# C_2015285EN.01000101.xml

| 28.8.2015 | EN | Official Journal of the European Union | C 285/1 |
| --- | --- | --- | --- |

28.8.2015

EN

Official Journal of the European Union

C 285/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2015 to 31 July 2015

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

1

(2015/C 285/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.7.2015 | Hetlioz | tasimelteon | Vanda Pharmaceuticals Limited
  222 Regent Street, London W1B 5TR, United Kingdom | EU/1/15/1008 | Capsule, hard | N05CH03 | 7.7.2015 |
| 13.7.2015 | EVOTAZ | atazanavir/cobicistat | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | Film-coated tablet | J05AR15 | 15.7.2015 |
| 17.7.2015 | KEYTRUDA | pembrolizumab | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | Powder for concentrate for solution for infusion | L01XC18 | 21.7.2015 |
| 17.7.2015 | Pregabalin Zentiva | pregabalin | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1021 | Capsule, hard | N03AX16 | 21.7.2015 |
| 17.7.2015 | Repatha | evolocumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1016 | Solution for injection in a pre-filled syringe | C10AX13 | 21.7.2015 |
| 20.7.2015 | Bortezomib Accord | bortezomib | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1019 | Powder for solution for injection | L01XX32 | 23.7.2015 |
| 20.7.2015 | Nivolumab BMS | nivolumab | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1026 | Concentrate for solution for infusion | L01XC17 | 23.7.2015 |
| 28.7.2015 | Omidria | phenylephrine/ketorolac | Omeros London Limited
  Berkeley Square, London, W1J 6BD, United Kingdom | EU/1/15/1018 | Concentrate for solution for intraocular irrigation | Pending | 30.7.2015 |

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

3.7.2015

Hetlioz

tasimelteon

Vanda Pharmaceuticals Limited

222 Regent Street, London W1B 5TR, United Kingdom

EU/1/15/1008

Capsule, hard

N05CH03

7.7.2015

13.7.2015

EVOTAZ

atazanavir/cobicistat

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

Film-coated tablet

J05AR15

15.7.2015

17.7.2015

KEYTRUDA

pembrolizumab

Merck Sharp & Dohme Limited

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

EU/1/15/1024

Powder for concentrate for solution for infusion

L01XC18

21.7.2015

17.7.2015

Pregabalin Zentiva

pregabalin

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1021

Capsule, hard

N03AX16

21.7.2015

17.7.2015

Repatha

evolocumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1016

Solution for injection in a pre-filled syringe

C10AX13

21.7.2015

20.7.2015

Bortezomib Accord

bortezomib

Accord Healthcare Limited

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

EU/1/15/1019

Powder for solution for injection

L01XX32

23.7.2015

20.7.2015

Nivolumab BMS

nivolumab

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1026

Concentrate for solution for infusion

L01XC17

23.7.2015

28.7.2015

Omidria

phenylephrine/ketorolac

Omeros London Limited

Berkeley Square, London, W1J 6BD, United Kingdom

EU/1/15/1018

Concentrate for solution for intraocular irrigation

Pending

30.7.2015

—   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 |
| --- | --- | --- | --- | --- |
| 3.7.2015 | Lympreva | Biovest Europe Limited
  Evershed House, 70 Great Bridgewater St., Manchester M1 5ES, United Kingdom | — | 7.7.2015 |

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

3.7.2015

Lympreva

Biovest Europe Limited

Evershed House, 70 Great Bridgewater St., Manchester M1 5ES, United Kingdom

—

7.7.2015

—   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 |
| --- | --- | --- | --- | --- |
| 3.7.2015 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 7.7.2015 |
| 3.7.2015 | Bemfola | FINOX Biotech AG
  Gewerbestrasse 7, FL-9496 Balzers, Liechtenstein | EU/1/13/909 | 8.7.2015 |
| 3.7.2015 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 7.7.2015 |
| 3.7.2015 | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 7.7.2015 |
| 3.7.2015 | Docetaxel Kabi | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/12/770 | 7.7.2015 |
| 3.7.2015 | Fampyra | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/11/699 | 7.7.2015 |
| 3.7.2015 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 7.7.2015 |
| 3.7.2015 | Hemangiol | Pierre Fabre Dermatologie
  45 place Abel Gance, F-92100 Boulogne, France | EU/1/14/919 | 7.7.2015 |
| 3.7.2015 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 7.7.2015 |
| 3.7.2015 | Neuraceq | Piramal Imaging Limited
  Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom | EU/1/13/906 | 7.7.2015 |
| 3.7.2015 | Pradaxa | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/08/442 | 7.7.2015 |
| 3.7.2015 | Viramune | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/055 | 7.7.2015 |
| 3.7.2015 | Zoledronic acid medac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/12/779 | 7.7.2015 |
| 3.7.2015 | Zometa | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/01/176 | 7.7.2015 |
| 8.7.2015 | Ambirix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/02/224 | 10.7.2015 |
| 8.7.2015 | CONTROLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/515 | 10.7.2015 |
| 8.7.2015 | DuoResp Spiromax | Teva Pharma B.V.
  Computerweg 10, NL-3542 DR Utrecht, Nederland | EU/1/14/920 | 13.7.2015 |
| 8.7.2015 | Flebogamma DIF | Instituto Grifols, S.A.
  Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa | EU/1/07/404 | 10.7.2015 |
| 8.7.2015 | Foscan | biolitec pharma ltd.
  Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland. | EU/1/01/197 | 10.7.2015 |
| 8.7.2015 | Iasibon | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/10/659 | 10.7.2015 |
| 8.7.2015 | Mimpara | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/04/292 | 10.7.2015 |
| 8.7.2015 | PANTECTA Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/518 | 10.7.2015 |
| 8.7.2015 | PANTOLOC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/519 | 10.7.2015 |
| 8.7.2015 | PANTOZOL Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/517 | 10.7.2015 |
| 8.7.2015 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 10.7.2015 |
| 8.7.2015 | Pregabalin Pfizer | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/14/916 | 10.7.2015 |
| 8.7.2015 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 10.7.2015 |
| 8.7.2015 | Remicade | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/99/116 | 10.7.2015 |
| 8.7.2015 | SOMAC Control | Takeda GmbH, (HRB 701016)
  Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland | EU/1/09/516 | 10.7.2015 |
| 8.7.2015 | Tandemact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/366 | 10.7.2015 |
| 8.7.2015 | Vaniqa | Almirall, S.A.
  Ronda General Mitre, 151, E-08022 Barcelona, España | EU/1/01/173 | 10.7.2015 |
| 8.7.2015 | Vimizim | BioMarin Europe Ltd
  164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom | EU/1/14/914 | 10.7.2015 |
| 8.7.2015 | Yttriga | Eckert & Ziegler Radiopharma GmbH
  Robert-Rössle-Str. 10, D-13125 Berlin, Deutschland | EU/1/05/322 | 10.7.2015 |
| 13.7.2015 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 15.7.2015 |
| 13.7.2015 | Zoledronic acid Teva Generics | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/912 | 15.7.2015 |
| 17.7.2015 | Aflunov | Novartis Vaccines Influenza S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/658 | 22.7.2015 |
| 17.7.2015 | Brilique | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/10/655 | 21.7.2015 |
| 17.7.2015 | Circadin | RAD Neurim Pharmaceuticals EEC Limited
  One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom | EU/1/07/392 | 21.7.2015 |
| 17.7.2015 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 21.7.2015 |
| 17.7.2015 | HALAVEN | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/11/678 | 21.7.2015 |
| 17.7.2015 | JETREA | ThromboGenics NV
  Gaston Geenslaan 1, B-3001 Leuven, België | EU/1/13/819 | 22.7.2015 |
| 17.7.2015 | Latuda | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/913 | 21.7.2015 |
| 17.7.2015 | PecFent | Archimedes Development Ltd
  Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom | EU/1/10/644 | 21.7.2015 |
| 17.7.2015 | Rapiscan | Rapidscan Pharma Solutions EU Ltd
  Regent’s Place, 338 Euston Road, London NW1 3BT, United Kingdom | EU/1/10/643 | 21.7.2015 |
| 17.7.2015 | RoActemra | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/08/492 | 21.7.2015 |
| 17.7.2015 | Somavert | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/02/240 | 21.7.2015 |
| 17.7.2015 | Sylvant | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/928 | 22.7.2015 |
| 17.7.2015 | Votrient | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/628 | 21.7.2015 |
| 17.7.2015 | XALKORI | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/793 | 21.7.2015 |
| 20.7.2015 | Lucentis | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/374 | 23.7.2015 |
| 20.7.2015 | Replagal | Shire Human Genetic Therapies AB
  Svärdvägen 11D, SE-182 33 Danderyd, Sverige | EU/1/01/189 | 23.7.2015 |
| 20.7.2015 | Soliris | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/07/393 | 23.7.2015 |
| 28.7.2015 | Abraxane | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom | EU/1/07/428 | 30.7.2015 |
| 28.7.2015 | Brinavess | Cardiome UK Limited
  Lakeside House, 1 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB11 1BD, United Kingdom | EU/1/10/645 | 30.7.2015 |
| 28.7.2015 | Humira | AbbVie Ltd
  Maidenhead, SL6 4XE, United Kingdom | EU/1/03/256 | 30.7.2015 |
| 28.7.2015 | Lantus | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/00/134 | 30.7.2015 |
| 28.7.2015 | Levemir | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/04/278 | 30.7.2015 |
| 28.7.2015 | Mycamine | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/08/448 | 30.7.2015 |
| 28.7.2015 | Neoclarityn | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/161 | 31.7.2015 |
| 28.7.2015 | Nimenrix | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/12/767 | 31.7.2015 |
| 28.7.2015 | Opsumit | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/13/893 | 30.7.2015 |
| 28.7.2015 | Osigraft | Olympus Biotech International Limited
  40 Upper Mount Street, Dublin 2, Ireland | EU/1/01/179 | 30.7.2015 |
| 28.7.2015 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 30.7.2015 |
| 28.7.2015 | Prepandemic Influenza | Novartis Vaccines and Diagnostics S.r.l.
  Via Fiorentina, 1, 53100 Siena, Italia | EU/1/10/657 | 31.7.2015 |
| 28.7.2015 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 30.7.2015 |
| 28.7.2015 | Temomedac | medac Gesellschaft für klinische Spezialpräparate mbH
  Theaterstr. 6, D-22880 Wedel, Deutschland | EU/1/09/605 | 30.7.2015 |
| 28.7.2015 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/697 | 30.7.2015 |
| 28.7.2015 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 30.7.2015 |
| 28.7.2015 | Translarna | PTC Therapeutics International Limited
  77 Sir John Rogerson’s Quay, Dublin 2, Ireland | EU/1/13/902 | 30.7.2015 |
| 28.7.2015 | Vizarsin | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/551 | 31.7.2015 |
| 28.7.2015 | Votubia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/710 | 30.7.2015 |
| 28.7.2015 | Xarelto | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/08/472 | 30.7.2015 |
| 28.7.2015 | Zebinix | BIAL — Portela & Ca, SA
  A Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal | EU/1/09/514 | 30.7.2015 |
| 28.7.2015 | Zytiga | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/11/714 | 30.7.2015 |
| 29.7.2015 | Glubrava | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/07/421 | 31.7.2015 |
| 29.7.2015 | Ketek | Aventis Pharma S.A.
  20, Avenue Raymond Aron, F-92160 ANTONY, France | EU/1/01/191 | 31.7.2015 |
| 31.7.2015 | Abseamed | Medice Arzneimittel Pütter GmbH & Co KG
  Kuhloweg 37, D-58638 Iserlohn, Deutschland | EU/1/07/412 | 4.8.2015 |
| 31.7.2015 | Binocrit | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/07/410 | 4.8.2015 |
| 31.7.2015 | Epoetin alfa Hexal | Hexal AG
  Industriestrasse 25, D-83607 Holzkirchen, Deutschland | EU/1/07/411 | 4.8.2015 |
| 31.7.2015 | Picato | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | 4.8.2015 |
| 31.7.2015 | Voncento | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/13/857 | 4.8.2015 |

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

3.7.2015

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

7.7.2015

3.7.2015

Bemfola

FINOX Biotech AG

Gewerbestrasse 7, FL-9496 Balzers, Liechtenstein

EU/1/13/909

8.7.2015

3.7.2015

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

7.7.2015

3.7.2015

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

7.7.2015

3.7.2015

Docetaxel Kabi

Fresenius Kabi Oncology Plc.

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

EU/1/12/770

7.7.2015

3.7.2015

Fampyra

Biogen Idec Limited

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

EU/1/11/699

7.7.2015

3.7.2015

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

7.7.2015

3.7.2015

Hemangiol

Pierre Fabre Dermatologie

45 place Abel Gance, F-92100 Boulogne, France

EU/1/14/919

7.7.2015

3.7.2015

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

7.7.2015

3.7.2015

Neuraceq

Piramal Imaging Limited

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

EU/1/13/906

7.7.2015

3.7.2015

Pradaxa

Boehringer Ingelheim International GmbH

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

EU/1/08/442

7.7.2015

3.7.2015

Viramune

Boehringer Ingelheim International GmbH

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

EU/1/97/055

7.7.2015

3.7.2015

Zoledronic acid medac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/12/779

7.7.2015

3.7.2015

Zometa

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/01/176

7.7.2015

8.7.2015

Ambirix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/02/224

10.7.2015

8.7.2015

CONTROLOC Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/515

10.7.2015

8.7.2015

DuoResp Spiromax

Teva Pharma B.V.

Computerweg 10, NL-3542 DR Utrecht, Nederland

EU/1/14/920

13.7.2015

8.7.2015

Flebogamma DIF

Instituto Grifols, S.A.

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

EU/1/07/404

10.7.2015

8.7.2015

Foscan

biolitec pharma ltd.

Unit 9A, Plato Business Park, Damastown, Dublin 15, Ireland.

EU/1/01/197

10.7.2015

8.7.2015

Iasibon

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/10/659

10.7.2015

8.7.2015

Mimpara

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/04/292

10.7.2015

8.7.2015

PANTECTA Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/518

10.7.2015

8.7.2015

PANTOLOC Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/519

10.7.2015

8.7.2015

PANTOZOL Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/517

10.7.2015

8.7.2015

Perjeta

Roche Registration Limited

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

EU/1/13/813

10.7.2015

8.7.2015

Pregabalin Pfizer

Pfizer Limited

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

EU/1/14/916

10.7.2015

8.7.2015

Ranexa

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462

10.7.2015

8.7.2015

Remicade

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/99/116

10.7.2015

8.7.2015

SOMAC Control

Takeda GmbH, (HRB 701016)

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

EU/1/09/516

10.7.2015

8.7.2015

Tandemact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/366

10.7.2015

8.7.2015

Vaniqa

Almirall, S.A.

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

EU/1/01/173

10.7.2015

8.7.2015

Vimizim

BioMarin Europe Ltd

164 Shaftesbury Avenue, London WC2H 8HL, United Kingdom

EU/1/14/914

10.7.2015

8.7.2015

Yttriga

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10, D-13125 Berlin, Deutschland

EU/1/05/322

10.7.2015

13.7.2015

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

15.7.2015

13.7.2015

Zoledronic acid Teva Generics

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/912

15.7.2015

17.7.2015

Aflunov

Novartis Vaccines Influenza S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/658

22.7.2015

17.7.2015

Brilique

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/10/655

21.7.2015

17.7.2015

Circadin

RAD Neurim Pharmaceuticals EEC Limited

One Forbury Square, The Forbury, Reading, Berkshire RG1 3EB, United Kingdom

EU/1/07/392

21.7.2015

17.7.2015

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

21.7.2015

17.7.2015

HALAVEN

Eisai Europe Limited

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

EU/1/11/678

21.7.2015

17.7.2015

JETREA

ThromboGenics NV

Gaston Geenslaan 1, B-3001 Leuven, België

EU/1/13/819

22.7.2015

17.7.2015

Latuda

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/913

21.7.2015

17.7.2015

PecFent

Archimedes Development Ltd

Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom

EU/1/10/644

21.7.2015

17.7.2015

Rapiscan

Rapidscan Pharma Solutions EU Ltd

Regent’s Place, 338 Euston Road, London NW1 3BT, United Kingdom

EU/1/10/643

21.7.2015

17.7.2015

RoActemra

Roche Registration Limited

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

EU/1/08/492

21.7.2015

17.7.2015

Somavert

Pfizer Limited

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

EU/1/02/240

21.7.2015

17.7.2015

Sylvant

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/928

22.7.2015

17.7.2015

Votrient

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/628

21.7.2015

17.7.2015

XALKORI

Pfizer Limited

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

EU/1/12/793

21.7.2015

20.7.2015

Lucentis

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/374

23.7.2015

20.7.2015

Replagal

Shire Human Genetic Therapies AB

Svärdvägen 11D, SE-182 33 Danderyd, Sverige

EU/1/01/189

23.7.2015

20.7.2015

Soliris

Alexion Europe SAS

1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France

EU/1/07/393

23.7.2015

28.7.2015

Abraxane

Celgene Europe Limited

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

EU/1/07/428

30.7.2015

28.7.2015

Brinavess

Cardiome UK Limited

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

EU/1/10/645

30.7.2015

28.7.2015

Humira

AbbVie Ltd

Maidenhead, SL6 4XE, United Kingdom

EU/1/03/256

30.7.2015

28.7.2015

Lantus

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/00/134

30.7.2015

28.7.2015

Levemir

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/04/278

30.7.2015

28.7.2015

Mycamine

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/08/448

30.7.2015

28.7.2015

Neoclarityn

Merck Sharp & Dohme Limited

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

EU/1/00/161

31.7.2015

28.7.2015

Nimenrix

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/12/767

31.7.2015

28.7.2015

Opsumit

Actelion Registration Ltd

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

EU/1/13/893

30.7.2015

28.7.2015

Osigraft

Olympus Biotech International Limited

40 Upper Mount Street, Dublin 2, Ireland

EU/1/01/179

30.7.2015

28.7.2015

Perjeta

Roche Registration Limited

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

EU/1/13/813

30.7.2015

28.7.2015

Prepandemic Influenza

Novartis Vaccines and Diagnostics S.r.l.

Via Fiorentina, 1, 53100 Siena, Italia

EU/1/10/657

31.7.2015

28.7.2015

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

30.7.2015

28.7.2015

Temomedac

medac Gesellschaft für klinische Spezialpräparate mbH

Theaterstr. 6, D-22880 Wedel, Deutschland

EU/1/09/605

30.7.2015

28.7.2015

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/697

30.7.2015

28.7.2015

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

30.7.2015

28.7.2015

Translarna

PTC Therapeutics International Limited

77 Sir John Rogerson’s Quay, Dublin 2, Ireland

EU/1/13/902

30.7.2015

28.7.2015

Vizarsin

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/551

31.7.2015

28.7.2015

Votubia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/710

30.7.2015

28.7.2015

Xarelto

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/08/472

30.7.2015

28.7.2015

Zebinix

BIAL — Portela & Ca, SA

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

EU/1/09/514

30.7.2015

28.7.2015

Zytiga

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/11/714

30.7.2015

29.7.2015

Glubrava

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/07/421

31.7.2015

29.7.2015

Ketek

Aventis Pharma S.A.

20, Avenue Raymond Aron, F-92160 ANTONY, France

EU/1/01/191

31.7.2015

31.7.2015

Abseamed

Medice Arzneimittel Pütter GmbH & Co KG

Kuhloweg 37, D-58638 Iserlohn, Deutschland

EU/1/07/412

4.8.2015

31.7.2015

Binocrit

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/07/410

4.8.2015

31.7.2015

Epoetin alfa Hexal

Hexal AG

Industriestrasse 25, D-83607 Holzkirchen, Deutschland

EU/1/07/411

4.8.2015

31.7.2015

Picato

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

4.8.2015

31.7.2015

Voncento

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/13/857

4.8.2015

—   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 |
| --- | --- | --- | --- | --- |
| 3.7.2015 | Sonata | Meda AB
  Pipers väg 2A, S-170 09 Solna, Sverige | EU/1/99/102 | 7.7.2015 |
| 13.7.2015 | Zoledronic acid Teva Generics | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/14/912 | 15.7.2015 |

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

3.7.2015

Sonata

Meda AB

Pipers väg 2A, S-170 09 Solna, Sverige

EU/1/99/102

7.7.2015

13.7.2015

Zoledronic acid Teva Generics

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/14/912

15.7.2015

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.7.2015 | Canigen L4 | Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/183 | Suspension for injection | QI07AB01 | 7.7.2015 |
| 3.7.2015 | Innovax-ILT | Live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/182 | Suspension and solvent for suspension for injection | QI01AD | 7.7.2015 |
| 31.7.2015 | UpCard | Torasemide | Vétoquinol SA
  Magny-Vernois, 70200 Lure, France | EU/2/15/184 | Tablet | QC03CA04 | 4.8.2015 |

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

3.7.2015

Canigen L4

Leptospira interrogans serogroup Canicola serovar Portland-vere/Leptospira interrogans serogroup Icterohaemorrhagiae serovar Copenhageni/Leptospira interrogans serogroup Australis serovar Bratislava/Leptospira kirschneri serogroup Grippotyphosa serovar Dadas

Intervet International B.V.

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

EU/2/15/183

Suspension for injection

QI07AB01

7.7.2015

3.7.2015

Innovax-ILT

Live recombinant turkey herpesvirus (strain HVT/ILT-138), expressing the glycoproteins gD and gI of infectious laryngotracheitis virus

Intervet International B.V.

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

EU/2/15/182

Suspension and solvent for suspension for injection

QI01AD

7.7.2015

31.7.2015

UpCard

Torasemide

Vétoquinol SA

Magny-Vernois, 70200 Lure, France

EU/2/15/184

Tablet

QC03CA04

4.8.2015

—   Issuing of a marketing authorization (Article 38 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 |
| --- | --- | --- | --- | --- |
| 8.7.2015 | Lodipressin | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | — | 10.7.2015 |

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

8.7.2015

Lodipressin

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

—

10.7.2015

—   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 |
| --- | --- | --- | --- | --- |
| 13.7.2015 | SevoFlo | Abbott Laboratories Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead Berkshire SL6 4XE, United Kingdom | EU/2/02/035 | 15.7.2015 |
| 17.7.2015 | Incurin | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/00/018 | 21.7.2015 |
| 20.7.2015 | Contacera | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/144 | 23.7.2015 |
| 28.7.2015 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/140 | 30.7.2015 |
| 31.7.2015 | BTVPUR AlSap 2-4 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/108 | 4.8.2015 |
| 31.7.2015 | Coxevac | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/10/110 | 4.8.2015 |

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

13.7.2015

SevoFlo

Abbott Laboratories Ltd

Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead Berkshire SL6 4XE, United Kingdom

EU/2/02/035

15.7.2015

17.7.2015

Incurin

Intervet International B.V.

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

EU/2/00/018

21.7.2015

20.7.2015

Contacera

Zoetis Belgium S.A.

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

EU/2/12/144

23.7.2015

28.7.2015

Poulvac E. coli

Zoetis Belgium S.A.

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

EU/2/12/140

30.7.2015

31.7.2015

BTVPUR AlSap 2-4

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/108

4.8.2015

31.7.2015

Coxevac

CEVA SANTE ANIMALE

10 avenue de la Ballastière, F-33500 Libourne, France

EU/2/10/110

4.8.2015

—   Withdrawal of a marketing authorization (Article 38 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 |
| --- | --- | --- | --- | --- |
| 8.7.2015 | ProMeris | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/06/064 | 10.7.2015 |
| 8.7.2015 | ProMeris Duo | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/2/06/065 | 10.7.2015 |

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

8.7.2015

ProMeris

Pfizer Limited

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

EU/2/06/064

10.7.2015

8.7.2015

ProMeris Duo

Pfizer Limited

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

EU/2/06/065

10.7.2015

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

---

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

1

---