# Official Journal C 252/31 J

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 252 |
| | |
| English edition | Information and Notices | Volume 5831 July 2015 |

ISSN 1977-091X

Official Journal

of the European Union

C 252

English edition

Information and Notices

Volume 5831 July 2015

---

| Notice No | Contents | page |
| --- | --- | --- |
| | IV   Notices |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2015/C 252/01 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) | 1 |
| 2015/C 252/02 | Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015(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

2015/C 252/01

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015(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

2015/C 252/02

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015(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

| 31.7.2015 | EN | Official Journal of the European Union | C 252/1 |
| --- | --- | --- | --- |

31.7.2015

EN

Official Journal of the European Union

C 252/1

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015

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

(2015/C 252/01)

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.6.2015 | Gardasil 9 | Human papillomavirus 9-valent vaccine (recombinant, adsorbed) | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/15/1007 | Suspension for injection | J07BM03 | 12.6.2015 |
| 19.6.2015 | Duloxetine Mylan | Duloxetine | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/1010 | Gastro-resistant capsule, hard | N06AX21 | 24.6.2015 |
| 19.6.2015 | Lixiana | Edoxaban | Daiichi Sankyo Europe GmbH
  Zielstattstrasse 48, 81379 Munich, Deutschland | EU/1/15/993 | Film-coated tablet | B01 | 23.6.2015 |
| 19.6.2015 | Lumark | Lutetium, isotope of mass 177 | IDB Radiopharmacy B.V.
  Weverstraat 17, 5111 PV Baarle-Nassau, Nederland | EU/1/15/1013 | Radiopharmaceutical precursor, solution | Pending | 23.6.2015 |
| 19.6.2015 | Opdivo | Nivolumab | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/15/1014 | Concentrate for solution for infusion | L01XC17 | 24.6.2015 |
| 19.6.2015 | Pregabalin Sandoz | Pregabalin | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1011 | Capsule, hard | N03AX16 | 23.6.2015 |
| 19.6.2015 | Pregabalin Sandoz GmbH | Pregabalin | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1012 | Capsule, hard | N03AX16 | 23.6.2015 |
| 25.6.2015 | Aripiprazole Zentiva | Aripiprazole | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1009 | Orodispersible tablet
  Tablet | N05AX12 | 29.6.2015 |
| 25.6.2015 | Pregabalin Mylan | Pregabalin | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/997 | Capsule, hard | N03AX16 | 30.6.2015 |
| 25.6.2015 | Pregabalin Mylan Pharma | Pregabalin | Generics [UK] Limited
  Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom | EU/1/15/998 | Capsule, hard | N03AX16 | 29.6.2015 |
| 30.6.2015 | Aripiprazole Pharmathen | Aripiprazole | Pharmathen S.A.
  6 Dervenakion, 15351 Pallini Attiki, Ελλάδα | EU/1/15/1005 | Tablet | N05AX12 | 2.7.2015 |

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

10.6.2015

Gardasil 9

Human papillomavirus 9-valent vaccine (recombinant, adsorbed)

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/15/1007

Suspension for injection

J07BM03

12.6.2015

19.6.2015

Duloxetine Mylan

Duloxetine

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/1010

Gastro-resistant capsule, hard

N06AX21

24.6.2015

19.6.2015

Lixiana

Edoxaban

Daiichi Sankyo Europe GmbH

Zielstattstrasse 48, 81379 Munich, Deutschland

EU/1/15/993

Film-coated tablet

B01

23.6.2015

19.6.2015

Lumark

Lutetium, isotope of mass 177

IDB Radiopharmacy B.V.

Weverstraat 17, 5111 PV Baarle-Nassau, Nederland

EU/1/15/1013

Radiopharmaceutical precursor, solution

Pending

23.6.2015

19.6.2015

Opdivo

Nivolumab

Bristol-Myers Squibb Pharma EEIG

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

EU/1/15/1014

Concentrate for solution for infusion

L01XC17

24.6.2015

19.6.2015

Pregabalin Sandoz

Pregabalin

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1011

Capsule, hard

N03AX16

23.6.2015

19.6.2015

Pregabalin Sandoz GmbH

Pregabalin

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1012

Capsule, hard

N03AX16

23.6.2015

25.6.2015

Aripiprazole Zentiva

Aripiprazole

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1009

Orodispersible tablet

Tablet

N05AX12

29.6.2015

25.6.2015

Pregabalin Mylan

Pregabalin

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/997

Capsule, hard

N03AX16

30.6.2015

25.6.2015

Pregabalin Mylan Pharma

Pregabalin

Generics [UK] Limited

Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

EU/1/15/998

Capsule, hard

N03AX16

29.6.2015

30.6.2015

Aripiprazole Pharmathen

Aripiprazole

Pharmathen S.A.

6 Dervenakion, 15351 Pallini Attiki, Ελλάδα

EU/1/15/1005

Tablet

N05AX12

2.7.2015

—   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 |
| --- | --- | --- | --- | --- |
| 2.6.2015 | Mirvaso | Galderma International
  Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France | EU/1/13/904 | 4.6.2015 |
| 2.6.2015 | Optimark | Mallinckrodt Deutschland GmbH
  Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland | EU/1/07/398 | 5.6.2015 |
| 5.6.2015 | Kolbam | Retrophin Europe Limited
  25/28 North Wall Quay, Dublin 1, Ireland | EU/1/13/895 | 9.6.2015 |
| 5.6.2015 | Xelevia | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/382 | 9.6.2015 |
| 10.6.2015 | CANCIDAS | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/01/196 | 12.6.2015 |
| 10.6.2015 | Clopidogrel Krka d.d. | Krka, d. d., Novo Mesto
  Šmarješka cesta 6, 8501 Novo mesto, Slovenija | EU/1/09/562 | 12.6.2015 |
| 10.6.2015 | Tesavel | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/07/435 | 12.6.2015 |
| 11.6.2015 | Adjupanrix | GlaxoSmithKline Biologicals S.A.
  rue de l'Institut 89, 1330 Rixensart, Belgique | EU/1/09/578 | 16.6.2015 |
| 11.6.2015 | IKERVIS | Santen Oy
  Niittyhaankatu 20, FI-33720 Tampere, Suomi | EU/1/15/990 | 15.6.2015 |
| 11.6.2015 | Insulatard | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/233 | 15.6.2015 |
| 11.6.2015 | Pramipexole Accord | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/11/728 | 12.6.2015 |
| 11.6.2015 | Protaphane | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/234 | 15.6.2015 |
| 16.6.2015 | Clopidogrel HCS | HCS bvba
  H. Kennisstraat 53, B-2650 Edegem, België | EU/1/10/651 | 18.6.2015 |
| 19.6.2015 | Actos | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/150 | 23.6.2015 |
| 19.6.2015 | Actrapid | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/02/230 | 23.6.2015 |
| 19.6.2015 | APTIVUS | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/05/315 | 23.6.2015 |
| 19.6.2015 | AUBAGIO | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/13/838 | 23.6.2015 |
| 19.6.2015 | DuoTrav | Alcon Laboratories (UK) Ltd
  Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom | EU/1/06/338 | 24.6.2015 |
| 19.6.2015 | Eperzan | GlaxoSmithKline Trading Services Limited
  Currabinny, Carrigaline, County Cork, Ireland | EU/1/13/908 | 23.6.2015 |
| 19.6.2015 | Fabrazyme | Genzyme Europe B.V.
  Gooimeer 10, NL-1411 DD Naarden, Nederland | EU/1/01/188 | 23.7.2015 |
| 19.6.2015 | Glustin | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/00/151 | 23.6.2015 |
| 19.6.2015 | Leflunomide ratiopharm | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/10/654 | 23.6.2015 |
| 19.6.2015 | Orfadin | Swedish Orphan Biovitrum International AB
  SE-112 76 Stockholm, Sverige | EU/1/04/303 | 23.6.2015 |
| 19.6.2015 | Rasilamlo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/686 | 24.6.2015 |
| 19.6.2015 | Rasilez | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/405 | 24.6.2015 |
| 19.6.2015 | SonoVue | Bracco International B.V.
  Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland | EU/1/01/177 | 23.6.2015 |
| 19.6.2015 | Telmisartan Actavis | Actavis Group PTC ehf.
  Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland | EU/1/10/639 | 23.6.2015 |
| 19.6.2015 | Tyverb | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/07/440 | 24.6.2015 |
| 19.6.2015 | VPRIV | Shire Pharmaceuticals Ireland Limited
  5 River Walk, Citywest Business Campus, Dublin 24, Ireland | EU/1/10/646 | 23.6.2015 |
| 19.6.2015 | Yervoy | Bristol-Myers Squibb Pharma EEIG
  Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom | EU/1/11/698 | 23.6.2015 |
| 19.6.2015 | Yondelis | Pharma Mar S.A.
  Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España | EU/1/07/417 | 23.6.2015 |
| 22.6.2015 | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Brussels, Belgique | EU/1/07/420 | 24.6.2015 |
| 22.6.2015 | Fycompa | Eisai Europe Limited
  European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom | EU/1/12/776 | 24.6.2015 |
| 22.6.2015 | JEVTANA | Sanofi-Aventis groupe
  54 rue La Boétie, F-75008 Paris, France | EU/1/11/676 | 24.6.2015 |
| 22.6.2015 | Kivexa | ViiV Healthcare UK Limited
  980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom | EU/1/04/298 | 24.6.2015 |
| 22.6.2015 | Kuvan | Merck Serono Europe Limited
  56, Marsh Wall, London E14 9TP, United Kingdom | EU/1/08/481 | 24.6.2015 |
| 22.6.2015 | Prevenar | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/00/167 | 25.6.2015 |
| 22.6.2015 | Rasilez HCT | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/08/491 | 24.6.2015 |
| 22.6.2015 | Simponi | Janssen Biologics B.V.
  Einsteinweg 101, NL-2333 CB Leiden, Nederland | EU/1/09/546 | 24.6.2015 |
| 22.6.2015 | Stelara | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/08/494 | 24.6.2015 |
| 22.6.2015 | Xolair | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/05/319 | 24.6.2015 |
| 22.6.2015 | Xtandi | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/13/846 | 24.6.2015 |
| 25.6.2015 | Ibandronic Acid Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/10/642 | 29.6.2015 |
| 25.6.2015 | Xultophy | Novo Nordisk A/S
  Novo Allé, DK-2880 Bagsvaerd, Danmark | EU/1/14/947 | 29.6.2015 |
| 30.6.2015 | Prolia | Amgen Europe B.V.
  Minervum 7061, NL-4817 ZK Breda, Nederland | EU/1/10/618 | 2.7.2015 |

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

2.6.2015

Mirvaso

Galderma International

Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France

EU/1/13/904

4.6.2015

2.6.2015

Optimark

Mallinckrodt Deutschland GmbH

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

EU/1/07/398

5.6.2015

5.6.2015

Kolbam

Retrophin Europe Limited

25/28 North Wall Quay, Dublin 1, Ireland

EU/1/13/895

9.6.2015

5.6.2015

Xelevia

Merck Sharp & Dohme Limited

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

EU/1/07/382

9.6.2015

10.6.2015

CANCIDAS

Merck Sharp & Dohme Limited

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

EU/1/01/196

12.6.2015

10.6.2015

Clopidogrel Krka d.d.

Krka, d. d., Novo Mesto

Šmarješka cesta 6, 8501 Novo mesto, Slovenija

EU/1/09/562

12.6.2015

10.6.2015

Tesavel

Merck Sharp & Dohme Limited

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

EU/1/07/435

12.6.2015

11.6.2015

Adjupanrix

GlaxoSmithKline Biologicals S.A.

rue de l'Institut 89, 1330 Rixensart, Belgique

EU/1/09/578

16.6.2015

11.6.2015

IKERVIS

Santen Oy

Niittyhaankatu 20, FI-33720 Tampere, Suomi

EU/1/15/990

15.6.2015

11.6.2015

Insulatard

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/233

15.6.2015

11.6.2015

Pramipexole Accord

Accord Healthcare Limited

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

EU/1/11/728

12.6.2015

11.6.2015

Protaphane

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/234

15.6.2015

16.6.2015

Clopidogrel HCS

HCS bvba

H. Kennisstraat 53, B-2650 Edegem, België

EU/1/10/651

18.6.2015

19.6.2015

Actos

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/150

23.6.2015

19.6.2015

Actrapid

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/02/230

23.6.2015

19.6.2015

APTIVUS

Boehringer Ingelheim International GmbH

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

EU/1/05/315

23.6.2015

19.6.2015

AUBAGIO

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/13/838

23.6.2015

19.6.2015

DuoTrav

Alcon Laboratories (UK) Ltd

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom

EU/1/06/338

24.6.2015

19.6.2015

Eperzan

GlaxoSmithKline Trading Services Limited

Currabinny, Carrigaline, County Cork, Ireland

EU/1/13/908

23.6.2015

19.6.2015

Fabrazyme

Genzyme Europe B.V.

Gooimeer 10, NL-1411 DD Naarden, Nederland

EU/1/01/188

23.7.2015

19.6.2015

Glustin

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/00/151

23.6.2015

19.6.2015

Leflunomide ratiopharm

ratiopharm GmbH

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

EU/1/10/654

23.6.2015

19.6.2015

Orfadin

Swedish Orphan Biovitrum International AB

SE-112 76 Stockholm, Sverige

EU/1/04/303

23.6.2015

19.6.2015

Rasilamlo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/686

24.6.2015

19.6.2015

Rasilez

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/405

24.6.2015

19.6.2015

SonoVue

Bracco International B.V.

Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland

EU/1/01/177

23.6.2015

19.6.2015

Telmisartan Actavis

Actavis Group PTC ehf.

Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland

EU/1/10/639

23.6.2015

19.6.2015

Tyverb

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/07/440

24.6.2015

19.6.2015

VPRIV

Shire Pharmaceuticals Ireland Limited

5 River Walk, Citywest Business Campus, Dublin 24, Ireland

EU/1/10/646

23.6.2015

19.6.2015

Yervoy

Bristol-Myers Squibb Pharma EEIG

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

EU/1/11/698

23.6.2015

19.6.2015

Yondelis

Pharma Mar S.A.

Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España

EU/1/07/417

23.6.2015

22.6.2015

Cyanokit

SERB S.A.

Avenue Louise 480, 1050 Brussels, Belgique

EU/1/07/420

24.6.2015

22.6.2015

Fycompa

Eisai Europe Limited

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

EU/1/12/776

24.6.2015

22.6.2015

JEVTANA

Sanofi-Aventis groupe

54 rue La Boétie, F-75008 Paris, France

EU/1/11/676

24.6.2015

22.6.2015

Kivexa

ViiV Healthcare UK Limited

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

EU/1/04/298

24.6.2015

22.6.2015

Kuvan

Merck Serono Europe Limited

56, Marsh Wall, London E14 9TP, United Kingdom

EU/1/08/481

24.6.2015

22.6.2015

Prevenar

Pfizer Limited

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

EU/1/00/167

25.6.2015

22.6.2015

Rasilez HCT

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/08/491

24.6.2015

22.6.2015

Simponi

Janssen Biologics B.V.

Einsteinweg 101, NL-2333 CB Leiden, Nederland

EU/1/09/546

24.6.2015

22.6.2015

Stelara

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/08/494

24.6.2015

22.6.2015

Xolair

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/05/319

24.6.2015

22.6.2015

Xtandi

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/13/846

24.6.2015

25.6.2015

Ibandronic Acid Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/10/642

29.6.2015

25.6.2015

Xultophy

Novo Nordisk A/S

Novo Allé, DK-2880 Bagsvaerd, Danmark

EU/1/14/947

29.6.2015

30.6.2015

Prolia

Amgen Europe B.V.

Minervum 7061, NL-4817 ZK Breda, Nederland

EU/1/10/618

2.7.2015

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

| 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 |
| --- | --- | --- | --- | --- |
| 25.6.2015 | Rasilamlo | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/11/686 | 29.6.2015 |

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

25.6.2015

Rasilamlo

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/11/686

29.6.2015

—   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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 10.6.2015 | Sileo | Dexmedetomidine hydrochloride | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/2/15/181 | Oromucosal gel | QN05CM18 | 12.6.2015 |

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

10.6.2015

Sileo

Dexmedetomidine hydrochloride

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/2/15/181

Oromucosal gel

QN05CM18

12.6.2015

—   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 |
| --- | --- | --- | --- | --- |
| 5.6.2015 | Bovilis BTV8 | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/10/106 | 9.6.2015 |
| 5.6.2015 | Equisolon | Le Vet B.V.
  Wilgenweg 7, NL-3421 TV Oudewater, Nederland | EU/2/14/161 | 9.6.2015 |
| 5.6.2015 | Recuvyra | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/11/127 | 9.6.2015 |
| 10.6.2015 | Cerenia | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/06/062 | 12.6.2015 |
| 10.6.2015 | Equilis Te | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/05/055 | 12.6.2015 |
| 10.6.2015 | Kexxtone | Eli Lilly and Company Limited
  Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom | EU/2/12/145 | 12.6.2015 |
| 10.6.2015 | Previcox | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/04/045 | 12.6.2015 |
| 11.6.2015 | Prac-Tic | Novartis Sanidad Animal S.L.
  Calle de la Marina, 206, E-08013 Barcelona, España | EU/2/06/066 | 12.6.2015 |
| 19.6.2015 | Profender | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/05/054 | 23.6.2015 |
| 30.6.2015 | Rhiniseng | Laboratorios Hipra, S.A.
  Avda. La Selva, 135, E-17170- Amer (Girona), España | EU/2/10/109 | 2.7.2015 |

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

5.6.2015

Bovilis BTV8

Intervet International B.V.

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

EU/2/10/106

9.6.2015

5.6.2015

Equisolon

Le Vet B.V.

Wilgenweg 7, NL-3421 TV Oudewater, Nederland

EU/2/14/161

9.6.2015

5.6.2015

Recuvyra

Eli Lilly and Company Limited

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

EU/2/11/127

9.6.2015

10.6.2015

Cerenia

Zoetis Belgium S.A.

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

EU/2/06/062

12.6.2015

10.6.2015

Equilis Te

Intervet International B.V.

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

EU/2/05/055

12.6.2015

10.6.2015

Kexxtone

Eli Lilly and Company Limited

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

EU/2/12/145

12.6.2015

10.6.2015

Previcox

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/04/045

12.6.2015

11.6.2015

Prac-Tic

Novartis Sanidad Animal S.L.

Calle de la Marina, 206, E-08013 Barcelona, España

EU/2/06/066

12.6.2015

19.6.2015

Profender

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/05/054

23.6.2015

30.6.2015

Rhiniseng

Laboratorios Hipra, S.A.

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

EU/2/10/109

2.7.2015

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

| The European Medicines Agency |
| --- |
| 30, Churchill Place, Canary Wharf |
| UK — LONDON E14 5EU |

The European Medicines Agency

30, Churchill Place, Canary Wharf

UK — LONDON E14 5EU

---

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

---

| 31.7.2015 | EN | Official Journal of the European Union | C 252/10 |
| --- | --- | --- | --- |

31.7.2015

EN

Official Journal of the European Union

C 252/10

---

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015

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

(2015/C 252/02)

| 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 |
| --- | --- | --- | --- | --- | --- |
| 5.6.2015 | Ikorel and Dancor | See Annex I | See Annex I | See Annex I | 6.6.2015 |
| 25.6.2015 | Merisone | See Annex II | See Annex II | See Annex II | 26.6.2015 |
| 25.6.2015 | Myoson | See Annex III | See Annex III | See Annex III | 26.6.2015 |

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

5.6.2015

Ikorel and Dancor

See Annex I

See Annex I

See Annex I

6.6.2015

25.6.2015

Merisone

See Annex II

See Annex II

See Annex II

26.6.2015

25.6.2015

Myoson

See Annex III

See Annex III

See Annex III

26.6.2015

---

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

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

---

ANNEX I

List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, Marketing Authorisation Holders in the Member States

| Member State (in EEA) | Marketing authorisation holder | Invented Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Austria | MERCK Gesellschaft mbH
  Zimbagasse 5
  1147 Wien
  Austria | Dancor 10 mg — Tabletten | 10 mg | tablet | oral use |
| Austria | MERCK Gesellschaft mbH
  Zimbagasse 5
  1147 Wien
  Austria | Dancor 20 mg — Tabletten | 20 mg | tablet | oral use |
| Denmark | Sanofi-Aventis Denmark A/S
  Slotsmarken 13
  DK-2970 Hørsholm
  Denmark | ANGICOR | 10 mg | tablet | oral use |
| Denmark | Sanofi-Aventis Denmark A/S
  Slotsmarken 13
  DK-2970 Hørsholm
  Denmark | ANGICOR | 20 mg | tablet | oral use |
| France | Sanofi-Aventis France
  1-13 boulevard Romain Rolland
  75014 Paris
  France | IKOREL | 10 mg | scored tablet | oral use |
| France | Sanofi-Aventis France
  1-13 boulevard Romain Rolland
  75014 Paris
  France | IKOREL | 20 mg | tablet | oral use |
| France | Sanofi-Aventis France
  1-13 boulevard Romain Rolland
  75014 Paris
  France | NICORANDIL ZENTIVA | 10 mg | scored tablet | oral use |
| France | Sanofi-Aventis France
  1-13 boulevard Romain Rolland
  75014 Paris
  France | NICORANDIL ZENTIVA | 20 mg | tablet | oral use |
| France | Merck Santé
  37, Rue Saint-Romain
  69379 Lyon Cedex 08
  France | Adancor | 10 mg | scored tablet | oral use |
| France | Merck Santé
  37, Rue Saint-Romain
  69379 Lyon Cedex 08
  France | Adancor | 20 mg | tablet | oral use |
| Ireland | Sanofi-Aventis Ireland L Ltd., T/A SANOFI
  Citywest Business Campus Dublin 24
  Ireland | IKOREL | 10 mg | tablet | oral use |
| Ireland | Sanofi-Aventis Ireland L Ltd., T/A SANOFI
  Citywest Business Campus Dublin 24
  Ireland | IKOREL | 20 mg | tablet | oral use |
| Netherlands | Sanofi-Aventis Netherlands B.V.
  Kampenringweg 45 D-E Gouda
  Netherlands | IKOREL 10 mg | 10 mg | tablet | oral use |
| Portugal | Merck, S.A.
  Edifício DUO Miraflores
  Alameda Fernão Lopes, no 12 — 4o B,
  1495-190 Algés
  Portugal | Dancor | 10 mg | tablet | oral use |
| Portugal | Merck, S.A.
  Edifício DUO Miraflores
  Alameda Fernão Lopes, no 12 — 4o B,
  1495-190 Algés
  Portugal | Dancor | 20 mg | tablet | oral use |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  UK | IKOREL | 10 mg | tablet | oral use |
| United Kingdom | Aventis Pharma Limited
  One Onslow Street
  Guildford
  Surrey
  GU1 4YS
  UK | IKOREL | 20 mg | tablet | oral use |

Member State (in EEA)

Marketing authorisation holder

Invented Name

Strength

Pharmaceutical form

Route of administration

Austria

MERCK Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Dancor 10 mg — Tabletten

10 mg

tablet

oral use

Austria

MERCK Gesellschaft mbH

Zimbagasse 5

1147 Wien

Austria

Dancor 20 mg — Tabletten

20 mg

tablet

oral use

Denmark

Sanofi-Aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

ANGICOR

10 mg

tablet

oral use

Denmark

Sanofi-Aventis Denmark A/S

Slotsmarken 13

DK-2970 Hørsholm

Denmark

ANGICOR

20 mg

tablet

oral use

France

Sanofi-Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

IKOREL

10 mg

scored tablet

oral use

France

Sanofi-Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

IKOREL

20 mg

tablet

oral use

France

Sanofi-Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

NICORANDIL ZENTIVA

10 mg

scored tablet

oral use

France

Sanofi-Aventis France

1-13 boulevard Romain Rolland

75014 Paris

France

NICORANDIL ZENTIVA

20 mg

tablet

oral use

France

Merck Santé

37, Rue Saint-Romain

69379 Lyon Cedex 08

France

Adancor

10 mg

scored tablet

oral use

France

Merck Santé

37, Rue Saint-Romain

69379 Lyon Cedex 08

France

Adancor

20 mg

tablet

oral use

Ireland

Sanofi-Aventis Ireland L Ltd., T/A SANOFI

Citywest Business Campus Dublin 24

Ireland

IKOREL

10 mg

tablet

oral use

Ireland

Sanofi-Aventis Ireland L Ltd., T/A SANOFI

Citywest Business Campus Dublin 24

Ireland

IKOREL

20 mg

tablet

oral use

Netherlands

Sanofi-Aventis Netherlands B.V.

Kampenringweg 45 D-E Gouda

Netherlands

IKOREL 10 mg

10 mg

tablet

oral use

Portugal

Merck, S.A.

Edifício DUO Miraflores

Alameda Fernão Lopes, no 12 — 4o B,

1495-190 Algés

Portugal

Dancor

10 mg

tablet

oral use

Portugal

Merck, S.A.

Edifício DUO Miraflores

Alameda Fernão Lopes, no 12 — 4o B,

1495-190 Algés

Portugal

Dancor

20 mg

tablet

oral use

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

IKOREL

10 mg

tablet

oral use

United Kingdom

Aventis Pharma Limited

One Onslow Street

Guildford

Surrey

GU1 4YS

UK

IKOREL

20 mg

tablet

oral use

---

ANNEX II

List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Germany | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H2097 Pilisborosjenő,
  Hungary | Tolperison-neuraxpharm 50 mg Filmtabletten | 50 mg | film-coated tablet | oral use |
| Germany | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H2097 Pilisborosjenő,
  Hungary | Tolperison-neuraxpharm 150 mg Filmtabletten | 150 mg | film-coated tablet | oral use |
| Hungary | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H2097 Pilisborosjenő,
  Hungary | MERISONE | 50 mg | film-coated tablet | oral use |
| Hungary | Meditop Pharmaceutical Ltd.,
  Ady Endre utca 1.
  H2097 Pilisborosjenő,
  Hungary | MERISONE | 150 mg | film-coated tablet | oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Germany

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H2097 Pilisborosjenő,

Hungary

Tolperison-neuraxpharm 50 mg Filmtabletten

50 mg

film-coated tablet

oral use

Germany

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H2097 Pilisborosjenő,

Hungary

Tolperison-neuraxpharm 150 mg Filmtabletten

150 mg

film-coated tablet

oral use

Hungary

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H2097 Pilisborosjenő,

Hungary

MERISONE

50 mg

film-coated tablet

oral use

Hungary

Meditop Pharmaceutical Ltd.,

Ady Endre utca 1.

H2097 Pilisborosjenő,

Hungary

MERISONE

150 mg

film-coated tablet

oral use

---

ANNEX III

List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States

| Member State EU/EEA | Applicant | (Invented) Name | Strength | Pharmaceutical form | Route of administration |
| --- | --- | --- | --- | --- | --- |
| Belgium | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 50 mg comprimés pelliculés | 50 mg | film-coated tablet | oral use |
| Belgium | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 150 mg comprimés pelliculés | 150 mg | film-coated tablet | oral use |
| Hungary | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | MYOSON | 50 mg | film-coated tablet | oral use |
| Hungary | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | MYOSON | 150 mg | film-coated tablet | oral use |
| Luxembourg | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Epsipam | 50 mg | film-coated tablet | oral use |
| Luxembourg | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Epsipam | 150 mg | film-coated tablet | oral use |
| The Netherlands | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 50 mg filmomhulde tabletten | 50 mg | film-coated tablet | oral use |
| The Netherlands | Meditop Pharmaceutical Ltd., Ady Endre utca 1.
  H-2097 Pilisborosjenő, Hungary | Tolpermyo 150 mg filmomhulde tabletten | 150 mg | film-coated tablet | oral use |

Member State EU/EEA

Applicant

(Invented) Name

Strength

Pharmaceutical form

Route of administration

Belgium

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 50 mg comprimés pelliculés

50 mg

film-coated tablet

oral use

Belgium

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 150 mg comprimés pelliculés

150 mg

film-coated tablet

oral use

Hungary

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

MYOSON

50 mg

film-coated tablet

oral use

Hungary

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

MYOSON

150 mg

film-coated tablet

oral use

Luxembourg

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Epsipam

50 mg

film-coated tablet

oral use

Luxembourg

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Epsipam

150 mg

film-coated tablet

oral use

The Netherlands

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 50 mg filmomhulde tabletten

50 mg

film-coated tablet

oral use

The Netherlands

Meditop Pharmaceutical Ltd., Ady Endre utca 1.

H-2097 Pilisborosjenő, Hungary

Tolpermyo 150 mg filmomhulde tabletten

150 mg

film-coated tablet

oral use

---