# Official Journal C 438/25 N

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 438 |
| | |
| English edition | Information and Notices | Volume 5925 November 2016 |

ISSN 1977-091X

Official Journal

of the European Union

C 438

English edition

Information and Notices

Volume 5925 November 2016

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2016/C 438/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2016 to 31 October 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2016/C 438/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 October 2016 to 31 October 2016(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

---

| EN | |
| --- | --- |

EN

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 25.11.2016 | EN | Official Journal of the European Union | C 438/1 |
| --- | --- | --- | --- |

25.11.2016

EN

Official Journal of the European Union

C 438/1

---

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

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

(2016/C 438/01)

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

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.10.2016 | Onivyde | irinotecan | Baxalta Innovations GmbH
  Industriestrasse 67, A-1221 Wien, Österreich | EU/1/16/1130 | Concentrate for solution for infusion | L01XX19 | 18.10.2016 |

Date of the decision

Name of the medicinal product

INN (International Non-Proprietary Name)

Holder of the marketing authorisation

Number of the entry in the Community Register

Pharmaceutical form

ATC code (Anatomical Therapeutic Chemical Code)

Date of notification

14.10.2016

Onivyde

irinotecan

Baxalta Innovations GmbH

Industriestrasse 67, A-1221 Wien, Österreich

EU/1/16/1130

Concentrate for solution for infusion

L01XX19

18.10.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.10.2016 | Imatinib Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/808 | 10.10.2016 |
| 6.10.2016 | Pregabalin Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1011 | 10.10.2016 |
| 6.10.2016 | Replagal | Shire Human Genetic Therapies AB
  Vasagatan 7, 111 20 Stockholm, Sverige | EU/1/01/189 | 10.10.2016 |
| 14.10.2016 | Leflunomide Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/09/604 | 18.10.2016 |
| 14.10.2016 | Lixiana | Daiichi Sankyo Europe GmbH
  Zielstattstrasse 48, D-81379 München, Deutschland | EU/1/15/993 | 18.10.2016 |
| 14.10.2016 | Pegasys | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/221 | 26.10.2016 |
| 14.10.2016 | Ristempa | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/996 | 18.10.2016 |
| 14.10.2016 | Stivarga | Bayer Pharma AG
  D-13342 Berlin, Deutschland | EU/1/13/858 | 18.10.2016 |
| 14.10.2016 | Zerbaxa | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1032 | 18.10.2016 |
| 21.10.2016 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 25.10.2016 |
| 21.10.2016 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 25.10.2016 |
| 21.10.2016 | Blincyto | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1047 | 25.10.2016 |
| 21.10.2016 | Cholib | Mylan Products Limited
  20 Station Close, Potters Bar, EN6 ITL, United Kingdom | EU/1/13/866 | 25.10.2016 |
| 21.10.2016 | Lynparza | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/959 | 25.10.2016 |
| 21.10.2016 | Metalyse | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/00/169 | 25.10.2016 |
| 21.10.2016 | NovoRapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/99/119 | 25.10.2016 |
| 21.10.2016 | Olanzapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/07/427 | 25.10.2016 |
| 21.10.2016 | Prevenar 13 | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/09/590 | 25.10.2016 |
| 24.10.2016 | Evicel | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/08/473 | 26.10.2016 |
| 24.10.2016 | Raplixa | ProFibrix BV (Mallinckrodt Pharmaceuticals)
  Darwinweg 24 2333 CR Leiden, Nederland | EU/1/14/985 | 26.10.2016 |
| 24.10.2016 | Somatropin Biopartners | BioPartners GmbH
  Kaiserpassage 11, D-72764 Reutlingen, Deutschland | EU/1/13/849 | 26.10.2016 |
| 24.10.2016 | ZALTRAP | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | 26.10.2016 |
| 27.10.2016 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 31.10.2016 |
| 27.10.2016 | Privigen | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/08/446 | 31.10.2016 |
| 27.10.2016 | Vitekta | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/883 | 31.10.2016 |
| 27.10.2016 | Volibris | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/08/451 | 31.10.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

6.10.2016

Imatinib Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/808

10.10.2016

6.10.2016

Pregabalin Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1011

10.10.2016

6.10.2016

Replagal

Shire Human Genetic Therapies AB

Vasagatan 7, 111 20 Stockholm, Sverige

EU/1/01/189

10.10.2016

14.10.2016

Leflunomide Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/09/604

18.10.2016

14.10.2016

Lixiana

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48, D-81379 München, Deutschland

EU/1/15/993

18.10.2016

14.10.2016

Pegasys

Roche Registration Limited

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

EU/1/02/221

26.10.2016

14.10.2016

Ristempa

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/996

18.10.2016

14.10.2016

Stivarga

Bayer Pharma AG

D-13342 Berlin, Deutschland

EU/1/13/858

18.10.2016

14.10.2016

Zerbaxa

Merck Sharp & Dohme Limited

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

EU/1/15/1032

18.10.2016

21.10.2016

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

25.10.2016

21.10.2016

BeneFIX

Pfizer Limited

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

EU/1/97/047

25.10.2016

21.10.2016

Blincyto

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1047

25.10.2016

21.10.2016

Cholib

Mylan Products Limited

20 Station Close, Potters Bar, EN6 ITL, United Kingdom

EU/1/13/866

25.10.2016

21.10.2016

Lynparza

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/959

25.10.2016

21.10.2016

Metalyse

Boehringer Ingelheim International GmbH

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

EU/1/00/169

25.10.2016

21.10.2016

NovoRapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/99/119

25.10.2016

21.10.2016

Olanzapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/07/427

25.10.2016

21.10.2016

Prevenar 13

Pfizer Limited

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

EU/1/09/590

25.10.2016

24.10.2016

Evicel

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/08/473

26.10.2016

24.10.2016

Raplixa

ProFibrix BV (Mallinckrodt Pharmaceuticals)

Darwinweg 24 2333 CR Leiden, Nederland

EU/1/14/985

26.10.2016

24.10.2016

Somatropin Biopartners

BioPartners GmbH

Kaiserpassage 11, D-72764 Reutlingen, Deutschland

EU/1/13/849

26.10.2016

24.10.2016

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

26.10.2016

27.10.2016

Perjeta

Roche Registration Limited

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

EU/1/13/813

31.10.2016

27.10.2016

Privigen

CSL Behring GmbH

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

EU/1/08/446

31.10.2016

27.10.2016

Vitekta

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/883

31.10.2016

27.10.2016

Volibris

Glaxo Group Ltd

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

EU/1/08/451

31.10.2016

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

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 3.10.2016 | Hiprabovis IBR Marker Live | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170 Amer (Girona), España | EU/2/10/114 | 5.10.2016 |
| 3.10.2016 | Meloxidyl | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/06/070 | 5.10.2016 |

Date of the decision

Name of the medicinal product

Holder of the marketing authorisation

Number of the entry in the Community Register

Date of notification

3.10.2016

Hiprabovis IBR Marker Live

Laboratorios Hipra, S.A.

Avda. La Selva, 135, E-17170 Amer (Girona), España

EU/2/10/114

5.10.2016

3.10.2016

Meloxidyl

CEVA SANTE ANIMALE

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

EU/2/06/070

5.10.2016

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

| European Medicines Agency |
| --- |
| 30 Churchill Place |
| Canary Wharf |
| London E14 5EU |
| United Kingdom |

European Medicines Agency

30 Churchill Place

Canary Wharf

London E14 5EU

United Kingdom

---

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

---