# C_2017367EN.01000101.xml

| 27.10.2017 | EN | Official Journal of the European Union | C 367/1 |
| --- | --- | --- | --- |

27.10.2017

EN

Official Journal of the European Union

C 367/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2017 to 30 September 2017

(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))

1

(2017/C 367/01)

| — | Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Issuing of a marketing authorisation

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.9.2017 | Cuprior | trientine | gmp-orphan SA
  Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France | EU/1/17/1199 | Tablet | A16AX12 | 7.9.2017 |
| 5.9.2017 | Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan | Efavirenz/emtricitabine/tenofovir disoproxil | Mylan S.A.S.
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/17/1222 | Film-coated tablet | J05AR06 | 7.9.2017 |
| 18.9.2017 | Bavencio | avelumab | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/17/1214 | Concentrate for solution for infusion | Pending | 20.9.2017 |
| 18.9.2017 | Entecavir Mylan | entecavir | Mylan S.A.S.
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/17/1227 | Film-coated tablet | J05AF10 | 20.9.2017 |
| 18.9.2017 | Lacosamide Accord | lacosamide | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/17/1230 | Film-coated tablet | N03AX18 | 20.9.2017 |
| 18.9.2017 | Rydapt | Midostaurin | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/17/1218 | Capsule, soft | L01XE39 | 20.9.2017 |
| 18.9.2017 | Xermelo | telotristat | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/17/1224 | Film-coated tablet | Pending | 20.9.2017 |
| 21.9.2017 | Symtuza | darunavir/cobicistat/emtricitabine/tenofovir alafenamide | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/17/1225 | Film-coated tablet | Pending | 25.9.2017 |
| 21.9.2017 | Tecentriq | atezolizumab | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/17/1220 | Concentrate for solution for infusion | Pending | 25.9.2017 |
| 26.9.2017 | Dupixent | dupilumab | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/17/1229 | Solution for injection | Pending | 28.9.2017 |
| 26.9.2017 | Entecavir Accord | entecavir | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/17/1211 | Film-coated tablet | J05AF10 | 28.9.2017 |
| 26.9.2017 | Lutathera | lutetium (177Lu) oxodotreotide | Advanced Accelerator Applications
  20 rue Diesel, F-01630 Saint-Genis-Pouilly, France | EU/1/17/1226 | Solution for infusion | V10XX04 | 28.9.2017 |

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

5.9.2017

Cuprior

trientine

gmp-orphan SA

Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France

EU/1/17/1199

Tablet

A16AX12

7.9.2017

5.9.2017

Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan

Efavirenz/emtricitabine/tenofovir disoproxil

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/17/1222

Film-coated tablet

J05AR06

7.9.2017

18.9.2017

Bavencio

avelumab

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/17/1214

Concentrate for solution for infusion

Pending

20.9.2017

18.9.2017

Entecavir Mylan

entecavir

Mylan S.A.S.

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/17/1227

Film-coated tablet

J05AF10

20.9.2017

18.9.2017

Lacosamide Accord

lacosamide

Accord Healthcare Limited

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

EU/1/17/1230

Film-coated tablet

N03AX18

20.9.2017

18.9.2017

Rydapt

Midostaurin

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/17/1218

Capsule, soft

L01XE39

20.9.2017

18.9.2017

Xermelo

telotristat

Ipsen Pharma

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

EU/1/17/1224

Film-coated tablet

Pending

20.9.2017

21.9.2017

Symtuza

darunavir/cobicistat/emtricitabine/tenofovir alafenamide

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/17/1225

Film-coated tablet

Pending

25.9.2017

21.9.2017

Tecentriq

atezolizumab

Roche Registration Limited

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

EU/1/17/1220

Concentrate for solution for infusion

Pending

25.9.2017

26.9.2017

Dupixent

dupilumab

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/17/1229

Solution for injection

Pending

28.9.2017

26.9.2017

Entecavir Accord

entecavir

Accord Healthcare Limited

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

EU/1/17/1211

Film-coated tablet

J05AF10

28.9.2017

26.9.2017

Lutathera

lutetium (177Lu) oxodotreotide

177

Advanced Accelerator Applications

20 rue Diesel, F-01630 Saint-Genis-Pouilly, France

EU/1/17/1226

Solution for infusion

V10XX04

28.9.2017

| — | Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Modification of a marketing authorisation

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 |
| --- | --- | --- | --- | --- |
| 5.9.2017 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 7.9.2017 |
| 5.9.2017 | Olazax | Glenmark Pharmaceuticals s.r.o.
  Hvězdova 1716/2b, 140 78 Praha 4, Česká republika. | EU/1/09/597 | 7.9.2017 |
| 5.9.2017 | Thorinane | Techdow Pharma Netherlands B.V.
  Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland | EU/1/16/1131 | 7.9.2017 |
| 7.9.2017 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/07/410 | 11.9.2017 |
| 7.9.2017 | Epoetin alfa Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411 | 11.9.2017 |
| 7.9.2017 | Fexeric | Keryx Biopharma UK Ltd.
  Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom | EU/1/15/1039 | 11.9.2017 |
| 7.9.2017 | Intanza | Sanofi Pasteur Europe
  2 Avenue Pont Pasteur, 69007 Lyon, France | EU/1/08/505 | 11.9.2017 |
| 7.9.2017 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 11.9.2017 |
| 11.9.2017 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 13.9.2017 |
| 11.9.2017 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 13.9.2017 |
| 11.9.2017 | Jinarc | Otsuka Pharmaceutical Europe Ltd.
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/15/1000 | 13.9.2017 |
| 11.9.2017 | Methylthioninium chloride Proveblue | Provepharm S.A.S.
  22 Rue Marc Donadille, 13013 Marseille, France | EU/1/11/682 | 14.9.2017 |
| 11.9.2017 | Neparvis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/16/1103 | 13.9.2017 |
| 11.9.2017 | Osseor | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/04/287 | 13.9.2017 |
| 11.9.2017 | Protelos | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/04/288 | 13.9.2017 |
| 11.9.2017 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/09/546 | 13.9.2017 |
| 11.9.2017 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 13.9.2017 |
| 11.9.2017 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 13.9.2017 |
| 11.9.2017 | Ventavis | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/03/255 | 13.9.2017 |
| 11.9.2017 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 13.9.2017 |
| 11.9.2017 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 13.9.2017 |
| 11.9.2017 | Zerit | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/96/009 | 13.9.2017 |
| 11.9.2017 | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/022 | 13.9.2017 |
| 14.9.2017 | Angiox | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/04/289 | 18.9.2017 |
| 14.9.2017 | Ebixa | H. Lundbeck A/S
  Ottiliavej 9, DK-2500 Valby, Danmark | EU/1/02/219 | 18.9.2017 |
| 14.9.2017 | Eurartesim | Alfasigma S.p.A.
  Viale Sarca, n. 223, 20126 Milano, Italia | EU/1/11/716 | 21.9.2017 |
| 14.9.2017 | Glidipion | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/12/756 | 18.9.2017 |
| 14.9.2017 | Ifirmasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/480 | 18.9.2017 |
| 14.9.2017 | Olanzapine Apotex | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/10/635 | 18.9.2017 |
| 14.9.2017 | Olazax Disperzi | Glenmark Pharmaceuticals s.r.o.
  City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika | EU/1/09/592 | 18.9.2017 |
| 14.9.2017 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 18.9.2017 |
| 14.9.2017 | Trevicta | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | 18.9.2017 |
| 14.9.2017 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 18.9.2017 |
| 14.9.2017 | Wakix | Bioprojet Pharma
  9 rue Rameau, F-75002 Paris, France | EU/1/15/1068 | 18.9.2017 |
| 18.9.2017 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412 | 20.9.2017 |
| 18.9.2017 | Betmiga | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/12/809 | 20.9.2017 |
| 18.9.2017 | Bexsero | GlaxoSmithKline Vaccines S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/12/812 | 20.9.2017 |
| 18.9.2017 | Blincyto | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | 20.9.2017 |
| 18.9.2017 | Gazyvaro | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | 20.9.2017 |
| 18.9.2017 | Ibandronic acid Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/798 | 20.9.2017 |
| 18.9.2017 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 20.9.2017 |
| 18.9.2017 | Lumark | IDB Holland B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | 20.9.2017 |
| 18.9.2017 | Lynparza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/959 | 20.9.2017 |
| 18.9.2017 | Lyxumia | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/811 | 20.9.2017 |
| 18.9.2017 | Mozobil | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/537 | 20.9.2017 |
| 18.9.2017 | NexoBrid | MediWound Germany GmbH
  Eisenstr. 5, D-65428 Ruesselsheim, Deutschland | EU/1/12/803 | 20.9.2017 |
| 18.9.2017 | Ninlaro | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/16/1094 | 20.9.2017 |
| 18.9.2017 | Nivestim | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/10/631 | 20.9.2017 |
| 18.9.2017 | NovoRapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/99/119 | 20.9.2017 |
| 18.9.2017 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 20.9.2017 |
| 18.9.2017 | Oslif Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/586 | 20.9.2017 |
| 18.9.2017 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 20.9.2017 |
| 18.9.2017 | Retacrit | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/07/431 | 20.9.2017 |
| 18.9.2017 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 20.9.2017 |
| 18.9.2017 | RoActemra | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492 | 20.9.2017 |
| 18.9.2017 | RotaTeq | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/348 | 20.9.2017 |
| 18.9.2017 | Samsca | Otsuka Pharmaceutical Europe Ltd.
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/09/539 | 21.9.2017 |
| 18.9.2017 | Signifor | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/753 | 20.9.2017 |
| 18.9.2017 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 20.9.2017 |
| 18.9.2017 | Zebinix | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 28.7.2017 |
| 18.9.2017 | Zebinix | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 20.9.2017 |
| 18.9.2017 | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/479 | 20.9.2017 |
| 21.9.2017 | Amyvid | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/12/805 | 25.9.2017 |
| 21.9.2017 | EndolucinBeta | ITG Isotope Technologies Garching GmbH
  Lichtenbergstr. 1, D-85748 Garching, Deutschland | EU/1/16/1105 | 25.9.2017 |
| 21.9.2017 | Iclusig | Incyte Biosciences UK Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 25.9.2017 |
| 21.9.2017 | Lartruvo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1143 | 25.9.2017 |
| 21.9.2017 | Lenvima | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/15/1002 | 25.9.2017 |
| 21.9.2017 | Plenadren | Shire Services BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/715 | 25.9.2017 |
| 21.9.2017 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 25.9.2017 |
| 21.9.2017 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 25.9.2017 |
| 21.9.2017 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/806 | 25.9.2017 |
| 21.9.2017 | Tresiba | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/807 | 25.9.2017 |
| 21.9.2017 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 25.9.2017 |
| 21.9.2017 | ZALTRAP | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | 25.9.2017 |
| 26.9.2017 | Hirobriz Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/594 | 28.9.2017 |
| 26.9.2017 | Onbrez Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/593 | 28.9.2017 |
| 26.9.2017 | Ristempa | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/996 | 28.9.2017 |
| 26.9.2017 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 28.9.2017 |
| 26.9.2017 | TachoSil | Takeda Austria GmbH
  St.-Peter-Strasse 25, A-4020 Linz, Österreich | EU/1/04/277 | 28.9.2017 |
| 26.9.2017 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 28.9.2017 |
| 26.9.2017 | Xoterna Breezhaler | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/863 | 28.9.2017 |
| 28.9.2017 | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/331 | 2.10.2017 |
| 28.9.2017 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 29.9.2017 |

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

5.9.2017

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

7.9.2017

5.9.2017

Olazax

Glenmark Pharmaceuticals s.r.o.

Hvězdova 1716/2b, 140 78 Praha 4, Česká republika.

EU/1/09/597

7.9.2017

5.9.2017

Thorinane

Techdow Pharma Netherlands B.V.

Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland

EU/1/16/1131

7.9.2017

7.9.2017

Binocrit

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/07/410

11.9.2017

7.9.2017

Epoetin alfa Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411

11.9.2017

7.9.2017

Fexeric

Keryx Biopharma UK Ltd.

Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom

EU/1/15/1039

11.9.2017

7.9.2017

Intanza

Sanofi Pasteur Europe

2 Avenue Pont Pasteur, 69007 Lyon, France

EU/1/08/505

11.9.2017

7.9.2017

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

11.9.2017

11.9.2017

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

13.9.2017

11.9.2017

Januvia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/383

13.9.2017

11.9.2017

Jinarc

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/15/1000

13.9.2017

11.9.2017

Methylthioninium chloride Proveblue

Provepharm S.A.S.

22 Rue Marc Donadille, 13013 Marseille, France

EU/1/11/682

14.9.2017

11.9.2017

Neparvis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/16/1103

13.9.2017

11.9.2017

Osseor

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/287

13.9.2017

11.9.2017

Protelos

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/04/288

13.9.2017

11.9.2017

Simponi

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

13.9.2017

11.9.2017

Tesavel

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/435

13.9.2017

11.9.2017

Tysabri

Biogen Idec Limited

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

EU/1/06/346

13.9.2017

11.9.2017

Ventavis

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/03/255

13.9.2017

11.9.2017

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

13.9.2017

11.9.2017

Xelevia

Merck Sharp & Dohme Limited

Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom

EU/1/07/382

13.9.2017

11.9.2017

Zerit

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/96/009

13.9.2017

11.9.2017

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

13.9.2017

14.9.2017

Angiox

The Medicines Company UK Ltd

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

EU/1/04/289

18.9.2017

14.9.2017

Ebixa

H. Lundbeck A/S

Ottiliavej 9, DK-2500 Valby, Danmark

EU/1/02/219

18.9.2017

14.9.2017

Eurartesim

Alfasigma S.p.A.

Viale Sarca, n. 223, 20126 Milano, Italia

EU/1/11/716

21.9.2017

14.9.2017

Glidipion

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/756

18.9.2017

14.9.2017

Ifirmasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

18.9.2017

14.9.2017

Olanzapine Apotex

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/10/635

18.9.2017

14.9.2017

Olazax Disperzi

Glenmark Pharmaceuticals s.r.o.

City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika

EU/1/09/592

18.9.2017

14.9.2017

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

18.9.2017

14.9.2017

Trevicta

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

18.9.2017

14.9.2017

Vimpat

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

18.9.2017

14.9.2017

Wakix

Bioprojet Pharma

9 rue Rameau, F-75002 Paris, France

EU/1/15/1068

18.9.2017

18.9.2017

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412

20.9.2017

18.9.2017

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

20.9.2017

18.9.2017

Bexsero

GlaxoSmithKline Vaccines S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/12/812

20.9.2017

18.9.2017

Blincyto

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

20.9.2017

18.9.2017

Gazyvaro

Roche Registration Limited

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

EU/1/14/937

20.9.2017

18.9.2017

Ibandronic acid Accord

Accord Healthcare Limited

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

EU/1/12/798

20.9.2017

18.9.2017

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

20.9.2017

18.9.2017

Lumark

IDB Holland B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

20.9.2017

18.9.2017

Lynparza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/959

20.9.2017

18.9.2017

Lyxumia

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/811

20.9.2017

18.9.2017

Mozobil

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

20.9.2017

18.9.2017

NexoBrid

MediWound Germany GmbH

Eisenstr. 5, D-65428 Ruesselsheim, Deutschland

EU/1/12/803

20.9.2017

18.9.2017

Ninlaro

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/16/1094

20.9.2017

18.9.2017

Nivestim

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/10/631

20.9.2017

18.9.2017

NovoRapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119

20.9.2017

18.9.2017

Opdivo

Bristol-Myers Squibb Pharma EEIG

Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom

EU/1/15/1014

20.9.2017

18.9.2017

Oslif Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/586

20.9.2017

18.9.2017

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

20.9.2017

18.9.2017

Retacrit

Hospira UK Limited

Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom

EU/1/07/431

20.9.2017

18.9.2017

Revlimid

Celgene Europe Limited

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

EU/1/07/391

20.9.2017

18.9.2017

RoActemra

Roche Registration Limited

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

EU/1/08/492

20.9.2017

18.9.2017

RotaTeq

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/348

20.9.2017

18.9.2017

Samsca

Otsuka Pharmaceutical Europe Ltd.

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/09/539

21.9.2017

18.9.2017

Signifor

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/753

20.9.2017

18.9.2017

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

20.9.2017

18.9.2017

Zebinix

Bial — Portela & Ca, SA

a

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal

EU/1/09/514

28.7.2017

18.9.2017

Zebinix

Bial — Portela & Ca, SA

a

À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal

EU/1/09/514

20.9.2017

18.9.2017

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

20.9.2017

21.9.2017

Amyvid

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/12/805

25.9.2017

21.9.2017

EndolucinBeta

ITG Isotope Technologies Garching GmbH

Lichtenbergstr. 1, D-85748 Garching, Deutschland

EU/1/16/1105

25.9.2017

21.9.2017

Iclusig

Incyte Biosciences UK Ltd

Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom

EU/1/13/839

25.9.2017

21.9.2017

Lartruvo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1143

25.9.2017

21.9.2017

Lenvima

Eisai Europe Limited

European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom

EU/1/15/1002

25.9.2017

21.9.2017

Plenadren

Shire Services BVBA

rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België

EU/1/11/715

25.9.2017

21.9.2017

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

25.9.2017

21.9.2017

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

25.9.2017

21.9.2017

Ryzodeg

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/806

25.9.2017

21.9.2017

Tresiba

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/807

25.9.2017

21.9.2017

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

25.9.2017

21.9.2017

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

25.9.2017

26.9.2017

Hirobriz Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/594

28.9.2017

26.9.2017

Onbrez Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/593

28.9.2017

26.9.2017

Ristempa

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/996

28.9.2017

26.9.2017

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

28.9.2017

26.9.2017

TachoSil

Takeda Austria GmbH

St.-Peter-Strasse 25, A-4020 Linz, Österreich

EU/1/04/277

28.9.2017

26.9.2017

Tracleer

Actelion Registration Ltd

Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom

EU/1/02/220

28.9.2017

26.9.2017

Xoterna Breezhaler

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/863

28.9.2017

28.9.2017

Neupro

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/05/331

2.10.2017

28.9.2017

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

29.9.2017

| — | Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorisation

| 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 |
| --- | --- | --- | --- | --- |
| 28.9.2017 | Ristempa | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/996 | 2.10.2017 |

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

28.9.2017

Ristempa

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/996

2.10.2017

| — | Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted |
| --- | --- |

—

Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Modification of a marketing authorisation

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 |
| --- | --- | --- | --- | --- |
| 7.9.2017 | SevoFlo | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/02/035 | 11.9.2017 |
| 14.9.2017 | Equilis Te | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/05/055 | 18.9.2017 |
| 14.9.2017 | LETIFEND | Laboratorios LETI, S.L.unipersonal
  C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España | EU/2/16/195 | 18.9.2017 |
| 14.9.2017 | Nobivac Myxo-RHD | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/132 | 18.9.2017 |
| 14.9.2017 | Rheumocam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/07/078 | 19.9.2017 |
| 21.9.2017 | Bovalto Ibraxion | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/99/017 | 25.9.2017 |
| 21.9.2017 | Pirsue | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/00/027 | 25.9.2017 |
| 21.9.2017 | Sevohale | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/16/196 | 25.9.2017 |
| 25.9.2017 | Equilis Prequenza Te | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/05/057 | 27.9.2017 |
| 25.9.2017 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 27.9.2017 |
| 28.9.2017 | ProZinc | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | 2.10.2017 |
| 28.9.2017 | Versican Plus L4 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/171 | 2.10.2017 |
| 28.9.2017 | Versican Plus Pi | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/168 | 2.10.2017 |
| 28.9.2017 | Versican Plus Pi/L4 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/172 | 2.10.2017 |

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

7.9.2017

SevoFlo

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/02/035

11.9.2017

14.9.2017

Equilis Te

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/05/055

18.9.2017

14.9.2017

LETIFEND

Laboratorios LETI, S.L.unipersonal

C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España

EU/2/16/195

18.9.2017

14.9.2017

Nobivac Myxo-RHD

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/11/132

18.9.2017

14.9.2017

Rheumocam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/07/078

19.9.2017

21.9.2017

Bovalto Ibraxion

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/99/017

25.9.2017

21.9.2017

Pirsue

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/00/027

25.9.2017

21.9.2017

Sevohale

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

25.9.2017

25.9.2017

Equilis Prequenza Te

Intervet International B.V.

Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland

EU/2/05/057

27.9.2017

25.9.2017

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

27.9.2017

28.9.2017

ProZinc

Boehringer Ingelheim Vetmedica GmbH

Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

EU/2/13/152

2.10.2017

28.9.2017

Versican Plus L4

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/171

2.10.2017

28.9.2017

Versican Plus Pi

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/168

2.10.2017

28.9.2017

Versican Plus Pi/L4

Zoetis Belgium S.A.

Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique

EU/2/14/172

2.10.2017

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 |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

(1)  OJ L 136, 30.4.2004, p. 1.

1

---