# C_2014467EN.01000101.xml

| 30.12.2014 | EN | Official Journal of the European Union | C 467/1 |
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30.12.2014

EN

Official Journal of the European Union

C 467/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2014 to 30 November 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 467/01)

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

Issuing of a marketing authorisation

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 17.11.2014 | Harvoni | ledipasvir/sofosbuvir | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | Film-coated tablet | Pending | 18.11.2014 |
| 19.11.2014 | Brimica Genuair | aclidinium bromide/formoterol fumarate dihydrate | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/963 | Inhalation powder | R03AL05 | 21.11.2014 |
| 19.11.2014 | Budesonide/Formoterol Teva | budesonide/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/948 | Inhalation powder | R03AK07 | 24.11.2014 |
| 19.11.2014 | Budesonide/Formoterol Teva Pharma B.V. | budesonide/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/950 | Inhalation powder | R03AK07 | 21.11.2014 |
| 19.11.2014 | Duaklir Genuair | aclidinium bromide/formoterol fumarate dihydrate | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/14/964 | Inhalation powder | R03AL05 | 21.11.2014 |
| 19.11.2014 | Ketoconazole HRA | ketoconazole | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | Tablet | Pending | 21.11.2014 |
| 19.11.2014 | Lymphoseek | tilmanocept | Navidea Biopharmaceuticals Limited
  30 Upper High Street Thame, OX9 3EZ United Kingdom | EU/1/14/955 | Kit for radiopharmaceutical preparation | V09IA09 | 21.11.2014 |
| 19.11.2014 | REZOLSTA | DARUNAVIR/COBICISTAT | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/967 | Film-coated tablet | J05AR14 | 21.11.2014 |
| 19.11.2014 | Vylaer Spiromax | budesonide/formoterol | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/949 | Inhalation powder | R03AK07 | 24.11.2014 |
| 21.11.2014 | Tadalafil Mylan | tadalafil | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/14/961 | Film-coated tablet | G04BE08 | 25.11.2014 |
| 21.11.2014 | Trulicity | dulaglutide | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/14/956 | Solution for injection | Pending | 25.11.2014 |
| 21.11.2014 | Vargatef | nintedanib | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | Capsule, soft | Pending | 25.11.2014 |

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

17.11.2014

Harvoni

ledipasvir/sofosbuvir

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

Film-coated tablet

Pending

18.11.2014

19.11.2014

Brimica Genuair

aclidinium bromide/formoterol fumarate dihydrate

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/14/963

Inhalation powder

R03AL05

21.11.2014

19.11.2014

Budesonide/Formoterol Teva

budesonide/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/948

Inhalation powder

R03AK07

24.11.2014

19.11.2014

Budesonide/Formoterol Teva Pharma B.V.

budesonide/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/950

Inhalation powder

R03AK07

21.11.2014

19.11.2014

Duaklir Genuair

aclidinium bromide/formoterol fumarate dihydrate

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/14/964

Inhalation powder

R03AL05

21.11.2014

19.11.2014

Ketoconazole HRA

ketoconazole

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

Tablet

Pending

21.11.2014

19.11.2014

Lymphoseek

tilmanocept

Navidea Biopharmaceuticals Limited

30 Upper High Street Thame, OX9 3EZ United Kingdom

EU/1/14/955

Kit for radiopharmaceutical preparation

V09IA09

21.11.2014

19.11.2014

REZOLSTA

DARUNAVIR/COBICISTAT

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/967

Film-coated tablet

J05AR14

21.11.2014

19.11.2014

Vylaer Spiromax

budesonide/formoterol

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/949

Inhalation powder

R03AK07

24.11.2014

21.11.2014

Tadalafil Mylan

tadalafil

Generics [UK] Limited

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

EU/1/14/961

Film-coated tablet

G04BE08

25.11.2014

21.11.2014

Trulicity

dulaglutide

Eli Lilly Nederland B.V.

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

EU/1/14/956

Solution for injection

Pending

25.11.2014

21.11.2014

Vargatef

nintedanib

Boehringer Ingelheim International GmbH

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

EU/1/14/954

Capsule, soft

Pending

25.11.2014

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.11.2014 | Arava | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/99/118 | 11.11.2014 |
| 7.11.2014 | Biograstim | AbZ-Pharma GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/08/450 | 11.11.2014 |
| 7.11.2014 | Inlyta | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/777 | 11.11.2014 |
| 7.11.2014 | Pioglitazone Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/722 | 11.11.2014 |
| 7.11.2014 | Prometax | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/98/092 | 11.11.2014 |
| 7.11.2014 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 12.11.2014 |
| 7.11.2014 | Xagrid | Shire Pharmaceutical Contracts Ltd
  Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom | EU/1/04/295 | 11.11.2014 |
| 11.11.2014 | Glidipion | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/12/756 | 13.11.2014 |
| 11.11.2014 | Imatinib Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/12/808 | 13.11.2014 |
| 11.11.2014 | Irbesartan/Hydrochlorothiazide Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/09/583 | 14.11.2014 |
| 11.11.2014 | Lamivudine/Zidovudine Teva | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/10/663 | 13.11.2014 |
| 11.11.2014 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/13/824 | 13.11.2014 |
| 11.11.2014 | Pioglitazone Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/12/755 | 13.11.2014 |
| 13.11.2014 | Neulasta | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/02/227 | 17.11.2014 |
| 13.11.2014 | NovoMix | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/00/142 | 17.11.2014 |
| 13.11.2014 | Ribavirin Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/509 | 17.11.2014 |
| 13.11.2014 | Ribavirin Teva Pharma BV | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/527 | 17.11.2014 |
| 13.11.2014 | Trisenox | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/02/204 | 17.11.2014 |
| 13.11.2014 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 17.11.2014 |
| 17.11.2014 | Avastin | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/04/300 | 19.11.2014 |
| 17.11.2014 | Fendrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/04/299 | 19.11.2014 |
| 17.11.2014 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 19.11.2014 |
| 17.11.2014 | Lamivudine Teva Pharma B.V. | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/596 | 20.11.2014 |
| 17.11.2014 | Revatio | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/05/318 | 19.11.2014 |
| 17.11.2014 | Tepadina | ADIENNE S.r.l.
  Via Galileo Galilei 19, 20867 Caponago (MB), Italia | EU/1/10/622 | 19.11.2014 |
| 17.11.2014 | Tygacil | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/06/336 | 19.11.2014 |
| 17.11.2014 | Zometa | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/01/176 | 19.11.2014 |
| 19.11.2014 | Aldurazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/03/253 | 20.11.2014 |
| 19.11.2014 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/13/838 | 21.11.2014 |
| 19.11.2014 | Betmiga | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/12/809 | 21.11.2014 |
| 19.11.2014 | Bretaris Genuair | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/12/781 | 21.11.2014 |
| 19.11.2014 | DuoCover | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 21.11.2014 |
| 19.11.2014 | DuoPlavin | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/619 | 21.11.2014 |
| 19.11.2014 | Eklira Genuair | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/12/778 | 21.11.2014 |
| 19.11.2014 | Evoltra | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/06/334 | 21.11.2014 |
| 19.11.2014 | Humira | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/03/256 | 21.11.2014 |
| 19.11.2014 | Imnovid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/13/850 | 21.11.2014 |
| 19.11.2014 | Kalydeco | Vertex Pharmaceuticals (U.K.) Limited
  Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom | EU/1/12/782 | 21.11.2014 |
| 19.11.2014 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 21.11.2014 |
| 19.11.2014 | Lojuxta | Aegerion Pharmaceuticals Limited
  Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom | EU/1/13/851 | 21.11.2014 |
| 19.11.2014 | Neupro | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/05/331 | 21.11.2014 |
| 19.11.2014 | Renagel | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/99/123 | 21.11.2014 |
| 19.11.2014 | Signifor | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/12/753 | 21.11.2014 |
| 19.11.2014 | Temozolomide HEXAL | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/10/616 | 21.11.2014 |
| 19.11.2014 | Temozolomide Sandoz | Sandoz Pharmaceuticals GmbH
  Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland | EU/1/10/617 | 21.11.2014 |
| 19.11.2014 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 21.11.2014 |
| 19.11.2014 | Valdoxan | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes CEDEX, France | EU/1/08/499 | 21.11.2014 |
| 19.11.2014 | Xaluprine | Nova Laboratories Limited
  Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom | EU/1/11/727 | 21.11.2014 |
| 19.11.2014 | ZALTRAP | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | 21.11.2014 |
| 21.11.2014 | Capecitabine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/761 | 25.11.2014 |
| 21.11.2014 | Cervarix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/07/419 | 25.11.2014 |
| 21.11.2014 | Docetaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/611 | 25.11.2014 |
| 21.11.2014 | Firmagon | Ferring Pharmaceuticals A/S
  Kay Fiskers Plads 11, DK-2300 København S, Danmark | EU/1/08/504 | 25.11.2014 |
| 21.11.2014 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 25.11.2014 |
| 21.11.2014 | Nexavar | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/06/342 | 25.11.2014 |
| 21.11.2014 | Repaglinide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/530 | 25.11.2014 |
| 21.11.2014 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/494 | 25.11.2014 |
| 21.11.2014 | Tafinlar | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/865 | 25.11.2014 |
| 28.11.2014 | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 2.12.2014 |
| 28.11.2014 | Cetrotide | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/99/100 | 2.12.2014 |
| 28.11.2014 | Firdapse | BioMarin Europe Ltd
  164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/09/601 | 2.12.2014 |
| 28.11.2014 | Topotecan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/552 | 2.12.2014 |
| 28.11.2014 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 2.12.2014 |

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

7.11.2014

Arava

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/99/118

11.11.2014

7.11.2014

Biograstim

AbZ-Pharma GmbH

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

EU/1/08/450

11.11.2014

7.11.2014

Inlyta

Pfizer Limited

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

EU/1/12/777

11.11.2014

7.11.2014

Pioglitazone Accord

Accord Healthcare Limited

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

EU/1/11/722

11.11.2014

7.11.2014

Prometax

Novartis Europharm Limited

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

EU/1/98/092

11.11.2014

7.11.2014

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

12.11.2014

7.11.2014

Xagrid

Shire Pharmaceutical Contracts Ltd

Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom

EU/1/04/295

11.11.2014

11.11.2014

Glidipion

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/12/756

13.11.2014

11.11.2014

Imatinib Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/12/808

13.11.2014

11.11.2014

Irbesartan/Hydrochlorothiazide Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/09/583

14.11.2014

11.11.2014

Lamivudine/Zidovudine Teva

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/10/663

13.11.2014

11.11.2014

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/13/824

13.11.2014

11.11.2014

Pioglitazone Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/12/755

13.11.2014

13.11.2014

Neulasta

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/02/227

17.11.2014

13.11.2014

NovoMix

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/00/142

17.11.2014

13.11.2014

Ribavirin Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/509

17.11.2014

13.11.2014

Ribavirin Teva Pharma BV

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/527

17.11.2014

13.11.2014

Trisenox

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/02/204

17.11.2014

13.11.2014

Tysabri

Biogen Idec Limited

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

EU/1/06/346

17.11.2014

17.11.2014

Avastin

Roche Registration Limited

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

EU/1/04/300

19.11.2014

17.11.2014

Fendrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/04/299

19.11.2014

17.11.2014

Kivexa

ViiV Healthcare UK Limited

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

EU/1/04/298

19.11.2014

17.11.2014

Lamivudine Teva Pharma B.V.

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/596

20.11.2014

17.11.2014

Revatio

Pfizer Limited

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

EU/1/05/318

19.11.2014

17.11.2014

Tepadina

ADIENNE S.r.l.

Via Galileo Galilei 19, 20867 Caponago (MB), Italia

EU/1/10/622

19.11.2014

17.11.2014

Tygacil

Pfizer Limited

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

EU/1/06/336

19.11.2014

17.11.2014

Zometa

Novartis Europharm Limited

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

EU/1/01/176

19.11.2014

19.11.2014

Aldurazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/03/253

20.11.2014

19.11.2014

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

21.11.2014

19.11.2014

Betmiga

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/12/809

21.11.2014

19.11.2014

Bretaris Genuair

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/781

21.11.2014

19.11.2014

DuoCover

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

21.11.2014

19.11.2014

DuoPlavin

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/10/619

21.11.2014

19.11.2014

Eklira Genuair

Almirall, S.A.

Ronda General Mitre, 151, E-08022 Barcelona, España

EU/1/12/778

21.11.2014

19.11.2014

Evoltra

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/06/334

21.11.2014

19.11.2014

Humira

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

21.11.2014

19.11.2014

Imnovid

Celgene Europe Limited

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

EU/1/13/850

21.11.2014

19.11.2014

Kalydeco

Vertex Pharmaceuticals (U.K.) Limited

Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom

EU/1/12/782

21.11.2014

19.11.2014

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

21.11.2014

19.11.2014

Lojuxta

Aegerion Pharmaceuticals Limited

Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom

EU/1/13/851

21.11.2014

19.11.2014

Neupro

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

21.11.2014

19.11.2014

Renagel

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/99/123

21.11.2014

19.11.2014

Signifor

Novartis Europharm Limited

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

EU/1/12/753

21.11.2014

19.11.2014

Temozolomide HEXAL

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/10/616

21.11.2014

19.11.2014

Temozolomide Sandoz

Sandoz Pharmaceuticals GmbH

Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland

EU/1/10/617

21.11.2014

19.11.2014

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

21.11.2014

19.11.2014

Valdoxan

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes CEDEX, France

EU/1/08/499

21.11.2014

19.11.2014

Xaluprine

Nova Laboratories Limited

Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom

EU/1/11/727

21.11.2014

19.11.2014

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

21.11.2014

21.11.2014

Capecitabine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/761

25.11.2014

21.11.2014

Cervarix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/07/419

25.11.2014

21.11.2014

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

25.11.2014

21.11.2014

Firmagon

Ferring Pharmaceuticals A/S

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

EU/1/08/504

25.11.2014

21.11.2014

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

25.11.2014

21.11.2014

Nexavar

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/06/342

25.11.2014

21.11.2014

Repaglinide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/530

25.11.2014

21.11.2014

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

25.11.2014

21.11.2014

Tafinlar

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/865

25.11.2014

28.11.2014

Brinavess

Cardiome UK Limited

Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom

EU/1/10/645

2.12.2014

28.11.2014

Cetrotide

Merck Serono Europe Limited

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

EU/1/99/100

2.12.2014

28.11.2014

Firdapse

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/09/601

2.12.2014

28.11.2014

Topotecan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/552

2.12.2014

28.11.2014

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

2.12.2014

—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Suspension of a marketing authorisation

| 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 |
| --- | --- | --- | --- | --- |
| 19.11.2014 | MACI | Aastrom Biosciences DK ApS
  Oliefabriksvej 45, 2770 Kastrup, Danmark | EU/1/13/847 | 24.11.2014 |

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

19.11.2014

MACI

Aastrom Biosciences DK ApS

Oliefabriksvej 45, 2770 Kastrup, Danmark

EU/1/13/847

24.11.2014

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

Issuing of a marketing authorisation

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 7.11.2014 | Porcilis PCV M Hyo | Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated) | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/14/175 | Emulsion for injection | QI09AL | 11.11.2014 |

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

7.11.2014

Porcilis PCV M Hyo

Porcine circovirus and Mycoplasma hyopneumoniae vaccine (inactivated)

Mycoplasma hyopneumoniae

Intervet International B.V.

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

EU/2/14/175

Emulsion for injection

QI09AL

11.11.2014

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

Modification of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | Holder of the marketing authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 7.11.2014 | Zolvix | Novartis Healthcare A/S
  Edvard Thomsens Vej 14, DK-2300 København S, Danmark | EU/2/09/101 | 11.11.2014 |
| 7.11.2014 | Zulvac 8 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/105 | 12.11.2014 |
| 7.11.2014 | Zulvac 8 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/09/104 | 12.11.2014 |
| 28.11.2014 | ProZinc | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/13/152 | 2.12.2014 |
| 28.11.2014 | Semintra | Boehringer Ingelheim Vetmedica GmbH
  D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/146 | 2.12.2014 |

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

7.11.2014

Zolvix

Novartis Healthcare A/S

Edvard Thomsens Vej 14, DK-2300 København S, Danmark

EU/2/09/101

11.11.2014

7.11.2014

Zulvac 8 Bovis

Zoetis Belgium S.A.

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

EU/2/09/105

12.11.2014

7.11.2014

Zulvac 8 Ovis

Zoetis Belgium S.A.

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

EU/2/09/104

12.11.2014

28.11.2014

ProZinc

Boehringer Ingelheim Vetmedica GmbH

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

EU/2/13/152

2.12.2014

28.11.2014

Semintra

Boehringer Ingelheim Vetmedica GmbH

D-55216 Ingelheim am Rhein, Deutschland

EU/2/12/146

2.12.2014

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, 30.4.2004, p. 1.

1

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

2

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