# C_2017135EN.01000101.xml

| 28.4.2017 | EN | Official Journal of the European Union | C 135/1 |
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28.4.2017

EN

Official Journal of the European Union

C 135/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017

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

1

(2017/C 135/01)

| — | 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 (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3.3.2017 | Ledaga | chlormethine | Actelion Registration Ltd
  Chiswick Tower, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/16/1171 | Gel | L01AA05 | 7.3.2017 |
| 20.3.2017 | Rolufta | umeclidinium | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/17/1174 | Inhalation powder, pre-dispensed | R03BB07 | 22.3.2017 |
| 22.3.2017 | AMGEVITA | adalimumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/16/1164 | Solution for injection | L04AB04 | 24.3.2017 |
| 22.3.2017 | Daptomycin Hospira | daptomycin | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/17/1175 | Powder for solution for injection or infusion | J01XX09 | 24.3.2017 |
| 22.3.2017 | SOLYMBIC | adalimumab | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/16/1163 | Solution for injection | L04AB04 | 24.3.2017 |
| 22.3.2017 | Tadalafil Lilly | tadalafil | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/17/1177 | Film-coated tablet | G04BE08 | 24.3.2017 |
| 22.3.2017 | Xeljanz | Tofacitinib | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/17/1178 | Film-coated tablet | L04AA29 | 24.3.2017 |
| 22.3.2017 | Yargesa | miglustat | JensonR+ Limited
  Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom | EU/1/17/1176 | Capsule, hard | A16AX06 | 24.3.2017 |
| 29.3.2017 | Jylamvo | methotrexate | Therakind Ltd
  314 Regents Park Road, London N3 2JX, United Kingdom | EU/1/17/1172 | Oral solution | L01BA01 | 31.3.2017 |

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

3.3.2017

Ledaga

chlormethine

Actelion Registration Ltd

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

EU/1/16/1171

Gel

L01AA05

7.3.2017

20.3.2017

Rolufta

umeclidinium

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/17/1174

Inhalation powder, pre-dispensed

R03BB07

22.3.2017

22.3.2017

AMGEVITA

adalimumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/16/1164

Solution for injection

L04AB04

24.3.2017

22.3.2017

Daptomycin Hospira

daptomycin

Hospira UK Limited

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

EU/1/17/1175

Powder for solution for injection or infusion

J01XX09

24.3.2017

22.3.2017

SOLYMBIC

adalimumab

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/16/1163

Solution for injection

L04AB04

24.3.2017

22.3.2017

Tadalafil Lilly

tadalafil

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/17/1177

Film-coated tablet

G04BE08

24.3.2017

22.3.2017

Xeljanz

Tofacitinib

Pfizer Limited

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

EU/1/17/1178

Film-coated tablet

L04AA29

24.3.2017

22.3.2017

Yargesa

miglustat

JensonR+ Limited

Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom

EU/1/17/1176

Capsule, hard

A16AX06

24.3.2017

29.3.2017

Jylamvo

methotrexate

Therakind Ltd

314 Regents Park Road, London N3 2JX, United Kingdom

EU/1/17/1172

Oral solution

L01BA01

31.3.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 3.3.2017 | Baraclude | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/06/343 | 7.3.2017 |
| 3.3.2017 | Combivir | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/98/058 | 7.3.2017 |
| 3.3.2017 | Deltyba | Otsuka Novel Products GmbH
  Erika-Mann-Straße 21, D-80636 München, Deutschland | EU/1/13/875 | 7.3.2017 |
| 3.3.2017 | Gardasil 9 | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | 7.3.2017 |
| 3.3.2017 | Synjardy | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/15/1003 | 7.3.2017 |
| 9.3.2017 | Ziagen | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/99/112 | 13.3.2017 |
| 17.3.2017 | Fortacin | Plethora Solutions Limited
  Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom | EU/1/13/881 | 21.3.2017 |
| 17.3.2017 | Tybost | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/872 | 21.3.2017 |
| 20.3.2017 | Benlysta | Glaxo Group Ltd
  980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom | EU/1/11/700 | 22.3.2017 |
| 20.3.2017 | Entacapone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/665 | 22.3.2017 |
| 20.3.2017 | Repso | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/11/674 | 22.3.2017 |
| 20.3.2017 | Telmisartan Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/610 | 22.3.2017 |
| 20.3.2017 | Unituxin | United Therapeutics Europe Ltd
  Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom | EU/1/15/1022 | 22.3.2017 |
| 20.3.2017 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  SE-112 76 Stockholm, Sverige | EU/1/11/671 | 22.3.2017 |
| 22.3.2017 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 23.3.2017 |
| 22.3.2017 | Betaferon | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/95/003 | 24.3.2017 |
| 22.3.2017 | Briviact | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/15/1073 | 24.3.2017 |
| 22.3.2017 | Cosentyx | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/980 | 24.3.2017 |
| 22.3.2017 | Fluenz Tetra | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/13/887 | 24.3.2017 |
| 22.3.2017 | Ilaris | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/564 | 24.3.2017 |
| 22.3.2017 | Jentadueto | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/12/780 | 24.3.2017 |
| 22.3.2017 | Latuda | Sunovion Pharmaceuticals Europe Ltd
  First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom | EU/1/14/913 | 24.3.2017 |
| 22.3.2017 | Pixuvri | CTI Life Sciences Ltd
  Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom | EU/1/12/764 | 24.3.2017 |
| 22.3.2017 | TAGRISSO | AstraZeneca AB
  Gärtunavägen, SE-151 85 Södertälje, Sverige | EU/1/16/1086 | 24.3.2017 |
| 22.3.2017 | Zyclara | Meda AB
  Pipers väg 2A, SE-170 73 Solna, Sverige | EU/1/12/783 | 24.3.2017 |
| 24.3.2017 | Bosulif | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/13/818 | 28.3.2017 |
| 24.3.2017 | Caelyx | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/96/011 | 28.3.2017 |
| 24.3.2017 | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | 28.3.2017 |
| 24.3.2017 | Humira | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/03/256 | 28.3.2017 |
| 24.3.2017 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 28.3.2017 |
| 24.3.2017 | Nemdatine | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/824 | 28.3.2017 |
| 24.3.2017 | Nevirapine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/598 | 28.3.2017 |
| 24.3.2017 | NULOJIX | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/694 | 28.3.2017 |
| 24.3.2017 | Odefsey | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | 28.3.2017 |
| 24.3.2017 | Opdivo | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | 28.3.2017 |
| 24.3.2017 | Pandemic influenza vaccine H5N1 BAXTER | Nanotherapeutics UK Limited
  10 Chiswell Street, London, EC1Y 4UQ, United Kingdom | EU/1/09/571 | 28.3.2017 |
| 24.3.2017 | Truvada | Gilead Sciences International Ltd
  Cambridge, CB21 6GT, United Kingdom | EU/1/04/305 | 28.3.2017 |
| 24.3.2017 | Vimpat | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/08/470 | 28.3.2017 |
| 27.3.2017 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 29.3.2017 |
| 29.3.2017 | Clopidogrel/Acetylsalicylic acid Zentiva | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/10/623 | 31.3.2017 |
| 29.3.2017 | Descovy | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1099 | 31.3.2017 |
| 29.3.2017 | EVARREST | Omrix Biopharmaceuticals N.V.
  Leonardo Da Vincilaan 15, B-1831 Diegem, België | EU/1/13/868 | 31.3.2017 |
| 29.3.2017 | Iressa | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/09/526 | 31.3.2017 |
| 29.3.2017 | Levitra | Bayer AG
  D-51368 Leverkusen, Deutschland | EU/1/03/248 | 31.3.2017 |
| 29.3.2017 | Plavix | Sanofi Clir SNC
  54 rue La Boétie, F-75008 Paris, France | EU/1/98/069 | 31.3.2017 |
| 29.3.2017 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 31.3.2017 |

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

3.3.2017

Baraclude

Bristol-Myers Squibb Pharma EEIG

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

EU/1/06/343

7.3.2017

3.3.2017

Combivir

ViiV Healthcare UK Limited

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

EU/1/98/058

7.3.2017

3.3.2017

Deltyba

Otsuka Novel Products GmbH

Erika-Mann-Straße 21, D-80636 München, Deutschland

EU/1/13/875

7.3.2017

3.3.2017

Gardasil 9

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

7.3.2017

3.3.2017

Synjardy

Boehringer Ingelheim International GmbH

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

EU/1/15/1003

7.3.2017

9.3.2017

Ziagen

ViiV Healthcare UK Limited

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

EU/1/99/112

13.3.2017

17.3.2017

Fortacin

Plethora Solutions Limited

Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom

EU/1/13/881

21.3.2017

17.3.2017

Tybost

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/872

21.3.2017

20.3.2017

Benlysta

Glaxo Group Ltd

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

EU/1/11/700

22.3.2017

20.3.2017

Entacapone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/665

22.3.2017

20.3.2017

Repso

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/11/674

22.3.2017

20.3.2017

Telmisartan Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/610

22.3.2017

20.3.2017

Unituxin

United Therapeutics Europe Ltd

Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom

EU/1/15/1022

22.3.2017

20.3.2017

Xiapex

Swedish Orphan Biovitrum AB (publ)

SE-112 76 Stockholm, Sverige

EU/1/11/671

22.3.2017

22.3.2017

BeneFIX

Pfizer Limited

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

EU/1/97/047

23.3.2017

22.3.2017

Betaferon

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/95/003

24.3.2017

22.3.2017

Briviact

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/15/1073

24.3.2017

22.3.2017

Cosentyx

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/980

24.3.2017

22.3.2017

Fluenz Tetra

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/13/887

24.3.2017

22.3.2017

Ilaris

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/564

24.3.2017

22.3.2017

Jentadueto

Boehringer Ingelheim International GmbH

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

EU/1/12/780

24.3.2017

22.3.2017

Latuda

Sunovion Pharmaceuticals Europe Ltd

First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom

EU/1/14/913

24.3.2017

22.3.2017

Pixuvri

CTI Life Sciences Ltd

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

EU/1/12/764

24.3.2017

22.3.2017

TAGRISSO

AstraZeneca AB

Gärtunavägen, SE-151 85 Södertälje, Sverige

EU/1/16/1086

24.3.2017

22.3.2017

Zyclara

Meda AB

Pipers väg 2A, SE-170 73 Solna, Sverige

EU/1/12/783

24.3.2017

24.3.2017

Bosulif

Pfizer Limited

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

EU/1/13/818

28.3.2017

24.3.2017

Caelyx

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/96/011

28.3.2017

24.3.2017

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

28.3.2017

24.3.2017

Humira

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/03/256

28.3.2017

24.3.2017

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

28.3.2017

24.3.2017

Nemdatine

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/824

28.3.2017

24.3.2017

Nevirapine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/598

28.3.2017

24.3.2017

NULOJIX

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/694

28.3.2017

24.3.2017

Odefsey

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

28.3.2017

24.3.2017

Opdivo

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

28.3.2017

24.3.2017

Pandemic influenza vaccine H5N1 BAXTER

Nanotherapeutics UK Limited

10 Chiswell Street, London, EC1Y 4UQ, United Kingdom

EU/1/09/571

28.3.2017

24.3.2017

Truvada

Gilead Sciences International Ltd

Cambridge, CB21 6GT, United Kingdom

EU/1/04/305

28.3.2017

24.3.2017

Vimpat

UCB Pharma S.A.

Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België

EU/1/08/470

28.3.2017

27.3.2017

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

29.3.2017

29.3.2017

Clopidogrel/Acetylsalicylic acid Zentiva

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/10/623

31.3.2017

29.3.2017

Descovy

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1099

31.3.2017

29.3.2017

EVARREST

Omrix Biopharmaceuticals N.V.

Leonardo Da Vincilaan 15, B-1831 Diegem, België

EU/1/13/868

31.3.2017

29.3.2017

Iressa

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/09/526

31.3.2017

29.3.2017

Levitra

Bayer AG

D-51368 Leverkusen, Deutschland

EU/1/03/248

31.3.2017

29.3.2017

Plavix

Sanofi Clir SNC

54 rue La Boétie, F-75008 Paris, France

EU/1/98/069

31.3.2017

29.3.2017

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

31.3.2017

| — | Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) |
| --- | --- |

—

Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

Withdrawal of a marketing authorisation

| 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 |
| --- | --- | --- | --- | --- |
| 20.3.2017 | Unituxin | United Therapeutics Europe Ltd
  Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom | EU/1/15/1022 | 22.3.2017 |

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

20.3.2017

Unituxin

United Therapeutics Europe Ltd

Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom

EU/1/15/1022

22.3.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 6.3.2017 | Rabigen SAG2 | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France | EU/2/00/021 | 8.3.2017 |
| 13.3.2017 | Nobivac L4 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/143 | 15.3.2017 |
| 29.3.2017 | Dexdomitor | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/2/02/033 | 31.3.2017 |
| 29.3.2017 | Porcilis ColiClos | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/12/141 | 31.3.2017 |

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

6.3.2017

Rabigen SAG2

VIRBAC S.A.

1ère Avenue — 2065 m — L.I.D., F-06516 Carros Cedex, France

EU/2/00/021

8.3.2017

13.3.2017

Nobivac L4

Intervet International B.V.

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

EU/2/12/143

15.3.2017

29.3.2017

Dexdomitor

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/2/02/033

31.3.2017

29.3.2017

Porcilis ColiClos

Intervet International B.V.

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

EU/2/12/141

31.3.2017

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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