# C_2016277EN.01000101.xml

| 29.7.2016 | EN | Official Journal of the European Union | C 277/1 |
| --- | --- | --- | --- |

29.7.2016

EN

Official Journal of the European Union

C 277/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 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

(2016/C 277/01)

—   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

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.6.2016 | Odefsey | emtricitabine/rilpivirine/tenofovir alafenamide | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | Film-coated tablet | J05AR19 | 23.6.2016 |
| 24.6.2016 | Ongentys | opicapone | Bial — Portela & Ca, SA
  À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/15/1066 | Capsule, hard | Pending | 28.6.2016 |
| 24.6.2016 | Zavicefta | ceftazidime/avibactam | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/16/1109 | Powder for concentrate for solution for infusion | J01DD52 | 28.6.2016 |
| 29.6.2016 | Enzepi | pancreas powder | APTALIS PHARMA SAS
  5/6 Place de l’Iris — La Défense 5
  92400 Courbevoie France | EU/1/16/1113 | Capsule, hard, gastro-resistant | A09AA02 | 1.7.2016 |

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

21.6.2016

Odefsey

emtricitabine/rilpivirine/tenofovir alafenamide

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

Film-coated tablet

J05AR19

23.6.2016

24.6.2016

Ongentys

opicapone

Bial — Portela & Ca, SA

a

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

EU/1/15/1066

Capsule, hard

Pending

28.6.2016

24.6.2016

Zavicefta

ceftazidime/avibactam

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/16/1109

Powder for concentrate for solution for infusion

J01DD52

28.6.2016

29.6.2016

Enzepi

pancreas powder

APTALIS PHARMA SAS

5/6 Place de l’Iris — La Défense 5

92400 Courbevoie France

EU/1/16/1113

Capsule, hard, gastro-resistant

A09AA02

1.7.2016

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

Issuing of a marketing authorization

Rejected

| 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 |
| --- | --- | --- | --- | --- |
| 24.6.2016 | Dropcys | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | | 28.6.2016 |

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

24.6.2016

Dropcys

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

28.6.2016

—   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

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 |
| --- | --- | --- | --- | --- |
| 1.6.2016 | Cotellic | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/15/1048 | 3.6.2016 |
| 1.6.2016 | HyQvia | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/13/840 | 6.6.2016 |
| 1.6.2016 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 3.6.2016 |
| 1.6.2016 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 3.6.2016 |
| 2.6.2016 | Adrovance | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/364 | 6.6.2016 |
| 2.6.2016 | Altargo | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/07/390 | 6.6.2016 |
| 2.6.2016 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 6.6.2016 |
| 2.6.2016 | Capecitabine Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/762 | 6.6.2016 |
| 2.6.2016 | Clopidogrel BGR | Laboratoires BIOGARAN
  15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France | EU/1/09/558 | 6.6.2016 |
| 2.6.2016 | Clopidogrel Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/556 | 7.6.2016 |
| 2.6.2016 | Clopidogrel ratiopharm GmbH | Archie Samuel s.r.o.
  Slunná 16, CZ-61700 Brno, Česká republika | EU/1/09/541 | 6.6.2016 |
| 2.6.2016 | Imatinib Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/13/825 | 6.6.2016 |
| 2.6.2016 | Kineret | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/02/203 | 7.6.2016 |
| 2.6.2016 | Kiovig | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/05/329 | 6.6.2016 |
| 2.6.2016 | Lonquex | UAB ‘Sicor Biotech’
  Molėtų pl. 5, LT-08409 Vilnius, Lietuva | EU/1/13/856 | 6.6.2016 |
| 2.6.2016 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 6.6.2016 |
| 2.6.2016 | Tasigna | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/422 | 6.6.2016 |
| 2.6.2016 | Temozolomide Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/10/615 | 6.6.2016 |
| 2.6.2016 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 6.6.2016 |
| 9.6.2016 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 13.6.2016 |
| 9.6.2016 | Telmisartan Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/719 | 13.6.2016 |
| 9.6.2016 | VPRIV | Shire Pharmaceuticals Ireland Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646 | 13.6.2016 |
| 9.6.2016 | Zyllt | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/553 | 13.6.2016 |
| 13.6.2016 | Gazyvaro | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/14/937 | 15.6.2016 |
| 16.6.2016 | Advagraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/07/387 | 20.6.2016 |
| 16.6.2016 | Avonex | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/97/033 | 20.6.2016 |
| 16.6.2016 | Protopic | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/02/201 | 20.6.2016 |
| 16.6.2016 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 20.6.2016 |
| 16.6.2016 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 20.6.2016 |
| 21.6.2016 | Eurartesim | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
  Viale Shakespeare 47, 00144 Roma, Italia | EU/1/11/716 | 23.6.2016 |
| 21.6.2016 | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/376 | 23.6.2016 |
| 21.6.2016 | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/049 | 23.6.2016 |
| 21.6.2016 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 23.6.2016 |
| 21.6.2016 | Modigraf | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/09/523 | 23.6.2016 |
| 21.6.2016 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 23.6.2016 |
| 21.6.2016 | Zometa | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/176 | 23.6.2016 |
| 24.6.2016 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 28.6.2016 |
| 24.6.2016 | Advate | Baxter AG
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/03/271 | 28.6.2016 |
| 24.6.2016 | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/046 | 28.6.2016 |
| 24.6.2016 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 28.6.2016 |
| 24.6.2016 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 28.6.2016 |
| 24.6.2016 | Emtriva | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/03/261 | 28.6.2016 |
| 24.6.2016 | Grepid | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/09/535 | 28.6.2016 |
| 24.6.2016 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 28.6.2016 |
| 24.6.2016 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 28.6.2016 |
| 24.6.2016 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 28.6.2016 |
| 24.6.2016 | Rasilez | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/405 | 28.6.2016 |
| 24.6.2016 | Rasilez HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/491 | 28.6.2016 |
| 24.6.2016 | Relvar Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/13/886 | 28.6.2016 |
| 24.6.2016 | Revinty Ellipta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/14/929 | 28.6.2016 |
| 24.6.2016 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/09/546 | 28.6.2016 |
| 24.6.2016 | Tolura | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632 | 28.6.2016 |
| 24.6.2016 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 28.6.2016 |
| 24.6.2016 | Zoledronic acid Hospira | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/12/800 | 28.6.2016 |
| 29.6.2016 | Champix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/360 | 1.7.2016 |
| 29.6.2016 | Incivo | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/720 | 1.7.2016 |
| 29.6.2016 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 1.7.2016 |
| 29.6.2016 | Kyprolis | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1060 | 1.7.2016 |
| 29.6.2016 | Matever | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/11/711 | 1.7.2016 |
| 29.6.2016 | Memantine Mylan | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/13/827 | 8.7.2016 |
| 29.6.2016 | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/08/448 | 1.7.2016 |
| 29.6.2016 | PegIntron | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/131 | 1.7.2016 |
| 29.6.2016 | Revestive | NPS Pharma Holdings Limited
  5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland | EU/1/12/787 | 1.7.2016 |
| 29.6.2016 | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 1.7.2016 |
| 29.6.2016 | Vidaza | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/08/488 | 1.7.2016 |
| 29.6.2016 | ViraferonPeg | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/132 | 4.7.2016 |
| 29.6.2016 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 1.7.2016 |
| 29.6.2016 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 1.7.2016 |
| 30.6.2016 | Ceplene | Meda AB
  Box 906, SE-170 09 Solna, Sverige | EU/1/08/477 | 5.7.2016 |
| 30.6.2016 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 4.7.2016 |
| 30.6.2016 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 4.7.2016 |
| 30.6.2016 | Eylea | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/12/797 | 4.7.2016 |
| 30.6.2016 | Filgrastim Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/08/496 | 4.7.2016 |
| 30.6.2016 | Hycamtin | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/96/027 | 4.7.2016 |
| 30.6.2016 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 4.7.2016 |
| 30.6.2016 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | 4.7.2016 |
| 30.6.2016 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 4.7.2016 |
| 30.6.2016 | Toujeo | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/133 | 4.7.2016 |
| 30.6.2016 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 4.7.2016 |
| 30.6.2016 | Yentreve | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/280 | 4.7.2016 |
| 30.6.2016 | Zarzio | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/08/495 | 4.7.2016 |

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

1.6.2016

Cotellic

Roche Registration Limited

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

EU/1/15/1048

3.6.2016

1.6.2016

HyQvia

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/13/840

6.6.2016

1.6.2016

Revlimid

Celgene Europe Limited

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

EU/1/07/391

3.6.2016

1.6.2016

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

3.6.2016

2.6.2016

Adrovance

Merck Sharp & Dohme Limited

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

EU/1/06/364

6.6.2016

2.6.2016

Altargo

Glaxo Group Ltd

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

EU/1/07/390

6.6.2016

2.6.2016

Avastin

Roche Registration Limited

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

EU/1/04/300

6.6.2016

2.6.2016

Capecitabine Accord

Accord Healthcare Limited

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

EU/1/12/762

6.6.2016

2.6.2016

Clopidogrel BGR

Laboratoires BIOGARAN

15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France

EU/1/09/558

6.6.2016

2.6.2016

Clopidogrel Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/556

7.6.2016

2.6.2016

Clopidogrel ratiopharm GmbH

Archie Samuel s.r.o.

Slunná 16, CZ-61700 Brno, Česká republika

EU/1/09/541

6.6.2016

2.6.2016

Imatinib Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/13/825

6.6.2016

2.6.2016

Kineret

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/02/203

7.6.2016

2.6.2016

Kiovig

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/05/329

6.6.2016

2.6.2016

Lonquex

UAB ‘Sicor Biotech’

Molėtų pl. 5, LT-08409 Vilnius, Lietuva

EU/1/13/856

6.6.2016

2.6.2016

Neuraceq

Piramal Imaging Limited

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

EU/1/13/906

6.6.2016

2.6.2016

Tasigna

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/422

6.6.2016

2.6.2016

Temozolomide Accord

Accord Healthcare Limited

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

EU/1/10/615

6.6.2016

2.6.2016

Vimpat

UCB Pharma S.A.

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

EU/1/08/470

6.6.2016

9.6.2016

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

13.6.2016

9.6.2016

Telmisartan Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/719

13.6.2016

9.6.2016

VPRIV

Shire Pharmaceuticals Ireland Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646

13.6.2016

9.6.2016

Zyllt

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/553

13.6.2016

13.6.2016

Gazyvaro

Roche Registration Limited

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

EU/1/14/937

15.6.2016

16.6.2016

Advagraf

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/07/387

20.6.2016

16.6.2016

Avonex

Biogen Idec Limited

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

EU/1/97/033

20.6.2016

16.6.2016

Protopic

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/02/201

20.6.2016

16.6.2016

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

20.6.2016

16.6.2016

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

20.6.2016

21.6.2016

Eurartesim

Sigma-Tau Industrie Farmaceutiche Riunite S.p.A

Viale Shakespeare 47, 00144 Roma, Italia

EU/1/11/716

23.6.2016

21.6.2016

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/376

23.6.2016

21.6.2016

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/97/049

23.6.2016

21.6.2016

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

23.6.2016

21.6.2016

Modigraf

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/523

23.6.2016

21.6.2016

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267

23.6.2016

21.6.2016

Zometa

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/176

23.6.2016

24.6.2016

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

28.6.2016

24.6.2016

Advate

Baxter AG

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/03/271

28.6.2016

24.6.2016

Aprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/97/046

28.6.2016

24.6.2016

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

28.6.2016

24.6.2016

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

EU/1/14/939

28.6.2016

24.6.2016

Emtriva

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/03/261

28.6.2016

24.6.2016

Grepid

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/09/535

28.6.2016

24.6.2016

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

28.6.2016

24.6.2016

Imnovid

Celgene Europe Limited

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

EU/1/13/850

28.6.2016

24.6.2016

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

28.6.2016

24.6.2016

Rasilez

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/405

28.6.2016

24.6.2016

Rasilez HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/491

28.6.2016

24.6.2016

Relvar Ellipta

Glaxo Group Ltd

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

EU/1/13/886

28.6.2016

24.6.2016

Revinty Ellipta

Glaxo Group Ltd

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

EU/1/14/929

28.6.2016

24.6.2016

Simponi

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

28.6.2016

24.6.2016

Tolura

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632

28.6.2016

24.6.2016

Tysabri

Biogen Idec Limited

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

EU/1/06/346

28.6.2016

24.6.2016

Zoledronic acid Hospira

Hospira UK Limited

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

EU/1/12/800

28.6.2016

29.6.2016

Champix

Pfizer Limited

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

EU/1/06/360

1.7.2016

29.6.2016

Incivo

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/720

1.7.2016

29.6.2016

Kivexa

ViiV Healthcare UK Limited

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

EU/1/04/298

1.7.2016

29.6.2016

Kyprolis

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1060

1.7.2016

29.6.2016

Matever

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/11/711

1.7.2016

29.6.2016

Memantine Mylan

Generics [UK] Limited

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

EU/1/13/827

8.7.2016

29.6.2016

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/08/448

1.7.2016

29.6.2016

PegIntron

Merck Sharp & Dohme Limited

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

EU/1/00/131

1.7.2016

29.6.2016

Revestive

NPS Pharma Holdings Limited

5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

EU/1/12/787

1.7.2016

29.6.2016

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

1.7.2016

29.6.2016

Vidaza

Celgene Europe Limited

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

EU/1/08/488

1.7.2016

29.6.2016

ViraferonPeg

Merck Sharp & Dohme Limited

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

EU/1/00/132

4.7.2016

29.6.2016

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

1.7.2016

29.6.2016

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

1.7.2016

30.6.2016

Ceplene

Meda AB

Box 906, SE-170 09 Solna, Sverige

EU/1/08/477

5.7.2016

30.6.2016

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

4.7.2016

30.6.2016

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

4.7.2016

30.6.2016

Eylea

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/12/797

4.7.2016

30.6.2016

Filgrastim Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/08/496

4.7.2016

30.6.2016

Hycamtin

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/96/027

4.7.2016

30.6.2016

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

4.7.2016

30.6.2016

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

4.7.2016

30.6.2016

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

4.7.2016

30.6.2016

Toujeo

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/133

4.7.2016

30.6.2016

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

4.7.2016

30.6.2016

Yentreve

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/280

4.7.2016

30.6.2016

Zarzio

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/08/495

4.7.2016

—   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 |
| --- | --- | --- | --- | --- |
| 1.6.2016 | Clopidogrel/Acetylsalicylic acid Teva | Teva Pharma B.V.
  Swensweg 5, 2031GA Haarlem, Nederland | EU/1/14/942 | 3.6.2016 |
| 21.6.2016 | Capecitabine SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/13/831 | 23.6.2016 |
| 30.6.2016 | Krystexxa | Crealta Pharmaceuticals Ireland Limited
  Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland | EU/1/12/810 | 4.7.2016 |
| 30.6.2016 | Opgenra | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/08/489 | 4.7.2016 |

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

1.6.2016

Clopidogrel/Acetylsalicylic acid Teva

Teva Pharma B.V.

Swensweg 5, 2031GA Haarlem, Nederland

EU/1/14/942

3.6.2016

21.6.2016

Capecitabine SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/13/831

23.6.2016

30.6.2016

Krystexxa

Crealta Pharmaceuticals Ireland Limited

Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland

EU/1/12/810

4.7.2016

30.6.2016

Opgenra

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/08/489

4.7.2016

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 21.6.2016 | Sevocalm | sevoflurane | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/16/196 | Inhalation vapour, liquid | Pending | 24.6.2016 |

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

21.6.2016

Sevocalm

sevoflurane

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/16/196

Inhalation vapour, liquid

Pending

24.6.2016

—   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 |
| --- | --- | --- | --- | --- |
| 3.6.2016 | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/143 | 7.6.2016 |
| 21.6.2016 | Emdocam | Emdoka bvba
  J. Lijsenstraat 16, B-2321 Hoogstraten, België | EU/2/11/128 | 23.6.2016 |
| 21.6.2016 | Metacam | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/97/004 | 23.6.2016 |
| 22.6.2016 | Nobilis Influenza H5N2 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/06/061 | 24.6.2016 |
| 24.6.2016 | Loxicom | Norbrook Laboratories Ltd
  Station Works, Newry, Co. Down, BT35 6JP, United Kindgom | EU/2/08/090 | 29.6.2016 |

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

3.6.2016

Nobivac L4

Intervet International B.V.

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

EU/2/12/143

7.6.2016

21.6.2016

Emdocam

Emdoka bvba

J. Lijsenstraat 16, B-2321 Hoogstraten, België

EU/2/11/128

23.6.2016

21.6.2016

Metacam

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/97/004

23.6.2016

22.6.2016

Nobilis Influenza H5N2

Intervet International B.V.

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

EU/2/06/061

24.6.2016

24.6.2016

Loxicom

Norbrook Laboratories Ltd

Station Works, Newry, Co. Down, BT35 6JP, United Kindgom

EU/2/08/090

29.6.2016

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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