# C_2017028EN.01000101.xml

| 27.1.2017 | EN | Official Journal of the European Union | C 28/1 |
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27.1.2017

EN

Official Journal of the European Union

C 28/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2016 to 31 December 2016

(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 028/01)

- * *

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

—

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

Issuing of a marketing authorization

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 5.12.2016 | Venclyxto | venetoclax | AbbVie Ltd
  Vanwall Road, Maidenhead, SL6 4UB, United Kingdom | EU/1/16/1138 | Film-coated tablet | L01X | 7.12.2016 |
| 8.12.2016 | Emtricitabine/Tenofovir disoproxil Krka | emtricitabine/tenofovir disoproxil | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/16/1151 | Film-coated tablet | J05AR03 | 12.12.2016 |
| 8.12.2016 | SomaKit TOC | edotreotide | Advanced Accelerator Applications
  20 rue Diesel, F-1630 Saint-Genis-Pouilly, France | EU/1/16/1141 | Powder for solution for injection | V09IX09 | 12.12.2016 |
| 8.12.2016 | Tenofovir disoproxil Mylan | Tenofovir disoproxil | MYLAN S.A.S
  117 Allée des Parcs, 69800 Saint-Priest, France | EU/1/16/1129 | Film-coated tablet | J05AF07 | 12.12.2016 |
| 12.12.2016 | OCALIVA | obeticholic acid | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | Film-coated tablet | A05AA04 | 15.12.2016 |
| 12.12.2016 | Rekovelle | follitropin delta | Ferring Pharmaceuticals A/S
  Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark | EU/1/16/1150 | | G03GA10 | 14.12.2016 |
| 16.12.2016 | Emtricitabine/Tenofovir disoproxil Mylan | emtricitabine/tenofovir disoproxil | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1133 | Film-coated tablet | J05AR03 | 20.12.2016 |

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

5.12.2016

Venclyxto

venetoclax

AbbVie Ltd

Vanwall Road, Maidenhead, SL6 4UB, United Kingdom

EU/1/16/1138

Film-coated tablet

L01X

7.12.2016

8.12.2016

Emtricitabine/Tenofovir disoproxil Krka

emtricitabine/tenofovir disoproxil

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/16/1151

Film-coated tablet

J05AR03

12.12.2016

8.12.2016

SomaKit TOC

edotreotide

Advanced Accelerator Applications

20 rue Diesel, F-1630 Saint-Genis-Pouilly, France

EU/1/16/1141

Powder for solution for injection

V09IX09

12.12.2016

8.12.2016

Tenofovir disoproxil Mylan

Tenofovir disoproxil

MYLAN S.A.S

117 Allée des Parcs, 69800 Saint-Priest, France

EU/1/16/1129

Film-coated tablet

J05AF07

12.12.2016

12.12.2016

OCALIVA

obeticholic acid

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

Film-coated tablet

A05AA04

15.12.2016

12.12.2016

Rekovelle

follitropin delta

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark

EU/1/16/1150

G03GA10

14.12.2016

16.12.2016

Emtricitabine/Tenofovir disoproxil Mylan

emtricitabine/tenofovir disoproxil

Mylan S.A.S

117 allée des Parcs, F-69800 Saint Priest, France

EU/1/16/1133

Film-coated tablet

J05AR03

20.12.2016

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

—

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

Modification of a marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 2.12.2016 | Aclasta | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/308 | 6.12.2016 |
| 5.12.2016 | Pioglitazone Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/722 | 7.12.2016 |
| 5.12.2016 | Spedra | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/13/841 | 7.12.2016 |
| 5.12.2016 | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 7.12.2016 |
| 8.12.2016 | Actraphane | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/229 | 12.12.2016 |
| 8.12.2016 | Actrapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/230 | 12.12.2016 |
| 8.12.2016 | Adenuric | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/447 | 12.12.2016 |
| 8.12.2016 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 12.12.2016 |
| 8.12.2016 | CONTROLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/515 | 12.12.2016 |
| 8.12.2016 | Cystadane | Orphan Europe S.A.R.L.
  Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France | EU/1/06/379 | 12.12.2016 |
| 8.12.2016 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 12.12.2016 |
| 8.12.2016 | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 14.12.2016 |
| 8.12.2016 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 12.12.2016 |
| 8.12.2016 | Holoclar | Chiesi Farmaceutici S.P.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 12.12.2016 |
| 8.12.2016 | Icandra | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/484 | 12.12.2016 |
| 8.12.2016 | Lamivudine/Zidovudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/663 | 12.12.2016 |
| 8.12.2016 | Mimpara | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/04/292 | 5.12.2016 |
| 8.12.2016 | Otezla | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/14/981 | 12.12.2016 |
| 8.12.2016 | PANTOZOL Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/517 | 12.12.2016 |
| 8.12.2016 | SOMAC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/516 | 12.12.2016 |
| 8.12.2016 | Voriconazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/835 | 12.12.2016 |
| 8.12.2016 | Zebinix | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 12.12.2016 |
| 8.12.2016 | Zoledronic acid Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/12/759 | 12.12.2016 |
| 9.12.2016 | Ecansya | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/12/763 | 12.12.2016 |
| 12.12.2016 | Accofil | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/14/946 | 14.12.2016 |
| 12.12.2016 | Aldara | Meda AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | EU/1/98/080 | 14.12.2016 |
| 12.12.2016 | Aripiprazole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1045 | 14.12.2016 |
| 12.12.2016 | Colobreathe | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/747 | 14.12.2016 |
| 12.12.2016 | Cometriq | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/13/890 | 14.12.2016 |
| 12.12.2016 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 14.12.2016 |
| 12.12.2016 | Crixivan | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/96/024 | 14.12.2016 |
| 12.12.2016 | Docetaxel Kabi | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/12/770 | 15.12.2016 |
| 12.12.2016 | Ebymect | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/15/1051 | 14.12.2016 |
| 12.12.2016 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 14.12.2016 |
| 12.12.2016 | Eucreas | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/425 | 14.12.2016 |
| 12.12.2016 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa | EU/1/07/404 | 14.12.2016 |
| 12.12.2016 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 14.12.2016 |
| 12.12.2016 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 14.12.2016 |
| 12.12.2016 | Inflectra | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/13/854 | 14.12.2016 |
| 12.12.2016 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 14.12.2016 |
| 12.12.2016 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 14.12.2016 |
| 12.12.2016 | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 14.12.2016 |
| 12.12.2016 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1060 | 14.12.2016 |
| 12.12.2016 | Lynparza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/959 | 14.12.2016 |
| 12.12.2016 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 14.12.2016 |
| 12.12.2016 | Nimenrix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/767 | 14.12.2016 |
| 12.12.2016 | NovoMix | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142 | 14.12.2016 |
| 12.12.2016 | Optaflu | Seqirus GmbH
  Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland | EU/1/07/394 | 14.12.2016 |
| 12.12.2016 | Orbactiv | The Medicines Company UK Ltd
  115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom | EU/1/15/989 | 14.12.2016 |
| 12.12.2016 | Pregabalin Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1027 | 14.12.2016 |
| 12.12.2016 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 14.12.2016 |
| 12.12.2016 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 14.12.2016 |
| 12.12.2016 | TAGRISSO | AstraZeneca AB
  Gärtunavägen, SE-151 85 Södertälje, Sverige | EU/1/16/1086 | 14.12.2016 |
| 12.12.2016 | Trulicity | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/956 | 14.12.2016 |
| 12.12.2016 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 14.12.2016 |
| 12.12.2016 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 14.12.2016 |
| 12.12.2016 | Vipdomet | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/843 | 14.12.2016 |
| 12.12.2016 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 14.12.2016 |
| 12.12.2016 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 14.12.2016 |
| 12.12.2016 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 14.12.2016 |
| 12.12.2016 | Zomarist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/483 | 14.12.2016 |
| 13.12.2016 | GONAL-f | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/95/001 | 16.12.2016 |
| 16.12.2016 | Atripla | Bristol-Myers Squibb and Gilead Sciences Limited
  IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland | EU/1/07/430 | 21.12.2016 |
| 16.12.2016 | Caprelsa | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/11/749 | 20.12.2016 |
| 16.12.2016 | Kentera | Nicobrand Limited
  189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom | EU/1/03/270 | 20.12.2016 |
| 16.12.2016 | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 20.12.2016 |
| 16.12.2016 | Mixtard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/231 | 20.12.2016 |
| 16.12.2016 | Pemetrexed Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1034 | 20.12.2016 |
| 16.12.2016 | Pramipexole Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/08/490 | 20.12.2016 |
| 16.12.2016 | RotaTeq | Sanofi Pasteur MSD SAS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/348 | 20.12.2016 |
| 16.12.2016 | Sebivo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/388 | 20.12.2016 |
| 19.12.2016 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 21.12.2016 |
| 19.12.2016 | Pemetrexed Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1037 | 21.12.2016 |
| 19.12.2016 | Tractocile | Ferring Pharmaceuticals A/S
  Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark | EU/1/99/124 | 21.12.2016 |
| 19.12.2016 | Visudyne | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/00/140 | 21.12.2016 |
| 23.12.2016 | Duloxetine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/1010 | 5.1.2017 |
| 23.12.2016 | Fareston | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/96/004 | 4.1.2017 |
| 23.12.2016 | Invirase | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/026 | 4.1.2017 |
| 23.12.2016 | Mepact | Takeda France SAS
  Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France | EU/1/08/502 | 4.1.2017 |
| 23.12.2016 | Orkambi | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/15/1059 | 4.1.2017 |
| 23.12.2016 | Raplixa | Mallinckrodt Pharmaceuticals Ireland Limited
  College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland | EU/1/14/985 | 4.1.2017 |
| 23.12.2016 | Sirturo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/901 | 4.1.2017 |

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

2.12.2016

Aclasta

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/308

6.12.2016

5.12.2016

Pioglitazone Accord

Accord Healthcare Limited

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

EU/1/11/722

7.12.2016

5.12.2016

Spedra

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/13/841

7.12.2016

5.12.2016

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

7.12.2016

8.12.2016

Actraphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/229

12.12.2016

8.12.2016

Actrapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230

12.12.2016

8.12.2016

Adenuric

Menarini International Operations Luxembourg S.A.

1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

EU/1/08/447

12.12.2016

8.12.2016

Bosulif

Pfizer Limited

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

EU/1/13/818

12.12.2016

8.12.2016

CONTROLOC Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/515

12.12.2016

8.12.2016

Cystadane

Orphan Europe S.A.R.L.

Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France

EU/1/06/379

12.12.2016

8.12.2016

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

12.12.2016

8.12.2016

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

14.12.2016

8.12.2016

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

12.12.2016

8.12.2016

Holoclar

Chiesi Farmaceutici S.P.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

12.12.2016

8.12.2016

Icandra

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/484

12.12.2016

8.12.2016

Lamivudine/Zidovudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/663

12.12.2016

8.12.2016

Mimpara

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/04/292

5.12.2016

8.12.2016

Otezla

Celgene Europe Limited

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

EU/1/14/981

12.12.2016

8.12.2016

PANTOZOL Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/517

12.12.2016

8.12.2016

SOMAC Control

Takeda GmbH, (HRB 701016)

Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland

EU/1/09/516

12.12.2016

8.12.2016

Voriconazole Accord

Accord Healthcare Limited

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

EU/1/13/835

12.12.2016

8.12.2016

Zebinix

Bial — Portela & Ca, SA

a

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

EU/1/09/514

12.12.2016

8.12.2016

Zoledronic acid Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/12/759

12.12.2016

9.12.2016

Ecansya

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/12/763

12.12.2016

12.12.2016

Accofil

Accord Healthcare Limited

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

EU/1/14/946

14.12.2016

12.12.2016

Aldara

Meda AB

Pipers väg 2A, SE-170 73 Solna, Sverige

EU/1/98/080

14.12.2016

12.12.2016

Aripiprazole Accord

Accord Healthcare Limited

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

EU/1/15/1045

14.12.2016

12.12.2016

Colobreathe

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/747

14.12.2016

12.12.2016

Cometriq

Ipsen Pharma

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

EU/1/13/890

14.12.2016

12.12.2016

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

14.12.2016

12.12.2016

Crixivan

Merck Sharp & Dohme Limited

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

EU/1/96/024

14.12.2016

12.12.2016

Docetaxel Kabi

Fresenius Kabi Oncology Plc.

Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom

EU/1/12/770

15.12.2016

12.12.2016

Ebymect

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/15/1051

14.12.2016

12.12.2016

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

14.12.2016

12.12.2016

Eucreas

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/425

14.12.2016

12.12.2016

Flebogamma DIF

Instituto Grifols, S.A.

Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa

EU/1/07/404

14.12.2016

12.12.2016

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

14.12.2016

12.12.2016

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

14.12.2016

12.12.2016

Inflectra

Hospira UK Limited

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

EU/1/13/854

14.12.2016

12.12.2016

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

14.12.2016

12.12.2016

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

14.12.2016

12.12.2016

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

14.12.2016

12.12.2016

Kyprolis

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1060

14.12.2016

12.12.2016

Lynparza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/959

14.12.2016

12.12.2016

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

14.12.2016

12.12.2016

Nimenrix

Pfizer Limited

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

EU/1/12/767

14.12.2016

12.12.2016

NovoMix

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142

14.12.2016

12.12.2016

Optaflu

Seqirus GmbH

Emil-von-Behring-Strasse 76, 35041 Marburg, Deutschland

EU/1/07/394

14.12.2016

12.12.2016

Orbactiv

The Medicines Company UK Ltd

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

EU/1/15/989

14.12.2016

12.12.2016

Pregabalin Accord

Accord Healthcare Limited

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

EU/1/15/1027

14.12.2016

12.12.2016

Ristfor

Merck Sharp & Dohme Limited

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

EU/1/10/620

14.12.2016

12.12.2016

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

14.12.2016

12.12.2016

TAGRISSO

AstraZeneca AB

Gärtunavägen, SE-151 85 Södertälje, Sverige

EU/1/16/1086

14.12.2016

12.12.2016

Trulicity

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/956

14.12.2016

12.12.2016

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

14.12.2016

12.12.2016

Vimpat

UCB Pharma S.A.

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

EU/1/08/470

14.12.2016

12.12.2016

Vipdomet

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/843

14.12.2016

12.12.2016

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

14.12.2016

12.12.2016

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

14.12.2016

12.12.2016

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

14.12.2016

12.12.2016

Zomarist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/483

14.12.2016

13.12.2016

GONAL-f

Merck Serono Europe Limited

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

EU/1/95/001

16.12.2016

16.12.2016

Atripla

Bristol-Myers Squibb and Gilead Sciences Limited

IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

EU/1/07/430

21.12.2016

16.12.2016

Caprelsa

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/11/749

20.12.2016

16.12.2016

Kentera

Nicobrand Limited

189 Castleroe Road, Coleraine, Northern Ireland BT51 3 RP, United Kindom

EU/1/03/270

20.12.2016

16.12.2016

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278

20.12.2016

16.12.2016

Mixtard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/231

20.12.2016

16.12.2016

Pemetrexed Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1034

20.12.2016

16.12.2016

Pramipexole Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/08/490

20.12.2016

16.12.2016

RotaTeq

Sanofi Pasteur MSD SAS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/348

20.12.2016

16.12.2016

Sebivo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/388

20.12.2016

19.12.2016

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

21.12.2016

19.12.2016

Pemetrexed Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1037

21.12.2016

19.12.2016

Tractocile

Ferring Pharmaceuticals A/S

Kay Fiskers Plads 11, DK-2300 Copenhagen S, Danmark

EU/1/99/124

21.12.2016

19.12.2016

Visudyne

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/00/140

21.12.2016

23.12.2016

Duloxetine Mylan

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/1010

5.1.2017

23.12.2016

Fareston

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/96/004

4.1.2017

23.12.2016

Invirase

Roche Registration Limited

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

EU/1/96/026

4.1.2017

23.12.2016

Mepact

Takeda France SAS

Immeuble Pacific, 11-13 cours Valmy, 92800 Puteaux, France

EU/1/08/502

4.1.2017

23.12.2016

Orkambi

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/15/1059

4.1.2017

23.12.2016

Raplixa

Mallinckrodt Pharmaceuticals Ireland Limited

College Business & Technology Park Cruiserath, Blanchardstown, Dublin 15, Ireland

EU/1/14/985

4.1.2017

23.12.2016

Sirturo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/901

4.1.2017

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

Withdrawal of a marketing authorization

| 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 |
| --- | --- | --- | --- | --- |
| 16.12.2016 | Budesonide/Formoterol Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/948 | 20.12.2016 |
| 16.12.2016 | Budesonide/Formoterol Teva Pharma B.V. | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/950 | 20.12.2016 |

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

16.12.2016

Budesonide/Formoterol Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/948

20.12.2016

16.12.2016

Budesonide/Formoterol Teva Pharma B.V.

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/950

20.12.2016

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

Issuing of a marketing authorization

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.12.2016 | Cepedex | dexmedetomidine | CP Pharma Handelsgesellschaft mbH
  Ostlandring 13, D-31303 Burgdorf, Deutschland | EU/2/16/200 | Solution for injection | QN05CM18 | 15.12.2016 |
| 13.12.2016 | Halagon | halofuginone | Emdoka bvba
  J. Lijsenstraat 16, B-2321 Hoogstraten, België | EU/2/16/201 | Oral solution | QP51AX08 | 15.12.2016 |

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

13.12.2016

Cepedex

dexmedetomidine

CP Pharma Handelsgesellschaft mbH

Ostlandring 13, D-31303 Burgdorf, Deutschland

EU/2/16/200

Solution for injection

QN05CM18

15.12.2016

13.12.2016

Halagon

halofuginone

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, België

EU/2/16/201

Oral solution

QP51AX08

15.12.2016

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

Modification of a marketing authorization

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 |
| --- | --- | --- | --- | --- |
| 13.12.2016 | Parvoduk | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/14/162 | 15.12.2016 |
| 13.12.2016 | Zulvac 1 + 8 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/139 | 15.12.2016 |
| 14.12.2016 | Activyl Tick Plus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/11/137 | 16.12.2016 |
| 14.12.2016 | Porcilis PCV M Hyo | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/175 | 16.12.2016 |
| 14.12.2016 | Versican Plus DHPPi | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/169 | 16.12.2016 |
| 14.12.2016 | Versican Plus DHPPi/L4 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/164 | 16.12.2016 |
| 14.12.2016 | Versican Plus DHPPi/L4R | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/163 | 16.12.2016 |

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

13.12.2016

Parvoduk

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/14/162

15.12.2016

13.12.2016

Zulvac 1 + 8 Bovis

Zoetis Belgium S.A.

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

EU/2/12/139

15.12.2016

14.12.2016

Activyl Tick Plus

Intervet International B.V.

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

EU/2/11/137

16.12.2016

14.12.2016

Porcilis PCV M Hyo

Intervet International B.V.

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

EU/2/14/175

16.12.2016

14.12.2016

Versican Plus DHPPi

Zoetis Belgium S.A.

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

EU/2/14/169

16.12.2016

14.12.2016

Versican Plus DHPPi/L4

Zoetis Belgium S.A.

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

EU/2/14/164

16.12.2016

14.12.2016

Versican Plus DHPPi/L4R

Zoetis Belgium S.A.

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

EU/2/14/163

16.12.2016

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

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