Inhixa


Techdow Europe AB
Kåbovägen 32, 75236 Uppsala, Sverige


EU/1/16/1132


24.9.2018




17.9.2018


Kadcyla


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


EU/1/13/885


19.9.2018




17.9.2018


Lartruvo


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


EU/1/16/1143


19.9.2018




17.9.2018


Ninlaro


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


EU/1/16/1094


19.9.2018




17.9.2018


Pregabalin Mylan Pharma


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


EU/1/15/998


19.9.2018




17.9.2018


Sovaldi


Gilead Sciences Ireland UC
Carrigtohill, County Cork, T45 DP77, Ireland


EU/1/13/894


19.9.2018




17.9.2018


Stelara


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


EU/1/08/494


19.9.2018




17.9.2018


Targretin


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/01/178


19.9.2018




20.9.2018


Atazanavir Mylan


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


EU/1/16/1091


24.9.2018




20.9.2018


Blitzima


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/17/1205


24.9.2018




20.9.2018


Cinqaero


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


EU/1/16/1125


24.9.2018




20.9.2018


Cosentyx


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


EU/1/14/980


24.9.2018




20.9.2018


Cyramza


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


EU/1/14/957


24.9.2018




20.9.2018


Diacomit


Biocodex
7 avenue Gallieni, 94250 Gentilly, France


EU/1/06/367


24.9.2018




20.9.2018


EndolucinBeta


ITG Isotope Technologies Garching GmbH
Lichtenbergstraße 1, 85748 Garching, Deutschland


EU/1/16/1105


24.9.2018




20.9.2018


Iclusig


Incyte Biosciences Distribution B.V.
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland


EU/1/13/839


24.9.2018




20.9.2018


INCRELEX


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


EU/1/07/402


24.9.2018




20.9.2018


Kanuma


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


EU/1/15/1033


24.9.2018




20.9.2018


Karvezide


Sanofi-Aventis groupe
54 rue La Boétie, 75008 Paris, France


EU/1/98/085


24.9.2018




20.9.2018


Lumark


IDB Holland B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


24.9.2018




20.9.2018


Neofordex


Laboratoires CTRS
63 rue de l’Est, 92100 Boulogne-Billancourt, France


EU/1/15/1053


24.9.2018




20.9.2018


NeuroBloc


Sloan Pharma S.a.r.l.
33 Rue de Puits Romain, 8070 Bertrange, Luxembourg


EU/1/00/166


24.9.2018




20.9.2018


Nitisinone MDK


MendeliKABS Europe Limited
The Light Box, 111 Power Rd, Unit G. 07, Chiswick, London, W4 5PY, United Kingdom


EU/1/17/1217


24.9.2018




20.9.2018


Opdivo


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


EU/1/15/1014


24.9.2018




20.9.2018


Ovitrelle


Merck Europe B.V.
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland


EU/1/00/165


24.9.2018




20.9.2018


Rasilez


Noden Pharma DAC
D’Olier Chambers, 16A D’Olier Street, Dublin 2, Ireland


EU/1/07/405


24.9.2018




20.9.2018


Renvela


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


EU/1/09/521


24.9.2018




20.9.2018


Rixathon


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/17/1185


24.9.2018




20.9.2018


Ryzodeg


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


EU/1/12/806


24.9.2018




20.9.2018


Sevelamer carbonate Zentiva


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


EU/1/14/952


24.9.2018




20.9.2018


Tecfidera


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


EU/1/13/837


24.9.2018




20.9.2018


Topotecan Hospira


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


EU/1/10/633


24.9.2018




20.9.2018


Tresiba


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


EU/1/12/807


24.9.2018




20.9.2018


Zoledronic acid Hospira


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


EU/1/12/800


24.9.2018




21.9.2018


Brilique


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/10/655


25.9.2018




21.9.2018


Fycompa


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/12/776


25.9.2018




21.9.2018


Inovelon


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/06/378


25.9.2018




21.9.2018


Opsumit


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


EU/1/13/893


25.9.2018




21.9.2018


Tivicay


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/13/892


25.9.2018




21.9.2018


Voriconazole Hikma


Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal


EU/1/15/1004


25.9.2018




21.9.2018


Zonegran


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/04/307


25.9.2018




27.9.2018


BeneFIX


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


EU/1/97/047


1.10.2018




27.9.2018


Ecalta


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


EU/1/07/416


1.10.2018




27.9.2018


Prevenar 13


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


EU/1/09/590


1.10.2018




27.9.2018


Trumenba


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


EU/1/17/1187


1.10.2018




27.9.2018


Vimizim


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland


EU/1/14/914


1.10.2018




28.9.2018


Celsentri


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/07/418


2.10.2018




28.9.2018


CoAprovel


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


EU/1/98/086


2.10.2018




28.9.2018


Docetaxel Teva


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


EU/1/09/611


2.10.2018




28.9.2018


Dynastat


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


EU/1/02/209


2.10.2018




28.9.2018


HALAVEN


Eisai GmbH
Lyoner Straße 36, 60528 Frankfurt am Main, Deutschland


EU/1/11/678


2.10.2018




28.9.2018


Imnovid


Celgene Europe B.V.
Winthontlaan 6 N, 3526 KV Utrecht, Nederland


EU/1/13/850


2.10.2018




28.9.2018


Imraldi


Samsung Bioepis UK Limited
5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom


EU/1/17/1216


2.10.2018




28.9.2018


IntronA


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


EU/1/99/127


2.10.2018




28.9.2018


Intuniv


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


EU/1/15/1040


2.10.2018




28.9.2018


Lamivudine Teva Pharma B.V.


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


EU/1/09/596


2.10.2018




28.9.2018


Metalyse


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


EU/1/00/169


2.10.2018




28.9.2018


Nexium Control


Pfizer Healthcare Ireland
9 Riverwalk National Digital Park, Citywest Business Campus, Dublin 24, D24 NT20, Ireland


EU/1/13/860


2.10.2018




28.9.2018


NexoBrid


MediWound Germany GmbH
Eisenstraße 5, 65428 Ruesselsheim, Deutschland


EU/1/12/803


2.10.2018




28.9.2018


PegIntron


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


EU/1/00/131


2.10.2018




28.9.2018


Pemetrexed Pfizer


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


EU/1/17/1183


2.10.2018




28.9.2018


Rebetol


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


EU/1/99/107


2.10.2018




28.9.2018


Retacrit


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


EU/1/07/431


2.10.2018




28.9.2018


Ritemvia


Celltrion Healthcare Hungary Kft.
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország


EU/1/17/1207


2.10.2018




28.9.2018


Telzir


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/04/282


2.10.2018




28.9.2018


Trizivir


ViiV Healthcare BV
Huis ter Heideweg 62, 3705 LZ Zeist, Nederland


EU/1/00/156


2.10.2018




28.9.2018


Uptravi


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


EU/1/15/1083


2.10.2018




28.9.2018


Vfend


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


EU/1/02/212


2.10.2018




28.9.2018


Vimizim


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland


EU/1/14/914


2.10.2018




28.9.2018


ViraferonPeg


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


EU/1/00/132


2.10.2018




28.9.2018


Xigduo


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/13/900


2.10.2018




28.9.2018


Xofigo


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/873


2.10.2018




28.9.2018


Zavesca


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


EU/1/02/238


2.10.2018




28.9.2018


Zoledronic acid Actavis


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


EU/1/12/759


2.10.2018




28.9.2018


Zoledronic acid Mylan


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


EU/1/12/786


2.10.2018




28.9.2018


Zoledronic acid Teva


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


EU/1/12/771


2.10.2018










—



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




27.9.2018


IONSYS


Incline Therapeutics Europe Ltd
21 St Thomas Street, Bristol BS1 6JS, United Kingdom


EU/1/15/1050


1.10.2018










—



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




24.9.2018


BROADLINE


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/157


26.9.2018




24.9.2018


Comfortis


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


EU/2/10/115


26.9.2018




24.9.2018


FORTEKOR PLUS


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


EU/2/15/185


26.9.2018




24.9.2018


Kexxtone


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


EU/2/12/145


26.9.2018




24.9.2018


Sileo


Orion Corporation
Orionintie 1, 02200 Espoo, Suomi


EU/2/15/181


26.9.2018




27.9.2018


Credelio


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


EU/2/17/206


1.10.2018




27.9.2018


Ingelvac PCV FLEX


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


EU/2/17/208


1.10.2018




27.9.2018


MS-H vaccine


Pharmsure Veterinary Products Europe Ltd
4 Ormond Quay Upper, DO7 PF53, Dublin, Ireland


EU/2/11/126


1.10.2018




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.