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Document 52018XC1227(03)

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)

OJ C 465, 27.12.2018, p. 1–9 (BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

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.


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