# C_2014386EN.01000301.xml

| 31.10.2014 | EN | Official Journal of the European Union | C 386/3 |
| --- | --- | --- | --- |

31.10.2014

EN

Official Journal of the European Union

C 386/3

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2014 to 30 September 2014

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

1

2014/C 386/02

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.9.2014 | Clopidogrel/Acetylsalicylic acid Teva | clopidogrel/acetylsalicylic acid | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/942 | Film-coated tablet | B01AC30 | 3.9.2014 |
| 1.9.2014 | Triumeq | dolutegravir/abacavir/lamivudine | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/14/940 | Film-coated tablet | J05AR13 | 3.9.2014 |
| 9.9.2014 | ABASRIA | Insulin glargine | Eli Lilly Regional Operations GmbH.
  Kölblgasse 8-10, 1030 Wien, Österreich | EU/1/14/944 | Solution for injection | A10AE04 | 11.9.2014 |
| 18.9.2014 | Accofil | Filgrastim | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/14/946 | Solution for injection or infusion | L03AA02 | 22.9.2014 |
| 18.9.2014 | Xultophy | insulin degludec/liraglutide | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | Solution for injection in pre-filled pen | Pending | 22.9.2014 |
| 18.9.2014 | Zydelig | idelalisib | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/938 | Film-coated tablet | L01XX47 | 19.9.2014 |
| 22.9.2014 | Busulfan Fresenius Kabi | busulfan | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/14/951 | Concentrate for solution for infusion | L01AB01 | 24.9.2014 |

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

1.9.2014

Clopidogrel/Acetylsalicylic acid Teva

clopidogrel/acetylsalicylic acid

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/942

Film-coated tablet

B01AC30

3.9.2014

1.9.2014

Triumeq

dolutegravir/abacavir/lamivudine

ViiV Healthcare UK Limited

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

EU/1/14/940

Film-coated tablet

J05AR13

3.9.2014

9.9.2014

ABASRIA

Insulin glargine

Eli Lilly Regional Operations GmbH.

Kölblgasse 8-10, 1030 Wien, Österreich

EU/1/14/944

Solution for injection

A10AE04

11.9.2014

18.9.2014

Accofil

Filgrastim

Accord Healthcare Limited

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

EU/1/14/946

Solution for injection or infusion

L03AA02

22.9.2014

18.9.2014

Xultophy

insulin degludec/liraglutide

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

Solution for injection in pre-filled pen

Pending

22.9.2014

18.9.2014

Zydelig

idelalisib

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/938

Film-coated tablet

L01XX47

19.9.2014

22.9.2014

Busulfan Fresenius Kabi

busulfan

Fresenius Kabi Oncology Plc.

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

EU/1/14/951

Concentrate for solution for infusion

L01AB01

24.9.2014

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2014 | Daliresp | Takeda GmbH
  Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | EU/1/11/668 | 3.9.2014 |
| 1.9.2014 | Daxas | Takeda GmbH
  Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | EU/1/10/636 | 3.9.2014 |
| 1.9.2014 | Desloratadine ratiopharm | Ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/746 | 4.9.2014 |
| 1.9.2014 | DuoCover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 3.9.2014 |
| 1.9.2014 | EDURANT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/736 | 3.9.2014 |
| 1.9.2014 | Humira | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/03/256 | 3.9.2014 |
| 1.9.2014 | Imatinib Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/13/845 | 3.9.2014 |
| 1.9.2014 | Libertek | Takeda GmbH
  Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland | EU/1/11/666 | 3.9.2014 |
| 1.9.2014 | Macugen | PharmaSwiss Česká republika s.r.o.
  Jankovcova 1569/2c 17000 Praha 7 Czech Republic | EU/1/05/325 | 3.9.2014 |
| 1.9.2014 | PHEBURANE | Lucane Pharma
  172 rue de Charonne, 75011 Paris, France | EU/1/13/822 | 3.9.2014 |
| 1.9.2014 | Pixuvri | CTI Life Sciences Ltd
  Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 3.9.2014 |
| 1.9.2014 | RoActemra | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492 | 3.9.2014 |
| 1.9.2014 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 3.9.2014 |
| 1.9.2014 | Zoely | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/690 | 4.9.2014 |
| 4.9.2014 | Actelsar HCT | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/817 | 8.9.2014 |
| 4.9.2014 | Aprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/046 | 8.9.2014 |
| 4.9.2014 | CoAprovel | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/086 | 8.9.2014 |
| 4.9.2014 | Copalia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/372 | 8.9.2014 |
| 4.9.2014 | Copalia HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/575 | 8.9.2014 |
| 4.9.2014 | Dafiro | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/371 | 8.9.2014 |
| 4.9.2014 | Dafiro HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/574 | 8.9.2014 |
| 4.9.2014 | Exforge | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/370 | 8.9.2014 |
| 4.9.2014 | Exforge HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/569 | 8.9.2014 |
| 4.9.2014 | Exjade | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/356 | 8.9.2014 |
| 4.9.2014 | Extavia | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/454 | 8.9.2014 |
| 4.9.2014 | Ifirmacombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/673 | 8.9.2014 |
| 4.9.2014 | Ifirmasta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/08/480 | 8.9.2014 |
| 4.9.2014 | Imprida | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/373 | 8.9.2014 |
| 4.9.2014 | Irbesartan HCT Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/377 | 8.9.2014 |
| 4.9.2014 | Irbesartan/Hydrochlorothiazide Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/583 | 8.9.2014 |
| 4.9.2014 | Irbesartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/576 | 8.9.2014 |
| 4.9.2014 | Irbesartan Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/06/376 | 8.9.2014 |
| 4.9.2014 | Karvea | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/97/049 | 8.9.2014 |
| 4.9.2014 | Karvezide | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/085 | 8.9.2014 |
| 4.9.2014 | Kinzalkomb | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/214 | 8.9.2014 |
| 4.9.2014 | Kinzalmono | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/98/091 | 8.9.2014 |
| 4.9.2014 | Lucentis | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/06/374 | 8.9.2014 |
| 4.9.2014 | Micardis | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/98/090 | 8.9.2014 |
| 4.9.2014 | MicardisPlus | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/02/213 | 8.9.2014 |
| 4.9.2014 | Pritor | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/98/089 | 8.9.2014 |
| 4.9.2014 | PritorPlus | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/02/215 | 8.9.2014 |
| 4.9.2014 | Rasilez | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/07/405 | 8.9.2014 |
| 4.9.2014 | Rasilez HCT | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/08/491 | 8.9.2014 |
| 4.9.2014 | Sabervel | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/12/765 | 8.9.2014 |
| 4.9.2014 | Sildenafil Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/09/595 | 8.9.2014 |
| 4.9.2014 | Simulect | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/084 | 8.9.2014 |
| 4.9.2014 | Telmisartan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/10/639 | 8.9.2014 |
| 4.9.2014 | Telmisartan Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/610 | 8.9.2014 |
| 4.9.2014 | Telmisartan Teva Pharma | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/11/719 | 8.9.2014 |
| 4.9.2014 | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 8.9.2014 |
| 4.9.2014 | Tolura | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/10/632 | 8.9.2014 |
| 4.9.2014 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 8.9.2014 |
| 9.9.2014 | Edarbi | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/734 | 11.9.2014 |
| 9.9.2014 | Ipreziv | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/11/735 | 11.9.2014 |
| 9.9.2014 | Lamivudine Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/566 | 12.9.2014 |
| 9.9.2014 | Rasilamlo | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/11/686 | 11.9.2014 |
| 9.9.2014 | Sildenafil ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/603 | 11.9.2014 |
| 9.9.2014 | Sildenafil Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/584 | 12.9.2014 |
| 9.9.2014 | Stribild | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/830 | 10.9.2014 |
| 11.9.2014 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/96/011 | 15.9.2014 |
| 11.9.2014 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 15.9.2014 |
| 11.9.2014 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 16.9.2014 |
| 11.9.2014 | Kolbam | ASK Pharmaceuticals GmbH
  Heimeranstraße 35, D-80339 München, Deutschland | EU/1/13/895 | 15.9.2014 |
| 11.9.2014 | Lamivudine Teva Pharma B.V. | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/596 | 15.9.2014 |
| 11.9.2014 | Relistor | TMC Pharma Services Ltd
  Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom | EU/1/08/463 | 15.9.2014 |
| 16.9.2014 | Aranesp | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/01/185 | 19.9.2014 |
| 16.9.2014 | Ovaleap | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/13/871 | 18.9.2014 |
| 16.9.2014 | Zutectra | Biotest Pharma GmbH
  Landsteinerstrasse 5, D-63303 Dreieich, Deutschland | EU/1/09/600 | 18.9.2014 |
| 18.9.2014 | Clopidogrel Apotex | Apotex Europe B.V.
  Darwinweg 20, NL-2333 CR Leiden, Nederland | EU/1/09/568 | 22.9.2014 |
| 18.9.2014 | Clopidogrel Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/08/465 | 22.9.2014 |
| 18.9.2014 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 22.9.2014 |
| 18.9.2014 | Hirobriz Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/594 | 22.9.2014 |
| 18.9.2014 | Iclusig | ARIAD Pharma Ltd
  Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom | EU/1/13/839 | 22.9.2014 |
| 18.9.2014 | Ilaris | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/564 | 22.9.2014 |
| 18.9.2014 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 22.9.2014 |
| 18.9.2014 | Noxafil | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/320 | 22.9.2014 |
| 18.9.2014 | Onbrez Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/593 | 22.9.2014 |
| 18.9.2014 | Oslif Breezhaler | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/09/586 | 22.9.2014 |
| 18.9.2014 | Prevenar 13 | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/590 | 22.9.2014 |
| 18.9.2014 | Prialt | Eisai Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom | EU/1/04/302 | 22.9.2014 |
| 18.9.2014 | Rienso | Takeda Pharma A/S
  PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark | EU/1/12/774 | 22.9.2014 |
| 18.9.2014 | Silodyx | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/607 | 22.9.2014 |
| 18.9.2014 | Trajenta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/11/707 | 22.9.2014 |
| 18.9.2014 | Urorec | Recordati Ireland Ltd
  Raheens East, Ringaskiddy Co. Cork, Ireland | EU/1/09/608 | 22.9.2014 |
| 18.9.2014 | Vantavo | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/09/572 | 22.9.2014 |
| 22.9.2014 | Mozobil | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/09/537 | 24.9.2014 |
| 22.9.2014 | Multaq | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/09/591 | 24.9.2014 |
| 30.9.2014 | Cinryze | ViroPharma SPRL-BVBA
  rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België | EU/1/11/688 | 2.10.2014 |
| 30.9.2014 | Humalog | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/96/007 | 2.10.2014 |
| 30.9.2014 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 6.10.2014 |
| 30.9.2014 | Inflectra | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/13/854 | 2.10.2014 |
| 30.9.2014 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 2.10.2014 |
| 30.9.2014 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 2.10.2014 |

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

1.9.2014

Daliresp

Takeda GmbH

Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

EU/1/11/668

3.9.2014

1.9.2014

Daxas

Takeda GmbH

Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

EU/1/10/636

3.9.2014

1.9.2014

Desloratadine ratiopharm

Ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/11/746

4.9.2014

1.9.2014

DuoCover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

3.9.2014

1.9.2014

EDURANT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/736

3.9.2014

1.9.2014

Humira

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

3.9.2014

1.9.2014

Imatinib Accord

Accord Healthcare Limited

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

EU/1/13/845

3.9.2014

1.9.2014

Libertek

Takeda GmbH

Byk-Gulden-Straße 2, D-78467 Konstanz, Deutschland

EU/1/11/666

3.9.2014

1.9.2014

Macugen

PharmaSwiss Česká republika s.r.o.

Jankovcova 1569/2c 17000 Praha 7 Czech Republic

EU/1/05/325

3.9.2014

1.9.2014

PHEBURANE

Lucane Pharma

172 rue de Charonne, 75011 Paris, France

EU/1/13/822

3.9.2014

1.9.2014

Pixuvri

CTI Life Sciences Ltd

Highlands House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom

EU/1/12/764

3.9.2014

1.9.2014

RoActemra

Roche Registration Limited

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

EU/1/08/492

3.9.2014

1.9.2014

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

3.9.2014

1.9.2014

Zoely

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/690

4.9.2014

4.9.2014

Actelsar HCT

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/817

8.9.2014

4.9.2014

Aprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/97/046

8.9.2014

4.9.2014

CoAprovel

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/086

8.9.2014

4.9.2014

Copalia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/372

8.9.2014

4.9.2014

Copalia HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/575

8.9.2014

4.9.2014

Dafiro

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/371

8.9.2014

4.9.2014

Dafiro HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/574

8.9.2014

4.9.2014

Exforge

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/370

8.9.2014

4.9.2014

Exforge HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/569

8.9.2014

4.9.2014

Exjade

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/356

8.9.2014

4.9.2014

Extavia

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/454

8.9.2014

4.9.2014

Ifirmacombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/673

8.9.2014

4.9.2014

Ifirmasta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/08/480

8.9.2014

4.9.2014

Imprida

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/373

8.9.2014

4.9.2014

Irbesartan HCT Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/377

8.9.2014

4.9.2014

Irbesartan/Hydrochlorothiazide Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/583

8.9.2014

4.9.2014

Irbesartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/576

8.9.2014

4.9.2014

Irbesartan Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/06/376

8.9.2014

4.9.2014

Karvea

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/97/049

8.9.2014

4.9.2014

Karvezide

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/98/085

8.9.2014

4.9.2014

Kinzalkomb

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/214

8.9.2014

4.9.2014

Kinzalmono

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/091

8.9.2014

4.9.2014

Lucentis

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/06/374

8.9.2014

4.9.2014

Micardis

Boehringer Ingelheim International GmbH

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

EU/1/98/090

8.9.2014

4.9.2014

MicardisPlus

Boehringer Ingelheim International GmbH

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

EU/1/02/213

8.9.2014

4.9.2014

Pritor

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/98/089

8.9.2014

4.9.2014

PritorPlus

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/02/215

8.9.2014

4.9.2014

Rasilez

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/07/405

8.9.2014

4.9.2014

Rasilez HCT

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/08/491

8.9.2014

4.9.2014

Sabervel

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/12/765

8.9.2014

4.9.2014

Sildenafil Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/09/595

8.9.2014

4.9.2014

Simulect

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/98/084

8.9.2014

4.9.2014

Telmisartan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/639

8.9.2014

4.9.2014

Telmisartan Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/610

8.9.2014

4.9.2014

Telmisartan Teva Pharma

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/11/719

8.9.2014

4.9.2014

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

8.9.2014

4.9.2014

Tolura

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/10/632

8.9.2014

4.9.2014

Twynsta

Boehringer Ingelheim International GmbH

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

EU/1/10/648

8.9.2014

9.9.2014

Edarbi

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/734

11.9.2014

9.9.2014

Ipreziv

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/11/735

11.9.2014

9.9.2014

Lamivudine Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/566

12.9.2014

9.9.2014

Rasilamlo

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/11/686

11.9.2014

9.9.2014

Sildenafil ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/603

11.9.2014

9.9.2014

Sildenafil Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/584

12.9.2014

9.9.2014

Stribild

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

10.9.2014

11.9.2014

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011

15.9.2014

11.9.2014

Eporatio

ratiopharm GmbH

Graf-Arco-Straße 3, D-89079 Ulm, Deutschland

EU/1/09/573

15.9.2014

11.9.2014

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

16.9.2014

11.9.2014

Kolbam

ASK Pharmaceuticals GmbH

Heimeranstraße 35, D-80339 München, Deutschland

EU/1/13/895

15.9.2014

11.9.2014

Lamivudine Teva Pharma B.V.

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/596

15.9.2014

11.9.2014

Relistor

TMC Pharma Services Ltd

Lodge Farm Barn, Elvetham Park Estate, Fleet Road, Hartley Wintney, Hampshire RG27 8AS, United Kingdom

EU/1/08/463

15.9.2014

16.9.2014

Aranesp

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/01/185

19.9.2014

16.9.2014

Ovaleap

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/13/871

18.9.2014

16.9.2014

Zutectra

Biotest Pharma GmbH

Landsteinerstrasse 5, D-63303 Dreieich, Deutschland

EU/1/09/600

18.9.2014

18.9.2014

Clopidogrel Apotex

Apotex Europe B.V.

Darwinweg 20, NL-2333 CR Leiden, Nederland

EU/1/09/568

22.9.2014

18.9.2014

Clopidogrel Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/08/465

22.9.2014

18.9.2014

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

22.9.2014

18.9.2014

Hirobriz Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/594

22.9.2014

18.9.2014

Iclusig

ARIAD Pharma Ltd

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

EU/1/13/839

22.9.2014

18.9.2014

Ilaris

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/564

22.9.2014

18.9.2014

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

22.9.2014

18.9.2014

Noxafil

Merck Sharp & Dohme Limited

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

EU/1/05/320

22.9.2014

18.9.2014

Onbrez Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/593

22.9.2014

18.9.2014

Oslif Breezhaler

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/09/586

22.9.2014

18.9.2014

Prevenar 13

Pfizer Limited

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

EU/1/09/590

22.9.2014

18.9.2014

Prialt

Eisai Limited

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

EU/1/04/302

22.9.2014

18.9.2014

Rienso

Takeda Pharma A/S

PO Box 88, Langebjerg 1, DK-4000 Roskilde, Danmark

EU/1/12/774

22.9.2014

18.9.2014

Silodyx

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/607

22.9.2014

18.9.2014

Trajenta

Boehringer Ingelheim International GmbH

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

EU/1/11/707

22.9.2014

18.9.2014

Urorec

Recordati Ireland Ltd

Raheens East, Ringaskiddy Co. Cork, Ireland

EU/1/09/608

22.9.2014

18.9.2014

Vantavo

Merck Sharp & Dohme Limited

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

EU/1/09/572

22.9.2014

22.9.2014

Mozobil

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/09/537

24.9.2014

22.9.2014

Multaq

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/09/591

24.9.2014

30.9.2014

Cinryze

ViroPharma SPRL-BVBA

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

EU/1/11/688

2.10.2014

30.9.2014

Humalog

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/96/007

2.10.2014

30.9.2014

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

6.10.2014

30.9.2014

Inflectra

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/13/854

2.10.2014

30.9.2014

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

2.10.2014

30.9.2014

Revlimid

Celgene Europe Limited

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

EU/1/07/391

2.10.2014

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2014 | Clopidogrel Qualimed | Qualimed
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/09/557 | 3.9.2014 |
| 16.9.2014 | Pioglitazone Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/723 | 18.9.2014 |

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

1.9.2014

Clopidogrel Qualimed

Qualimed

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

EU/1/09/557

3.9.2014

16.9.2014

Pioglitazone Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/723

18.9.2014

—   Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): Accepted

Issuing of a marketing authorization

2

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.9.2014 | Nobilis IB Primo QX | Live avian infectious bronchitis virus, strain D388 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/174 | Lyophilisate and solvent for oculonasal suspension
  Lyophilisate for suspension for spray | QI01AD07 | 8.9.2014 |

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

4.9.2014

Nobilis IB Primo QX

Live avian infectious bronchitis virus, strain D388

Intervet International B.V.

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

EU/2/14/174

Lyophilisate and solvent for oculonasal suspension

Lyophilisate for suspension for spray

QI01AD07

8.9.2014

—   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 |
| --- | --- | --- | --- | --- |
| 1.9.2014 | Inflacam | Chanelle Pharmaceuticals Manufacturing Limited
  Loughrea, Co. Galway, Ireland | EU/2/11/134 | 3.9.2014 |
| 1.9.2014 | Suvaxyn Aujeszky 783 + O/W | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/98/009 | 3.9.2014 |
| 9.9.2014 | Aivlosin | ECO Animal Health Ltd
  78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom | EU/2/04/044 | 11.9.2014 |
| 9.9.2014 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 11.9.2014 |
| 9.9.2014 | Pirsue | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/00/027 | 11.9.2014 |
| 9.9.2014 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 11.9.2014 |
| 9.9.2014 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 11.9.2014 |
| 16.9.2014 | Zulvac 1+8 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/120 | 18.9.2014 |
| 30.9.2014 | Ingelvac CircoFLEX | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/07/079 | 2.10.2014 |
| 30.9.2014 | Meloxoral | Le Vet B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/10/111 | 2.10.2014 |

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

1.9.2014

Inflacam

Chanelle Pharmaceuticals Manufacturing Limited

Loughrea, Co. Galway, Ireland

EU/2/11/134

3.9.2014

1.9.2014

Suvaxyn Aujeszky 783 + O/W

Zoetis Belgium S.A.

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

EU/2/98/009

3.9.2014

9.9.2014

Aivlosin

ECO Animal Health Ltd

78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom

EU/2/04/044

11.9.2014

9.9.2014

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

11.9.2014

9.9.2014

Pirsue

Zoetis Belgium S.A.

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

EU/2/00/027

11.9.2014

9.9.2014

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

11.9.2014

9.9.2014

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

11.9.2014

16.9.2014

Zulvac 1+8 Ovis

Zoetis Belgium S.A.

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

EU/2/11/120

18.9.2014

30.9.2014

Ingelvac CircoFLEX

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/07/079

2.10.2014

30.9.2014

Meloxoral

Le Vet B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/10/111

2.10.2014

Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

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(1)  OJ L 136, 30.4.04, p. 1.

1

(2)  OJ L 136, 30.4.04, p. 1.

2

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