# C_2017102EN.01000101.xml

| 31.3.2017 | EN | Official Journal of the European Union | C 102/1 |
| --- | --- | --- | --- |

31.3.2017

EN

Official Journal of the European Union

C 102/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2017 to 28 February 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 102/01)

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

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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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 13.2.2017 | LIFMIOR | etanercept | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/16/1165 | Powder and solvent for solution for injection | L04AB01 | 15.2.2017 |
| 13.2.2017 | Olumiant | baricitinib | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/16/1170 | Film-coated tablet | L04AA37 | 15.2.2017 |
| 13.2.2017 | Vihuma | simoctocog alfa | Octapharma AB
  Lars Forssells gata 23, 112 75 Stockholm, Sverige | EU/1/16/1168 | Powder and solvent for solution for injection | B02BD02 | 15.2.2017 |
| 16.2.2017 | Alecensa | alectinib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | Capsule, hard | L01XE36 | 20.2.2017 |
| 17.2.2017 | Truxima | rituximab | Celltrion Healthcare Hungary Kft.
  1051 Budapest Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország | EU/1/16/1167 | Concentrate for solution for infusion | L01XC02 | 22.2.2017 |
| 27.2.2017 | Pregabalin Zentiva k.s | pregabalin | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/16/1166 | Capsule, hard | N03AX16 | 1.3.2017 |

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

13.2.2017

LIFMIOR

etanercept

Pfizer Limited

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

EU/1/16/1165

Powder and solvent for solution for injection

L04AB01

15.2.2017

13.2.2017

Olumiant

baricitinib

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/16/1170

Film-coated tablet

L04AA37

15.2.2017

13.2.2017

Vihuma

simoctocog alfa

Octapharma AB

Lars Forssells gata 23, 112 75 Stockholm, Sverige

EU/1/16/1168

Powder and solvent for solution for injection

B02BD02

15.2.2017

16.2.2017

Alecensa

alectinib

Roche Registration Limited

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

EU/1/16/1169

Capsule, hard

L01XE36

20.2.2017

17.2.2017

Truxima

rituximab

Celltrion Healthcare Hungary Kft.

1051 Budapest Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország

EU/1/16/1167

Concentrate for solution for infusion

L01XC02

22.2.2017

27.2.2017

Pregabalin Zentiva k.s

pregabalin

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/16/1166

Capsule, hard

N03AX16

1.3.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 6.2.2017 | Alimta | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/04/290 | 8.2.2017 |
| 6.2.2017 | Amyvid | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/12/805 | 8.2.2017 |
| 6.2.2017 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 8.2.2017 |
| 6.2.2017 | Gardasil | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 8.2.2017 |
| 6.2.2017 | Imvanex | Bavarian Nordic A/S
  Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark | EU/1/13/855 | 8.2.2017 |
| 6.2.2017 | Scintimun | CIS bio international
  Boîte postale 32, F-91192 Gif-sur-Yvette, France | EU/1/09/602 | 8.2.2017 |
| 6.2.2017 | Silgard | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/06/358 | 8.2.2017 |
| 6.2.2017 | Stribild | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/830 | 8.2.2017 |
| 6.2.2017 | Tolucombi | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/13/821 | 9.2.2017 |
| 6.2.2017 | Victrelis | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/11/704 | 8.2.2017 |
| 8.2.2017 | Optruma | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/98/074 | 10.2.2017 |
| 13.2.2017 | Aripiprazole Zentiva | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | 15.2.2017 |
| 13.2.2017 | Senshio | Shionogi Limited
  33 Kingsway, London WC2B 6UF, United Kingdom | EU/1/14/978 | 15.2.2017 |
| 13.2.2017 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 15.2.2017 |
| 16.2.2017 | Aripiprazole Sandoz | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1029 | 20.2.2017 |
| 16.2.2017 | Armisarte | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/15/1063 | 20.2.2017 |
| 16.2.2017 | Brimica Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/963 | 20.2.2017 |
| 16.2.2017 | Docetaxel Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/611 | 20.2.2017 |
| 16.2.2017 | Duaklir Genuair | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/14/964 | 20.2.2017 |
| 16.2.2017 | Enyglid | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/580 | 20.2.2017 |
| 16.2.2017 | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | 20.2.2017 |
| 16.2.2017 | Farydak | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1023 | 20.2.2017 |
| 16.2.2017 | Forsteo | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/03/247 | 20.2.2017 |
| 16.2.2017 | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | 20.2.2017 |
| 16.2.2017 | INOmax | Linde Healthcare AB
  SE-181 81 Lidingö, Sverige | EU/1/01/194 | 22.2.2017 |
| 16.2.2017 | Irbesartan/Hydrochlorothiazide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/583 | 20.2.2017 |
| 16.2.2017 | Kadcyla | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/885 | 20.2.2017 |
| 16.2.2017 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 20.2.2017 |
| 16.2.2017 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 20.2.2017 |
| 16.2.2017 | Mirapexin | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/051 | 20.2.2017 |
| 16.2.2017 | Neupro | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/05/331 | 20.2.2017 |
| 16.2.2017 | Nimenrix | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/12/767 | 20.2.2017 |
| 16.2.2017 | Nonafact | Sanquin Plasma Products B.V.
  Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland | EU/1/01/186 | 20.2.2017 |
| 16.2.2017 | Nucala | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/15/1043 | 20.2.2017 |
| 16.2.2017 | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | EU/1/07/398 | 20.2.2017 |
| 16.2.2017 | Portrazza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1084 | 20.2.2017 |
| 16.2.2017 | Quinsair | Horizon Pharma Europe B.V.
  Naritaweg 165, NL-1043 BW Amsterdam, Nederland | EU/1/14/973 | 20.2.2017 |
| 16.2.2017 | Ravicti | Horizon Pharma Ireland Limited
  Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland | EU/1/15/1062 | 20.2.2017 |
| 16.2.2017 | Repaglinide Krka | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/579 | 20.2.2017 |
| 16.2.2017 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 20.2.2017 |
| 16.2.2017 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 20.2.2017 |
| 16.2.2017 | Rivastigmine Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/11/693 | 20.2.2017 |
| 16.2.2017 | Sifrol | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/97/050 | 20.2.2017 |
| 16.2.2017 | Stocrin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111 | 20.2.2017 |
| 16.2.2017 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 20.2.2017 |
| 16.2.2017 | Viread | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/01/200 | 20.2.2017 |
| 16.2.2017 | Zyprexa Velotab | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/99/125 | 20.2.2017 |
| 17.2.2017 | Caprelsa | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/11/749 | 21.2.2017 |
| 17.2.2017 | Cyramza | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/957 | 21.2.2017 |
| 17.2.2017 | Emend | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/03/262 | 21.2.2017 |
| 17.2.2017 | IMBRUVICA | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/945 | 21.2.2017 |
| 17.2.2017 | Pioglitazone Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/757 | 21.2.2017 |
| 17.2.2017 | Pioglitazone Teva Pharma | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/12/758 | 21.2.2017 |
| 17.2.2017 | Repatha | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/15/1016 | 21.2.2017 |
| 23.2.2017 | Dacogen | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/12/792 | 27.2.2017 |
| 23.2.2017 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 27.2.2017 |
| 23.2.2017 | Docetaxel Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/12/769 | 27.2.2017 |
| 23.2.2017 | Docetaxel Kabi | Fresenius Kabi Oncology Plc.
  Lion Court, Farnham Road, Bordon, Hampshire GU35 0NF, United Kingdom | EU/1/12/770 | 27.2.2017 |
| 23.2.2017 | Exviera | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/983 | 27.2.2017 |
| 23.2.2017 | Harvoni | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/14/958 | 27.2.2017 |
| 23.2.2017 | Ilaris | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/09/564 | 27.2.2017 |
| 23.2.2017 | Ketoconazole HRA | Laboratoire HRA Pharma
  15 rue Béranger, F-75003 Paris, France | EU/1/14/965 | 27.2.2017 |
| 23.2.2017 | Lamivudine Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/566 | 27.2.2017 |
| 23.2.2017 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | 27.2.2017 |
| 23.2.2017 | Revlimid | Celgene Europe Limited
  1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom | EU/1/07/391 | 27.2.2017 |
| 23.2.2017 | Sovaldi | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/13/894 | 27.2.2017 |
| 23.2.2017 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 27.2.2017 |
| 23.2.2017 | Vargatef | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/14/954 | 27.2.2017 |
| 23.2.2017 | Viekirax | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/14/982 | 27.2.2017 |
| 23.2.2017 | Zinforo | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/12/785 | 27.2.2017 |
| 27.2.2017 | Adcirca | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/08/476 | 1.3.2017 |
| 27.2.2017 | Kisplyx | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom | EU/1/16/1128 | 1.3.2017 |
| 27.2.2017 | Vectibix | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/07/423 | 1.3.2017 |

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

6.2.2017

Alimta

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/04/290

8.2.2017

6.2.2017

Amyvid

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/12/805

8.2.2017

6.2.2017

APTIVUS

Boehringer Ingelheim International GmbH

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

EU/1/05/315

8.2.2017

6.2.2017

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

8.2.2017

6.2.2017

Imvanex

Bavarian Nordic A/S

Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark

EU/1/13/855

8.2.2017

6.2.2017

Scintimun

CIS bio international

Boîte postale 32, F-91192 Gif-sur-Yvette, France

EU/1/09/602

8.2.2017

6.2.2017

Silgard

Merck Sharp & Dohme Limited

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

EU/1/06/358

8.2.2017

6.2.2017

Stribild

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/830

8.2.2017

6.2.2017

Tolucombi

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/13/821

9.2.2017

6.2.2017

Victrelis

Merck Sharp & Dohme Limited

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

EU/1/11/704

8.2.2017

8.2.2017

Optruma

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/98/074

10.2.2017

13.2.2017

Aripiprazole Zentiva

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

15.2.2017

13.2.2017

Senshio

Shionogi Limited

33 Kingsway, London WC2B 6UF, United Kingdom

EU/1/14/978

15.2.2017

13.2.2017

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

15.2.2017

16.2.2017

Aripiprazole Sandoz

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1029

20.2.2017

16.2.2017

Armisarte

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/15/1063

20.2.2017

16.2.2017

Brimica Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/963

20.2.2017

16.2.2017

Docetaxel Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/611

20.2.2017

16.2.2017

Duaklir Genuair

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/14/964

20.2.2017

16.2.2017

Enyglid

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/580

20.2.2017

16.2.2017

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

20.2.2017

16.2.2017

Farydak

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1023

20.2.2017

16.2.2017

Forsteo

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/03/247

20.2.2017

16.2.2017

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

20.2.2017

16.2.2017

INOmax

Linde Healthcare AB

SE-181 81 Lidingö, Sverige

EU/1/01/194

22.2.2017

16.2.2017

Irbesartan/Hydrochlorothiazide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/583

20.2.2017

16.2.2017

Kadcyla

Roche Registration Limited

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

EU/1/13/885

20.2.2017

16.2.2017

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

20.2.2017

16.2.2017

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

20.2.2017

16.2.2017

Mirapexin

Boehringer Ingelheim International GmbH

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

EU/1/97/051

20.2.2017

16.2.2017

Neupro

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/05/331

20.2.2017

16.2.2017

Nimenrix

Pfizer Limited

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

EU/1/12/767

20.2.2017

16.2.2017

Nonafact

Sanquin Plasma Products B.V.

Plesmanlaan 125, NL-1066 CX Amsterdam, Nederland

EU/1/01/186

20.2.2017

16.2.2017

Nucala

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/15/1043

20.2.2017

16.2.2017

Optimark

Mallinckrodt Deutschland GmbH

Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland

EU/1/07/398

20.2.2017

16.2.2017

Portrazza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1084

20.2.2017

16.2.2017

Quinsair

Horizon Pharma Europe B.V.

Naritaweg 165, NL-1043 BW Amsterdam, Nederland

EU/1/14/973

20.2.2017

16.2.2017

Ravicti

Horizon Pharma Ireland Limited

Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland

EU/1/15/1062

20.2.2017

16.2.2017

Repaglinide Krka

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/579

20.2.2017

16.2.2017

Revlimid

Celgene Europe Limited

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

EU/1/07/391

20.2.2017

16.2.2017

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

20.2.2017

16.2.2017

Rivastigmine Actavis

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/11/693

20.2.2017

16.2.2017

Sifrol

Boehringer Ingelheim International GmbH

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

EU/1/97/050

20.2.2017

16.2.2017

Stocrin

Merck Sharp & Dohme Limited

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

EU/1/99/111

20.2.2017

16.2.2017

Twynsta

Boehringer Ingelheim International GmbH

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

EU/1/10/648

20.2.2017

16.2.2017

Viread

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/01/200

20.2.2017

16.2.2017

Zyprexa Velotab

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/99/125

20.2.2017

17.2.2017

Caprelsa

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/11/749

21.2.2017

17.2.2017

Cyramza

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/957

21.2.2017

17.2.2017

Emend

Merck Sharp & Dohme Limited

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

EU/1/03/262

21.2.2017

17.2.2017

IMBRUVICA

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/945

21.2.2017

17.2.2017

Pioglitazone Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/757

21.2.2017

17.2.2017

Pioglitazone Teva Pharma

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/12/758

21.2.2017

17.2.2017

Repatha

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/15/1016

21.2.2017

23.2.2017

Dacogen

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/12/792

27.2.2017

23.2.2017

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

EU/1/14/939

27.2.2017

23.2.2017

Docetaxel Accord

Accord Healthcare Limited

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

EU/1/12/769

27.2.2017

23.2.2017

Docetaxel Kabi

Fresenius Kabi Oncology Plc.

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

EU/1/12/770

27.2.2017

23.2.2017

Exviera

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/983

27.2.2017

23.2.2017

Harvoni

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/14/958

27.2.2017

23.2.2017

Ilaris

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/09/564

27.2.2017

23.2.2017

Ketoconazole HRA

Laboratoire HRA Pharma

15 rue Béranger, F-75003 Paris, France

EU/1/14/965

27.2.2017

23.2.2017

Lamivudine Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/566

27.2.2017

23.2.2017

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

27.2.2017

23.2.2017

Revlimid

Celgene Europe Limited

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

EU/1/07/391

27.2.2017

23.2.2017

Sovaldi

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/13/894

27.2.2017

23.2.2017

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

27.2.2017

23.2.2017

Vargatef

Boehringer Ingelheim International GmbH

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

EU/1/14/954

27.2.2017

23.2.2017

Viekirax

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/14/982

27.2.2017

23.2.2017

Zinforo

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/12/785

27.2.2017

27.2.2017

Adcirca

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/08/476

1.3.2017

27.2.2017

Kisplyx

Eisai Europe Limited

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

EU/1/16/1128

1.3.2017

27.2.2017

Vectibix

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/07/423

1.3.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 2.2.2017 | VarroMed | oxalic acid dihydrate/formic acid | BeeVital GmbH
  Wiesenbergstrasse 19, 5164, Seeham, Österreich | EU/2/16/203 | Bee-hive dispersion | Pending | 6.2.2017 |
| 9.2.2017 | Stronghold Plus | selamectin/sarolaner | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/16/204 | Spot-on solution | QP54AA55 | 13.2.2017 |

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

2.2.2017

VarroMed

oxalic acid dihydrate/formic acid

BeeVital GmbH

Wiesenbergstrasse 19, 5164, Seeham, Österreich

EU/2/16/203

Bee-hive dispersion

Pending

6.2.2017

9.2.2017

Stronghold Plus

selamectin/sarolaner

Zoetis Belgium S.A.

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

EU/2/16/204

Spot-on solution

QP54AA55

13.2.2017

| — | 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 (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 |
| --- | --- | --- | --- | --- |
| 9.2.2017 | EQUIOXX | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/08/083 | 13.2.2017 |
| 10.2.2017 | Vectormune ND | CEVA-Phylaxia Co. Ltd
  Budapest, Szállás u. 5, 1107 MAGYARORSZÁG | EU/2/15/188 | 14.2.2017 |
| 17.2.2017 | ERYSENG PARVO | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/14/167 | 21.2.2017 |
| 17.2.2017 | Trifexis | Eli Lilly and Company Ltd, Elanco Animal Health
  Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom | EU/2/13/155 | 21.2.2017 |
| 17.2.2017 | Vectra 3D | CEVA SANTE ANIMALE
  10 avenue de la Ballastière, F-33500 Libourne, France | EU/2/13/156 | 21.2.2017 |
| 27.2.2017 | Equip WNV | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/08/086 | 1.3.2017 |

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

9.2.2017

EQUIOXX

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/08/083

13.2.2017

10.2.2017

Vectormune ND

CEVA-Phylaxia Co. Ltd

Budapest, Szállás u. 5, 1107 MAGYARORSZÁG

EU/2/15/188

14.2.2017

17.2.2017

ERYSENG PARVO

Laboratorios Hipra, S.A.

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

EU/2/14/167

21.2.2017

17.2.2017

Trifexis

Eli Lilly and Company Ltd, Elanco Animal Health

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

EU/2/13/155

21.2.2017

17.2.2017

Vectra 3D

CEVA SANTE ANIMALE

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

EU/2/13/156

21.2.2017

27.2.2017

Equip WNV

Zoetis Belgium S.A.

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

EU/2/08/086

1.3.2017

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

---

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

1

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