# Official Journal C 30/26 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 30 |
| | |
| English edition | Information and Notices | Volume 6126 January 2018 |

ISSN 1977-091X

Official Journal

of the European Union

C 30

English edition

Information and Notices

Volume 6126 January 2018

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| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2018/C 30/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2018/C 30/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC) | 10 |

Notice No

Contents

page

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2018/C 30/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)

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

1

2018/C 30/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2017 to 31 December 2017(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC)

10

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

EN

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IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 26.1.2018 | EN | Official Journal of the European Union | C 30/1 |
| --- | --- | --- | --- |

26.1.2018

EN

Official Journal of the European Union

C 30/1

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

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

(2018/C 030/01)

—   Issuing of a marketing authorization (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 authorization | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 8.12.2017 | Tacforius | tacrolimus | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/17/1244 | Prolonged release capsule, hard | L04AD02 | 12.12.2017 |
| 18.12.2017 | Alecensa | alectinib | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | Capsule, hard | L01XE36 | 20.12.2017 |

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

8.12.2017

Tacforius

tacrolimus

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/17/1244

Prolonged release capsule, hard

L04AD02

12.12.2017

18.12.2017

Alecensa

alectinib

Roche Registration Limited

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

EU/1/16/1169

Capsule, hard

L01XE36

20.12.2017

—   Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): 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 |
| --- | --- | --- | --- | --- |
| 8.12.2017 | Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech | XBiotech Germany GmbH
  Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland | — | 12.12.2017 |
| 18.12.2017 | Masipro | AB Science
  3 avenue George V, 75008 Paris, France | — | 20.12.2017 |

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

8.12.2017

Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

XBiotech Germany GmbH

Lyoner Straße 14, 60528 Frankfurt am Main, Deutschland

—

12.12.2017

18.12.2017

Masipro

AB Science

3 avenue George V, 75008 Paris, France

—

20.12.2017

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 1.12.2017 | Alecensa | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/16/1169 | 5.12.2017 |
| 1.12.2017 | Hetlioz | Vanda Pharmaceuticals Limited
  25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom | EU/1/15/1008 | 5.12.2017 |
| 1.12.2017 | Jakavi | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/12/773 | 5.12.2017 |
| 1.12.2017 | OCALIVA | Intercept Pharma Ltd
  2 Pancras Square, London N1C 4AG, United Kingdom | EU/1/16/1139 | 5.12.2017 |
| 1.12.2017 | Thymanax | Servier (Ireland) Industries Limited
  Gorey Road, Arklow, Co. Wicklow, Ireland | EU/1/08/498 | 5.12.2017 |
| 8.12.2017 | Ceplene | Noventia Pharma Srl
  Via Carlo Pisacane 31, 47121 Forli, Italia | EU/1/08/477 | 12.12.2017 |
| 8.12.2017 | Dexdor | Orion Corporation
  Orionintie 1, 02200 Espoo, Suomi | EU/1/11/718 | 12.12.2017 |
| 8.12.2017 | Esbriet | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/11/667 | 13.12.2017 |
| 8.12.2017 | Esmya | Gedeon Richter Plc.
  Gyömrői út 19-21., 1103 Budapest, Magyarország | EU/1/12/750 | 12.12.2017 |
| 8.12.2017 | Genvoya | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/15/1061 | 12.12.2017 |
| 8.12.2017 | GILENYA | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/677 | 13.12.2017 |
| 8.12.2017 | Humira | AbbVie Ltd
  Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom | EU/1/03/256 | 12.12.2017 |
| 8.12.2017 | Januvia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/383 | 13.12.2017 |
| 8.12.2017 | JETREA | ThromboGenics NV
  Gaston Geenslaan 1, 3001 Leuven, België | EU/1/13/819 | 12.12.2017 |
| 8.12.2017 | KEYTRUDA | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/15/1024 | 13.12.2017 |
| 8.12.2017 | Leganto | UCB Manufacturing Ireland Ltd
  Shannon Industrial Estate, Co, Clare, Ireland | EU/1/11/695 | 12.12.2017 |
| 8.12.2017 | Lemtrada | Genzyme Therapeutics Ltd
  4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom | EU/1/13/869 | 13.12.2017 |
| 8.12.2017 | Moventig | Kyowa Kirin Limited
  Galabank Business Park, Galashiels, TD1 1QH, United Kingdom | EU/1/14/962 | 12.12.2017 |
| 8.12.2017 | Mysimba | Orexigen Therapeutics Ireland Limited
  2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland | EU/1/14/988 | 12.12.2017 |
| 8.12.2017 | Oncaspar | Baxalta Innovations GmbH
  Industriestraße 67, 1221 Wien, Österreich | EU/1/15/1070 | 14.12.2017 |
| 8.12.2017 | Perjeta | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/13/813 | 13.12.2017 |
| 8.12.2017 | Selincro | H. Lundbeck A/S
  Ottiliavej 9, 2500 Valby, Danmark | EU/1/12/815 | 12.12.2017 |
| 8.12.2017 | Taltz | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/15/1085 | 12.12.2017 |
| 8.12.2017 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 13.12.2017 |
| 8.12.2017 | Truberzi | Allergan Pharmaceuticals International Limited
  Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland | EU/1/16/1126 | 12.12.2017 |
| 8.12.2017 | Xiapex | Swedish Orphan Biovitrum AB (publ)
  112 76 Stockholm, Sverige | EU/1/11/671 | 12.12.2017 |
| 8.12.2017 | Zevalin | Spectrum Pharmaceuticals B.V.
  Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland | EU/1/03/264 | 12.12.2017 |
| 11.12.2017 | EVOTAZ | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1025 | 13.12.2017 |
| 11.12.2017 | Holoclar | Chiesi Farmaceutici S.p.A.
  Via Palermo 26/A, 43122 Parma, Italia | EU/1/14/987 | 13.12.2017 |
| 11.12.2017 | Neupro | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/05/331 | 13.12.2017 |
| 11.12.2017 | Odefsey | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/16/1112 | 13.12.2017 |
| 11.12.2017 | Rapiscan | GE Healthcare AS
  Nycoveien 1, 0485, Oslo, Norge | EU/1/10/643 | 15.12.2017 |
| 11.12.2017 | Reyataz | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/03/267 | 13.12.2017 |
| 11.12.2017 | Strensiq | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | 13.12.2017 |
| 11.12.2017 | Tarceva | Roche Registration Limited
  6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom | EU/1/05/311 | 13.12.2017 |
| 11.12.2017 | Zyclara | Meda AB
  Pipers väg 2A, 170 73 Solna, Sverige | EU/1/12/783 | 13.12.2017 |
| 15.12.2017 | Actelsar HCT | Actavis Group PTC ehf.
  Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland | EU/1/13/817 | 19.12.2017 |
| 15.12.2017 | ADCETRIS | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/12/794 | 19.12.2017 |
| 15.12.2017 | Efficib | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/457 | 19.12.2017 |
| 15.12.2017 | Eviplera | Gilead Sciences International Limited
  Cambridge CB21 6GT, United Kingdom | EU/1/11/737 | 19.12.2017 |
| 15.12.2017 | Janumet | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/455 | 19.12.2017 |
| 15.12.2017 | M-M-RVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/337 | 19.12.2017 |
| 15.12.2017 | Procysbi | Chiesi Orphan B.V.
  Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland | EU/1/13/861 | 19.12.2017 |
| 15.12.2017 | Ristaben | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/621 | 19.12.2017 |
| 15.12.2017 | Ristfor | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/10/620 | 19.12.2017 |
| 15.12.2017 | Stocrin | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/99/111 | 19.12.2017 |
| 15.12.2017 | Sustiva | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/99/110 | 19.12.2017 |
| 15.12.2017 | Velmetia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/08/456 | 19.12.2017 |
| 18.12.2017 | Daklinza | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/14/939 | 20.12.2017 |
| 18.12.2017 | Enbrel | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/99/126 | 20.12.2017 |
| 18.12.2017 | HBVAXPRO | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/01/183 | 20.12.2017 |
| 18.12.2017 | NovoMix | Novo Nordisk A/S
  Novo Allé, 2880 Bagsvaerd, Danmark | EU/1/00/142 | 20.12.2017 |
| 18.12.2017 | ProQuad | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/05/323 | 20.12.2017 |
| 18.12.2017 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 20.12.2017 |
| 20.12.2017 | Azilect | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/04/304 | 22.12.2017 |
| 20.12.2017 | Duloxetine Lilly | Eli Lilly Nederland B.V.
  Papendorpseweg 83, 3528 BJ Utrecht, Nederland | EU/1/14/972 | 22.12.2017 |
| 20.12.2017 | Ebymect | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/15/1051 | 22.12.2017 |
| 20.12.2017 | Efient | Daiichi Sankyo Europe GmbH
  Zielstattstraße 48, 81379 München, Deutschland | EU/1/08/503 | 22.12.2017 |
| 20.12.2017 | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, 1411 DD Naarden, Nederland | EU/1/01/188 | 22.12.2017 |
| 20.12.2017 | Gardasil | MSD VACCINS
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/06/357 | 22.12.2017 |
| 20.12.2017 | Incresync | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/13/842 | 20.12.2017 |
| 20.12.2017 | Insulin Human Winthrop | Sanofi-Aventis Deutschland GmbH
  D-65926 Frankfurt am Main, Deutschland | EU/1/06/368 | 2.1.2018 |
| 20.12.2017 | Levetiracetam ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, 89079 Ulm, Deutschland | EU/1/11/702 | 22.12.2017 |
| 20.12.2017 | Levetiracetam SUN | Sun Pharmaceutical Industries Europe BV
  Polarisavenue 87, 2132 JH Hoofddorp, Nederland | EU/1/11/741 | 22.12.2017 |
| 20.12.2017 | Qtern | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/16/1108 | 22.12.2017 |
| 20.12.2017 | Ranexa | Menarini International Operations Luxembourg S.A.
  1 avenue de la Gare, 1611 Luxembourg, Grand-Duché de Luxembourg | EU/1/08/462 | 22.12.2017 |
| 20.12.2017 | Tivicay | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/13/892 | 22.12.2017 |
| 20.12.2017 | Xigduo | AstraZeneca AB
  151 85 Södertälje, Sverige | EU/1/13/900 | 22.12.2017 |

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

1.12.2017

Alecensa

Roche Registration Limited

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

EU/1/16/1169

5.12.2017

1.12.2017

Hetlioz

Vanda Pharmaceuticals Limited

25 Old Broad Street, level 21a, London EC2N 1HQ, United Kingdom

EU/1/15/1008

5.12.2017

1.12.2017

Jakavi

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/12/773

5.12.2017

1.12.2017

OCALIVA

Intercept Pharma Ltd

2 Pancras Square, London N1C 4AG, United Kingdom

EU/1/16/1139

5.12.2017

1.12.2017

Thymanax

Servier (Ireland) Industries Limited

Gorey Road, Arklow, Co. Wicklow, Ireland

EU/1/08/498

5.12.2017

8.12.2017

Ceplene

Noventia Pharma Srl

Via Carlo Pisacane 31, 47121 Forli, Italia

EU/1/08/477

12.12.2017

8.12.2017

Dexdor

Orion Corporation

Orionintie 1, 02200 Espoo, Suomi

EU/1/11/718

12.12.2017

8.12.2017

Esbriet

Roche Registration Limited

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

EU/1/11/667

13.12.2017

8.12.2017

Esmya

Gedeon Richter Plc.

Gyömrői út 19-21., 1103 Budapest, Magyarország

EU/1/12/750

12.12.2017

8.12.2017

Genvoya

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/15/1061

12.12.2017

8.12.2017

GILENYA

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/677

13.12.2017

8.12.2017

Humira

AbbVie Ltd

Abbvie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire SL6 4UB, United Kingdom

EU/1/03/256

12.12.2017

8.12.2017

Januvia

Merck Sharp & Dohme Limited

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

EU/1/07/383

13.12.2017

8.12.2017

JETREA

ThromboGenics NV

Gaston Geenslaan 1, 3001 Leuven, België

EU/1/13/819

12.12.2017

8.12.2017

KEYTRUDA

Merck Sharp & Dohme Limited

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

EU/1/15/1024

13.12.2017

8.12.2017

Leganto

UCB Manufacturing Ireland Ltd

Shannon Industrial Estate, Co, Clare, Ireland

EU/1/11/695

12.12.2017

8.12.2017

Lemtrada

Genzyme Therapeutics Ltd

4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom

EU/1/13/869

13.12.2017

8.12.2017

Moventig

Kyowa Kirin Limited

Galabank Business Park, Galashiels, TD1 1QH, United Kingdom

EU/1/14/962

12.12.2017

8.12.2017

Mysimba

Orexigen Therapeutics Ireland Limited

2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland

EU/1/14/988

12.12.2017

8.12.2017

Oncaspar

Baxalta Innovations GmbH

Industriestraße 67, 1221 Wien, Österreich

EU/1/15/1070

14.12.2017

8.12.2017

Perjeta

Roche Registration Limited

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

EU/1/13/813

13.12.2017

8.12.2017

Selincro

H. Lundbeck A/S

Ottiliavej 9, 2500 Valby, Danmark

EU/1/12/815

12.12.2017

8.12.2017

Taltz

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/15/1085

12.12.2017

8.12.2017

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

13.12.2017

8.12.2017

Truberzi

Allergan Pharmaceuticals International Limited

Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland

EU/1/16/1126

12.12.2017

8.12.2017

Xiapex

Swedish Orphan Biovitrum AB (publ)

112 76 Stockholm, Sverige

EU/1/11/671

12.12.2017

8.12.2017

Zevalin

Spectrum Pharmaceuticals B.V.

Prins Bernhardplein 200, 1097 JB Amsterdam, Nederland

EU/1/03/264

12.12.2017

11.12.2017

EVOTAZ

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1025

13.12.2017

11.12.2017

Holoclar

Chiesi Farmaceutici S.p.A.

Via Palermo 26/A, 43122 Parma, Italia

EU/1/14/987

13.12.2017

11.12.2017

Neupro

UCB Pharma S.A.

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

EU/1/05/331

13.12.2017

11.12.2017

Odefsey

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/16/1112

13.12.2017

11.12.2017

Rapiscan

GE Healthcare AS

Nycoveien 1, 0485, Oslo, Norge

EU/1/10/643

15.12.2017

11.12.2017

Reyataz

Bristol-Myers Squibb Pharma EEIG

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

EU/1/03/267

13.12.2017

11.12.2017

Strensiq

Alexion Europe SAS

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

EU/1/15/1015

13.12.2017

11.12.2017

Tarceva

Roche Registration Limited

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

EU/1/05/311

13.12.2017

11.12.2017

Zyclara

Meda AB

Pipers väg 2A, 170 73 Solna, Sverige

EU/1/12/783

13.12.2017

15.12.2017

Actelsar HCT

Actavis Group PTC ehf.

Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland

EU/1/13/817

19.12.2017

15.12.2017

ADCETRIS

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/12/794

19.12.2017

15.12.2017

Efficib

Merck Sharp & Dohme Limited

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

EU/1/08/457

19.12.2017

15.12.2017

Eviplera

Gilead Sciences International Limited

Cambridge CB21 6GT, United Kingdom

EU/1/11/737

19.12.2017

15.12.2017

Janumet

Merck Sharp & Dohme Limited

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

EU/1/08/455

19.12.2017

15.12.2017

M-M-RVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/337

19.12.2017

15.12.2017

Procysbi

Chiesi Orphan B.V.

Graadt van Roggenweg 340, 3531 AH Utrecht, Nederland

EU/1/13/861

19.12.2017

15.12.2017

Ristaben

Merck Sharp & Dohme Limited

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

EU/1/10/621

19.12.2017

15.12.2017

Ristfor

Merck Sharp & Dohme Limited

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

EU/1/10/620

19.12.2017

15.12.2017

Stocrin

Merck Sharp & Dohme Limited

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

EU/1/99/111

19.12.2017

15.12.2017

Sustiva

Bristol-Myers Squibb Pharma EEIG

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

EU/1/99/110

19.12.2017

15.12.2017

Velmetia

Merck Sharp & Dohme Limited

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

EU/1/08/456

19.12.2017

18.12.2017

Daklinza

Bristol-Myers Squibb Pharma EEIG

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

EU/1/14/939

20.12.2017

18.12.2017

Enbrel

Pfizer Limited

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

EU/1/99/126

20.12.2017

18.12.2017

HBVAXPRO

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/01/183

20.12.2017

18.12.2017

NovoMix

Novo Nordisk A/S

Novo Allé, 2880 Bagsvaerd, Danmark

EU/1/00/142

20.12.2017

18.12.2017

ProQuad

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/05/323

20.12.2017

18.12.2017

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

20.12.2017

20.12.2017

Azilect

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/04/304

22.12.2017

20.12.2017

Duloxetine Lilly

Eli Lilly Nederland B.V.

Papendorpseweg 83, 3528 BJ Utrecht, Nederland

EU/1/14/972

22.12.2017

20.12.2017

Ebymect

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/15/1051

22.12.2017

20.12.2017

Efient

Daiichi Sankyo Europe GmbH

Zielstattstraße 48, 81379 München, Deutschland

EU/1/08/503

22.12.2017

20.12.2017

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, 1411 DD Naarden, Nederland

EU/1/01/188

22.12.2017

20.12.2017

Gardasil

MSD VACCINS

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/06/357

22.12.2017

20.12.2017

Incresync

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/13/842

20.12.2017

20.12.2017

Insulin Human Winthrop

Sanofi-Aventis Deutschland GmbH

D-65926 Frankfurt am Main, Deutschland

EU/1/06/368

2.1.2018

20.12.2017

Levetiracetam ratiopharm

ratiopharm GmbH

Graf-Arco-Straße 3, 89079 Ulm, Deutschland

EU/1/11/702

22.12.2017

20.12.2017

Levetiracetam SUN

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87, 2132 JH Hoofddorp, Nederland

EU/1/11/741

22.12.2017

20.12.2017

Qtern

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/16/1108

22.12.2017

20.12.2017

Ranexa

Menarini International Operations Luxembourg S.A.

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

EU/1/08/462

22.12.2017

20.12.2017

Tivicay

ViiV Healthcare UK Limited

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

EU/1/13/892

22.12.2017

20.12.2017

Xigduo

AstraZeneca AB

151 85 Södertälje, Sverige

EU/1/13/900

22.12.2017

—   Issuing of a marketing authorization (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 | 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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 1.12.2017 | Rabitec | Rabies vaccine (live, oral) for foxes and raccoon dogs | IDT Biologika GmbH
  Am Pharmapark, 06861 Dessau-Rosslau, Deutschland | EU/2/17/219 | Oral suspension | QI07BD | 5.12.2017 |

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

1.12.2017

Rabitec

Rabies vaccine (live, oral) for foxes and raccoon dogs

IDT Biologika GmbH

Am Pharmapark, 06861 Dessau-Rosslau, Deutschland

EU/2/17/219

Oral suspension

QI07BD

5.12.2017

—   Modification of a marketing authorization (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 authorization | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 6.12.2017 | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | 8.12.2017 |
| 6.12.2017 | Spironolactone Ceva | Ceva Santé Animale
  10 avenue de la Ballastière, 33500 Libourne, France | EU/2/07/074 | 8.12.2017 |
| 18.12.2017 | Sedadex | Le Vet Beheer B.V.
  Wilgenweg 7, 3421 TV Oudewater, Nederland | EU/2/16/198 | 20.12.2017 |
| 20.12.2017 | Easotic | VIRBAC S.A.
  1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/08/085 | 22.12.2017 |
| 20.12.2017 | Leucogen | Virbac
  1ère Avenue — 2065 m — L.I.D., 06516 Carros Cedex, France | EU/2/09/096 | 22.12.2017 |

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

6.12.2017

Kexxtone

Eli Lilly and Company Limited

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

EU/2/12/145

8.12.2017

6.12.2017

Spironolactone Ceva

Ceva Santé Animale

10 avenue de la Ballastière, 33500 Libourne, France

EU/2/07/074

8.12.2017

18.12.2017

Sedadex

Le Vet Beheer B.V.

Wilgenweg 7, 3421 TV Oudewater, Nederland

EU/2/16/198

20.12.2017

20.12.2017

Easotic

VIRBAC S.A.

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

EU/2/08/085

22.12.2017

20.12.2017

Leucogen

Virbac

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

EU/2/09/096

22.12.2017

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.

---

| 26.1.2018 | EN | Official Journal of the European Union | C 30/10 |
| --- | --- | --- | --- |

26.1.2018

EN

Official Journal of the European Union

C 30/10

---

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

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

(2018/C 030/02)

—   Refusal of a national marketing authorization

| Date of the decision | Name(s) of the medicinal product | INN (International Non-Proprietary Name) | Holder(s) of the marketing authorization | Member State concerned | Date of notification |
| --- | --- | --- | --- | --- | --- |
| 18.12.2017 | Alcover and associated names — Art 29 | Sodium oxybate | — | — | 19.12.2017 |

Date of the decision

Name(s) of the medicinal product

INN (International Non-Proprietary Name)

Holder(s) of the marketing authorization

Member State concerned

Date of notification

18.12.2017

Alcover and associated names — Art 29

Sodium oxybate

—

—

19.12.2017

---

(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.

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