Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2018 to 31 March 2018 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2018-04-27
Institutions: European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_2018150EN.01000101.xml










27.4.2018   


EN


Official Journal of the European Union


C 150/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2018 to 31 March 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 150/01)






—



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




21.3.2018


Shingrix


herpes zoster vaccine (recombinant, adjuvanted)


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


EU/1/18/1272


Powder and suspension for suspension for injection


J07BK03


23.3.2018




21.3.2018


Steglatro


ertugliflozin


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


EU/1/18/1267


Film-coated tablet


A10BK04


23.3.2018




22.3.2018


Lokelma


sodium zirconium cyclosilicate


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/17/1173


Powder for oral suspension


V03AE10


26.3.2018




23.3.2018


Alofisel


Darvadstrocel


TiGenix S.A.U.
C/Marconi 1, Parque Tecnológico de Madrid, 28760 Tres Cantos, Madrid, España


EU/1/17/1261


Suspension for injection


L04


27.3.2018




23.3.2018


Lamzede


velmanase alfa


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


EU/1/17/1258


Powder for solution for infusion


A16AB


27.3.2018




23.3.2018


Segluromet


ertugliflozin / metformin hydrochloride


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


EU/1/18/1265


Film-coated tablet


A10BD23


27.3.2018




23.3.2018


Semglee


Insulin glargine


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


EU/1/18/1270


Solution for injection in pre-filled pen


A10AE04


27.3.2018




23.3.2018


Steglujan


ertugliflozin / sitagliptin


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


EU/1/18/1266


Film-coated tablet


A10BD24


27.3.2018










—



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




1.3.2018


Ameluz


Biofrontera Bioscience GmbH
Hemmelrather Weg 201, 51377 Leverkusen, Deutschland


EU/1/11/740


5.3.2018




1.3.2018


BiResp Spiromax


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


EU/1/14/921


5.3.2018




1.3.2018


Galvus


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


EU/1/07/414


5.3.2018




1.3.2018


GONAL-f


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


EU/1/95/001


5.3.2018




1.3.2018


IDELVION


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/16/1095


5.3.2018




1.3.2018


Insulatard


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


EU/1/02/233


5.3.2018




1.3.2018


Jalra


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


EU/1/08/485


5.3.2018




1.3.2018


Mixtard


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


EU/1/02/231


5.3.2018




1.3.2018


Neparvis


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


EU/1/16/1103


5.3.2018




1.3.2018


Protaphane


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


EU/1/02/234


5.3.2018




1.3.2018


Xeplion


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


EU/1/11/672


5.3.2018




1.3.2018


Xiliarx


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


EU/1/08/486


5.3.2018




5.3.2018


Adenuric


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


EU/1/08/447


7.3.2018




5.3.2018


CellCept


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


EU/1/96/005


7.3.2018




5.3.2018


Epivir


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


EU/1/96/015


7.3.2018




5.3.2018


Hizentra


CSL Behring GmbH
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland


EU/1/11/687


7.3.2018




5.3.2018


Myclausen


Passauer Pharma GmbH
Eiderstedter Weg 3, 14129 Berlin, Deutschland


EU/1/10/647


8.3.2018




5.3.2018


Mycophenolate mofetil Teva


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


EU/1/07/439


7.3.2018




5.3.2018


Myfenax


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


EU/1/07/438


7.3.2018




5.3.2018


Relvar Ellipta


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


EU/1/13/886


7.3.2018




5.3.2018


Sirturo


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


EU/1/13/901


7.3.2018




5.3.2018


Terrosa


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


EU/1/16/1159


7.3.2018




5.3.2018


Viekirax


AbbVie Ltd
Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom


EU/1/14/982


7.3.2018




5.3.2018


Zydelig


Gilead Sciences International Limited
Flowers Building, Granta Park, Abington, Cambridge CB21 6GT United Kingdom


EU/1/14/938


7.3.2018




7.3.2018


Aclasta


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


EU/1/05/308


9.3.2018




7.3.2018


Adempas


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/907


9.3.2018




7.3.2018


Kisplyx


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


EU/1/16/1128


9.3.2018




7.3.2018


Levetiracetam Actavis


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


EU/1/11/713


9.3.2018




7.3.2018


Litak


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


EU/1/04/275


9.3.2018




7.3.2018


Lonsurf


Les Laboratoires Servier
50 rue Carnot, 92284 Suresnes CEDEX, France


EU/1/16/1096


9.3.2018




7.3.2018


Pregabalin Pfizer


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


EU/1/14/916


9.3.2018




7.3.2018


PritorPlus


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/02/215


9.3.2018




7.3.2018


Raplixa


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


EU/1/14/985


9.3.2018




7.3.2018


Revinty Ellipta


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


EU/1/14/929


9.3.2018




7.3.2018


Tecentriq


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


EU/1/17/1220


9.3.2018




12.3.2018


CellCept


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


EU/1/96/005


14.3.2018




12.3.2018


DuoResp Spiromax


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


EU/1/14/920


14.3.2018




12.3.2018


Latuda


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


EU/1/14/913


14.3.2018




12.3.2018


MicardisPlus


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


EU/1/02/213


14.3.2018




12.3.2018


Neuraceq


Piramal Imaging Limited
Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom


EU/1/13/906


14.3.2018




12.3.2018


Oprymea


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


EU/1/08/469


15.3.2018




12.3.2018


Trajenta


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


EU/1/11/707


14.3.2018




15.3.2018


Alecensa


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


EU/1/16/1169


19.3.2018




15.3.2018


Erivedge


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


EU/1/13/848


19.3.2018




15.3.2018


Humira


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


EU/1/03/256


19.3.2018




15.3.2018


NeoRecormon


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


EU/1/97/031


19.3.2018




15.3.2018


Pegasys


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


EU/1/02/221


19.3.2018




15.3.2018


Vaxelis


MCM Vaccine B.V.
Robert Boyleweg 4, 2333 CG Leiden, Nederland


EU/1/15/1079


19.3.2018




16.3.2018


Aripiprazole Sandoz


Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl, Österreich


EU/1/15/1029


20.3.2018




16.3.2018


Avastin


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


EU/1/04/300


20.3.2018




16.3.2018


Cetrotide


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


EU/1/99/100


22.3.2018




16.3.2018


Cotellic


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


EU/1/15/1048


20.3.2018




16.3.2018


Glyxambi


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


EU/1/16/1146


20.3.2018




16.3.2018


Herceptin


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


EU/1/00/145


20.3.2018




16.3.2018


IDflu


Sanofi Pasteur SA
2 avenue Pont Pasteur, 69007 Lyon, France


EU/1/08/507


20.3.2018




16.3.2018


Integrilin


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


EU/1/99/109


20.3.2018




16.3.2018


Jentadueto


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


EU/1/12/780


20.3.2018




16.3.2018


Kadcyla


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


EU/1/13/885


20.3.2018




16.3.2018


Kinzalkomb


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/02/214


20.3.2018




16.3.2018


Mabthera


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


EU/1/98/067


21.3.2018




16.3.2018


Mircera


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


EU/1/07/400


20.3.2018




16.3.2018


Silgard


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


EU/1/06/358


21.3.2018




16.3.2018


Vaniqa


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


EU/1/01/173


20.3.2018




16.3.2018


Xeloda


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


EU/1/00/163


20.3.2018




16.3.2018


Zomarist


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


EU/1/08/483


20.3.2018




19.3.2018


Xofigo


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/873


21.3.2018




20.3.2018


Invirase


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


EU/1/96/026


22.3.2018




21.3.2018


Aripiprazole Zentiva


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


EU/1/15/1009


23.3.2018




21.3.2018


Faslodex


AstraZeneca AB
151 85 Södertälje, Sverige


EU/1/03/269


23.3.2018




21.3.2018


OCALIVA


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


EU/1/16/1139


23.3.2018




21.3.2018


PHEBURANE


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


EU/1/13/822


23.3.2018




21.3.2018


Pixuvri


CTI Life Sciences Ltd
Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


23.3.2018




21.3.2018


Vibativ


Theravance Biopharma Ireland Limited
Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland


EU/1/11/705


23.3.2018




23.3.2018


Atripla


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


EU/1/07/430


27.3.2018




23.3.2018


Blincyto


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


EU/1/15/1047


27.3.2018




23.3.2018


Feraccru


Shield TX (UK) Limited
Gateshead Quays, NE8 3DF, United Kingdom


EU/1/15/1075


27.3.2018




23.3.2018


Invirase


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


EU/1/96/026


27.3.2018




23.3.2018


Isentress


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


EU/1/07/436


27.3.2018




23.3.2018


KEYTRUDA


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


EU/1/15/1024


27.3.2018




23.3.2018


Nuwiq


Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm, Sverige


EU/1/14/936


27.3.2018




23.3.2018


Ocrevus


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


EU/1/17/1231


27.3.2018




23.3.2018


Opdivo


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


EU/1/15/1014


27.3.2018




23.3.2018


Perjeta


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


EU/1/13/813


27.3.2018




23.3.2018


Pixuvri


CTI Life Sciences Ltd
Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


27.3.2018




23.3.2018


Torisel


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


EU/1/07/424


27.3.2018




23.3.2018


Translarna


PTC Therapeutics International Limited
5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland


EU/1/13/902


27.3.2018




27.3.2018


EndolucinBeta


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


EU/1/16/1105


29.3.2018




27.3.2018


Ganfort


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


EU/1/06/340


29.3.2018




27.3.2018


Xgeva


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


EU/1/11/703


29.3.2018










—



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




5.3.2018


OLYSIO


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


EU/1/14/924


7.3.2018




19.3.2018


IDflu


Sanofi Pasteur SA
2 avenue Pont Pasteur, 69007 Lyon, France


EU/1/08/507


21.3.2018




23.3.2018


Vibativ


Theravance Biopharma Ireland Limited
Connaught House 1, Burlington Road, Fourth Floor, D04 C5Y6 Dublin 4, Ireland


EU/1/11/705


27.3.2018




27.3.2018


Raplixa


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


EU/1/14/985


29.3.2018




27.3.2018


Zinbryta


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


EU/1/16/1107


29.3.2018










—



Suspension of a marketing authorization (Article 20 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




8.3.2018


Zinbryta


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


EU/1/16/1107


12.3.2018










—



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




19.3.2018


Bravecto


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


EU/2/13/158


21.3.2018




19.3.2018


Metacam


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


EU/2/97/004


21.3.2018




19.3.2018


Porcilis PCV ID


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


EU/2/15/187


21.3.2018




20.3.2018


ECOPORC SHIGA


IDT Biologika GmbH
Am Pharmapark, 06861 Dessau-Rosslau, Deutschland


EU/2/13/149


22.3.2018




20.3.2018


Oncept IL-2


Merial
29 avenue Tony Garnier, 69007 Lyon, France


EU/2/13/150


22.3.2018




20.3.2018


Panacur AquaSol


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


EU/2/11/135


22.3.2018




22.3.2018


Draxxin


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


EU/2/03/041


26.3.2018




22.3.2018


ERAVAC


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


EU/2/16/199


26.3.2018




22.3.2018


Palladia


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


EU/2/09/100


26.3.2018




22.3.2018


Suvaxyn CSF Marker


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


EU/2/14/179


26.3.2018




22.3.2018


Suvaxyn PCV


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


EU/2/09/099


26.3.2018




27.3.2018


Versican Plus DHPPi


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


EU/2/14/169


29.3.2018




27.3.2018


Versican Plus DHPPi/L4


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


EU/2/14/164


29.3.2018




27.3.2018


Versican Plus DHPPi/L4R


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


EU/2/14/163


29.3.2018




27.3.2018


Zulvac 1+8 Bovis


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


EU/2/12/139


29.3.2018




27.3.2018


Zulvac 1+8 Ovis


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


EU/2/11/120


29.3.2018




27.3.2018


Zulvac SBV


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


EU/2/14/178


29.3.2018




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.