# C_2016189EN.01000101.xml

| 27.5.2016 | EN | Official Journal of the European Union | C 189/1 |
| --- | --- | --- | --- |

27.5.2016

EN

Official Journal of the European Union

C 189/1

---

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

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

1

(2016/C 189/01)

—   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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 4.4.2016 | Rasagiline Mylan | rasagiline | Mylan S.A.S
  117 allée des Parcs, F-69800 Saint Priest, France | EU/1/16/1090 | Tablet | N04BD02 | 6.4.2016 |
| 8.4.2016 | Palonosetron Hospira | palonosetron | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/16/1100 | Solution for injection | A04AA05 | 12.4.2016 |
| 21.4.2016 | Descovy | emtricitabine/tenofovir alafenamide | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1099 | Film-coated tablet | J05AR17 | 25.4.2016 |
| 25.4.2016 | Lonsurf | trifluridine/tipiracil | Les Laboratoires Servier
  50 rue Carnot, F-92284 Suresnes Cedex, France | EU/1/16/1096 | Film-coated tablet | L01BC | 27.4.2016 |
| 25.4.2016 | Taltz | ixekizumab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | Solution for injection | L04AC13 | 28.4.2016 |

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

4.4.2016

Rasagiline Mylan

rasagiline

Mylan S.A.S

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

EU/1/16/1090

Tablet

N04BD02

6.4.2016

8.4.2016

Palonosetron Hospira

palonosetron

Hospira UK Limited

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

EU/1/16/1100

Solution for injection

A04AA05

12.4.2016

21.4.2016

Descovy

emtricitabine/tenofovir alafenamide

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1099

Film-coated tablet

J05AR17

25.4.2016

25.4.2016

Lonsurf

trifluridine/tipiracil

Les Laboratoires Servier

50 rue Carnot, F-92284 Suresnes Cedex, France

EU/1/16/1096

Film-coated tablet

L01BC

27.4.2016

25.4.2016

Taltz

ixekizumab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

Solution for injection

L04AC13

28.4.2016

—   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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.4.2016 | Gardasil 9 | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 6.4.2016 |
| 4.4.2016 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 6.4.2016 |
| 4.4.2016 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 6.4.2016 |
| 4.4.2016 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 6.4.2016 |
| 4.4.2016 | Telzir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/282 | 6.4.2016 |
| 4.4.2016 | Xgeva | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/11/703 | 6.4.2016 |
| 7.4.2016 | Dafiro HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/574 | 11.4.2016 |
| 7.4.2016 | Imprida | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/373 | 11.4.2016 |
| 7.4.2016 | Ziagen | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/99/112 | 11.4.2016 |
| 8.4.2016 | Entacapone Orion | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/11/708 | 12.4.2016 |
| 8.4.2016 | INCRELEX | Ipsen Pharma
  65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France | EU/1/07/402 | 12.4.2016 |
| 8.4.2016 | Zyprexa | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/96/022 | 12.4.2016 |
| 13.4.2016 | Cholib | BGP Products Ltd
  Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom | EU/1/13/866 | 15.4.2016 |
| 13.4.2016 | Ibandronic acid Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/11/685 | 15.4.2016 |
| 13.4.2016 | Ixiaro | Valneva Austria GmbH
  Campus Vienna Biocenter 3, A-1030 Wien, Österreich | EU/1/08/501 | 15.4.2016 |
| 13.4.2016 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 15.4.2016 |
| 13.4.2016 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland | EU/1/13/824 | 15.4.2016 |
| 13.4.2016 | Paliperidone Janssen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/971 | 15.4.2016 |
| 13.4.2016 | Ryzodeg | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/806 | 15.4.2016 |
| 13.4.2016 | Tamiflu | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/02/222 | 15.4.2016 |
| 13.4.2016 | Tresiba | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/12/807 | 15.4.2016 |
| 13.4.2016 | Vectibix | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423 | 15.4.2016 |
| 13.4.2016 | Zypadhera | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/479 | 15.4.2016 |
| 18.4.2016 | Exjade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/06/356 | 20.4.2016 |
| 18.4.2016 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 20.4.2016 |
| 21.4.2016 | Abilify | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/04/276 | 25.4.2016 |
| 21.4.2016 | Bonviva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/03/265 | 25.4.2016 |
| 21.4.2016 | Dasselta | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/11/739 | 25.4.2016 |
| 21.4.2016 | Desloratadine ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/746 | 25.4.2016 |
| 21.4.2016 | Exviera | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/983 | 25.4.2016 |
| 21.4.2016 | Helicobacter Test INFAI | INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH
  Universitätsstraße 142, D-44799 Bochum, Deutschland | EU/1/97/045 | 25.4.2016 |
| 21.4.2016 | Nplate | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/08/497 | 25.4.2016 |
| 21.4.2016 | Temozolomide SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland | EU/1/11/697 | 25.4.2016 |
| 21.4.2016 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 25.4.2016 |
| 21.4.2016 | Zoely | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/690 | 25.4.2016 |
| 25.4.2016 | Bondronat | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/96/012 | 27.4.2016 |
| 25.4.2016 | Competact | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/06/354 | 27.4.2016 |
| 25.4.2016 | Cubicin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/05/328 | 27.4.2016 |
| 25.4.2016 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 27.4.2016 |
| 25.4.2016 | Jardiance | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/930 | 27.4.2016 |
| 25.4.2016 | Picato | Leo Pharma A/S
  Industriparken 55, DK-2750 Ballerup, Danmark | EU/1/12/796 | 27.4.2016 |
| 25.4.2016 | Trizivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/00/156 | 27.4.2016 |
| 25.4.2016 | Tysabri | Biogen Idec Limited
  Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom | EU/1/06/346 | 27.4.2016 |
| 28.4.2016 | ABILIFY MAINTENA | Otsuka Pharmaceutical Europe Ltd
  Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom | EU/1/13/882 | 3.5.2016 |
| 28.4.2016 | Forxiga | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/795 | 2.5.2016 |
| 28.4.2016 | Levetiracetam ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/11/702 | 2.5.2016 |
| 28.4.2016 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 2.5.2016 |
| 28.4.2016 | Viekirax | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/982 | 3.5.2016 |
| 28.4.2016 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 2.5.2016 |
| 28.4.2016 | Xigduo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/900 | 2.5.2016 |
| 28.4.2016 | ZALTRAP | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/12/814 | 2.5.2016 |

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

4.4.2016

Gardasil 9

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

6.4.2016

4.4.2016

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

6.4.2016

4.4.2016

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

6.4.2016

4.4.2016

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

6.4.2016

4.4.2016

Telzir

ViiV Healthcare UK Limited

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

EU/1/04/282

6.4.2016

4.4.2016

Xgeva

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/11/703

6.4.2016

7.4.2016

Dafiro HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/574

11.4.2016

7.4.2016

Imprida

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/373

11.4.2016

7.4.2016

Ziagen

ViiV Healthcare UK Limited

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

EU/1/99/112

11.4.2016

8.4.2016

Entacapone Orion

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/11/708

12.4.2016

8.4.2016

INCRELEX

Ipsen Pharma

65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France

EU/1/07/402

12.4.2016

8.4.2016

Zyprexa

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/96/022

12.4.2016

13.4.2016

Cholib

BGP Products Ltd

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

EU/1/13/866

15.4.2016

13.4.2016

Ibandronic acid Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/11/685

15.4.2016

13.4.2016

Ixiaro

Valneva Austria GmbH

Campus Vienna Biocenter 3, A-1030 Wien, Österreich

EU/1/08/501

15.4.2016

13.4.2016

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

15.4.2016

13.4.2016

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Ísland

EU/1/13/824

15.4.2016

13.4.2016

Paliperidone Janssen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/971

15.4.2016

13.4.2016

Ryzodeg

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/806

15.4.2016

13.4.2016

Tamiflu

Roche Registration Limited

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

EU/1/02/222

15.4.2016

13.4.2016

Tresiba

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/12/807

15.4.2016

13.4.2016

Vectibix

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423

15.4.2016

13.4.2016

Zypadhera

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/479

15.4.2016

18.4.2016

Exjade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/06/356

20.4.2016

18.4.2016

Tysabri

Biogen Idec Limited

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

EU/1/06/346

20.4.2016

21.4.2016

Abilify

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/04/276

25.4.2016

21.4.2016

Bonviva

Roche Registration Limited

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

EU/1/03/265

25.4.2016

21.4.2016

Dasselta

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/11/739

25.4.2016

21.4.2016

Desloratadine ratiopharm

ratiopharm GmbH

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

EU/1/11/746

25.4.2016

21.4.2016

Exviera

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/983

25.4.2016

21.4.2016

Helicobacter Test INFAI

INFAI, Institut für biomedizinische Analytik und NMR-Imaging GmbH

Universitätsstraße 142, D-44799 Bochum, Deutschland

EU/1/97/045

25.4.2016

21.4.2016

Nplate

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/08/497

25.4.2016

21.4.2016

Temozolomide SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland

EU/1/11/697

25.4.2016

21.4.2016

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

25.4.2016

21.4.2016

Zoely

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/690

25.4.2016

25.4.2016

Bondronat

Roche Registration Limited

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

EU/1/96/012

27.4.2016

25.4.2016

Competact

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/06/354

27.4.2016

25.4.2016

Cubicin

Merck Sharp & Dohme Limited

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

EU/1/05/328

27.4.2016

25.4.2016

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

27.4.2016

25.4.2016

Jardiance

Boehringer Ingelheim International GmbH

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

EU/1/14/930

27.4.2016

25.4.2016

Picato

Leo Pharma A/S

Industriparken 55, DK-2750 Ballerup, Danmark

EU/1/12/796

27.4.2016

25.4.2016

Trizivir

ViiV Healthcare UK Limited

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

EU/1/00/156

27.4.2016

25.4.2016

Tysabri

Biogen Idec Limited

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

EU/1/06/346

27.4.2016

28.4.2016

ABILIFY MAINTENA

Otsuka Pharmaceutical Europe Ltd

Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom

EU/1/13/882

3.5.2016

28.4.2016

Forxiga

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/795

2.5.2016

28.4.2016

Levetiracetam ratiopharm

ratiopharm GmbH

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

EU/1/11/702

2.5.2016

28.4.2016

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

2.5.2016

28.4.2016

Viekirax

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/982

3.5.2016

28.4.2016

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

2.5.2016

28.4.2016

Xigduo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/900

2.5.2016

28.4.2016

ZALTRAP

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/12/814

2.5.2016

—   Issuing of a marketing authorisation (Article 38 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 authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 18.4.2016 | Evalon | Coccidiosis vaccine live for chickens | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/16/194 | Suspension and solvent for oral spray | QI01AN01 | 20.4.2016 |
| 20.4.2016 | LETIFEND | Recombinant Protein Q from L. infantum MON-1 | Laboratorios LETI, S.L.unipersonal
  C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España | EU/2/16/195 | Lyophilisate and solvent for solution for injection | QI07A | 22.4.2016 |

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

18.4.2016

Evalon

Coccidiosis vaccine live for chickens

Laboratorios Hipra, S.A.

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

EU/2/16/194

Suspension and solvent for oral spray

QI01AN01

20.4.2016

20.4.2016

LETIFEND

Recombinant Protein Q from L. infantum MON-1

Laboratorios LETI, S.L.unipersonal

C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España

EU/2/16/195

Lyophilisate and solvent for solution for injection

QI07A

22.4.2016

—   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 authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 4.4.2016 | Meloxidolor | Le Vet Beheer B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/13/148 | 6.4.2016 |
| 12.4.2016 | BTVPUR | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/10/113 | 14.4.2016 |
| 12.4.2016 | Poulvac E. coli | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/12/140 | 14.4.2016 |
| 18.4.2016 | CERTIFECT | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/11/125 | 20.4.2016 |
| 18.4.2016 | Clomicalm | Elanco Europe Ltd
  Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/98/007 | 20.4.2016 |
| 18.4.2016 | ECOPORC SHIGA | IDT Biologika GmbH
  Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland | EU/2/13/149 | 20.4.2016 |
| 18.4.2016 | Pexion | Boehringer Ingelheim Vetmedica GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/2/12/147 | 20.4.2016 |
| 18.4.2016 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 20.4.2016 |
| 18.4.2016 | Zulvac 1 Bovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/130 | 20.4.2016 |
| 18.4.2016 | Zulvac 1 Ovis | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/11/131 | 20.4.2016 |
| 20.4.2016 | Aftovaxpur Doe | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/153 | 22.4.2016 |
| 20.4.2016 | Oncept IL-2 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/13/150 | 22.4.2016 |
| 27.4.2016 | Draxxin | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/03/041 | 29.4.2016 |
| 27.4.2016 | Naxcel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/05/053 | 29.4.2016 |

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

4.4.2016

Meloxidolor

Le Vet Beheer B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/13/148

6.4.2016

12.4.2016

BTVPUR

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/10/113

14.4.2016

12.4.2016

Poulvac E. coli

Zoetis Belgium S.A.

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

EU/2/12/140

14.4.2016

18.4.2016

CERTIFECT

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/11/125

20.4.2016

18.4.2016

Clomicalm

Elanco Europe Ltd

Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom

EU/2/98/007

20.4.2016

18.4.2016

ECOPORC SHIGA

IDT Biologika GmbH

Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland

EU/2/13/149

20.4.2016

18.4.2016

Pexion

Boehringer Ingelheim Vetmedica GmbH

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

EU/2/12/147

20.4.2016

18.4.2016

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

20.4.2016

18.4.2016

Zulvac 1 Bovis

Zoetis Belgium S.A.

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

EU/2/11/130

20.4.2016

18.4.2016

Zulvac 1 Ovis

Zoetis Belgium S.A.

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

EU/2/11/131

20.4.2016

20.4.2016

Aftovaxpur Doe

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/153

22.4.2016

20.4.2016

Oncept IL-2

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/13/150

22.4.2016

27.4.2016

Draxxin

Zoetis Belgium S.A.

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

EU/2/03/041

29.4.2016

27.4.2016

Naxcel

Zoetis Belgium S.A.

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

EU/2/05/053

29.4.2016

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

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

1

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