# C_2015318EN.01000101.xml

| 25.9.2015 | EN | Official Journal of the European Union | C 318/1 |
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25.9.2015

EN

Official Journal of the European Union

C 318/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2015 to 31 August 2015

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

1

(2015/C 318/01)

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

Issuing of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 14.8.2015 | Odomzo | sonidegib | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1030 | Capsule, hard | L01XX48 | 18.8.2015 |
| 14.8.2015 | Unituxin | dinutuximab | United Therapeutics Europe Ltd
  Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom | EU/1/15/1022 | Concentrate for solution for infusion | L01XC16 | 18.8.2015 |
| 20.8.2015 | Aripiprazole Sandoz | Aripiprazole | Sandoz GmbH
  Biochemiestrasse 10, A-6250 Kundl, Österreich | EU/1/15/1029 | Tablet | N05AX12 | 24.8.2015 |
| 20.8.2015 | Duloxetine Zentiva | duloxetine | Zentiva, k.s.
  U Kabelovny 130, 102 37 Praha 10, Česká republika | EU/1/15/1028 | Gastro-resistant capsule, hard | N06AX21 | 25.8.2015 |
| 20.8.2015 | Respreeza | human alpha1-proteinase inhibitor | CSL Behring GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/15/1006 | Powder and solvent for solution for infusion | B02AB02 | 25.8.2015 |
| 28.8.2015 | Docetaxel Hospira UK Limited | docetaxel | Hospira UK Limited
  Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom | EU/1/15/1017 | Concentrate for solution for infusion | L01CD02 | 1.9.2015 |
| 28.8.2015 | Farydak | panobinostat | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/1023 | Capsule, hard | L01XX42 | 1.9.2015 |
| 28.8.2015 | Kanuma | sebelipase alfa | Synageva BioPharma Ltd
  1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom | EU/1/15/1033 | Concentrate and solvent for solution for infusion | Pending | 1.9.2015 |
| 28.8.2015 | Pregabalin Accord | pregabalin | Accord Healthcare Limited
  Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom | EU/1/15/1027 | Capsule, hard | N03AX16 | 1.9.2015 |
| 28.8.2015 | Strensiq | asfotase alfa | Alexion Europe SAS
  1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France | EU/1/15/1015 | Solution for injection | Pending | 1.9.2015 |

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

14.8.2015

Odomzo

sonidegib

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1030

Capsule, hard

L01XX48

18.8.2015

14.8.2015

Unituxin

dinutuximab

United Therapeutics Europe Ltd

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

EU/1/15/1022

Concentrate for solution for infusion

L01XC16

18.8.2015

20.8.2015

Aripiprazole Sandoz

Aripiprazole

Sandoz GmbH

Biochemiestrasse 10, A-6250 Kundl, Österreich

EU/1/15/1029

Tablet

N05AX12

24.8.2015

20.8.2015

Duloxetine Zentiva

duloxetine

Zentiva, k.s.

U Kabelovny 130, 102 37 Praha 10, Česká republika

EU/1/15/1028

Gastro-resistant capsule, hard

N06AX21

25.8.2015

20.8.2015

Respreeza

human alpha1-proteinase inhibitor

CSL Behring GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/15/1006

Powder and solvent for solution for infusion

B02AB02

25.8.2015

28.8.2015

Docetaxel Hospira UK Limited

docetaxel

Hospira UK Limited

Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom

EU/1/15/1017

Concentrate for solution for infusion

L01CD02

1.9.2015

28.8.2015

Farydak

panobinostat

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/1023

Capsule, hard

L01XX42

1.9.2015

28.8.2015

Kanuma

sebelipase alfa

Synageva BioPharma Ltd

1A Local Board Road, Watford, Hertfordshire WD 17 2JP, United Kingdom

EU/1/15/1033

Concentrate and solvent for solution for infusion

Pending

1.9.2015

28.8.2015

Pregabalin Accord

pregabalin

Accord Healthcare Limited

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

EU/1/15/1027

Capsule, hard

N03AX16

1.9.2015

28.8.2015

Strensiq

asfotase alfa

Alexion Europe SAS

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

EU/1/15/1015

Solution for injection

Pending

1.9.2015

—   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 |
| --- | --- | --- | --- | --- |
| 6.8.2015 | Aerius | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/160 | 10.8.2015 |
| 6.8.2015 | Azomyr | Merck Sharp & Dohme Limited
  Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom | EU/1/00/157 | 10.8.2015 |
| 6.8.2015 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507 | 10.8.2015 |
| 6.8.2015 | Intanza | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/08/505 | 10.8.2015 |
| 12.8.2015 | Cyanokit | SERB S.A.
  Avenue Louise 480, 1050 Brussels, Belgique | EU/1/07/420 | 14.8.2015 |
| 12.8.2015 | Retacrit | Hospira UK Limited
  Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom | EU/1/07/431 | 14.8.2015 |
| 14.8.2015 | Cialis | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/02/237 | 18.8.2015 |
| 14.8.2015 | Komboglyze | AstraZeneca AB
  SE-151 85 Södertälje, Sverige | EU/1/11/731 | 18.8.2015 |
| 14.8.2015 | Norvir | AbbVie Ltd
  Maidenhead, SL6 4UB, United Kingdom | EU/1/96/016 | 18.8.2015 |
| 20.8.2015 | Adcirca | Eli Lilly Nederland B.V.
  Grootslag 1-5, NL-3991 RA Houten, Nederland | EU/1/08/476 | 24.8.2015 |
| 20.8.2015 | BeneFIX | Pfizer Limited
  Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom | EU/1/97/047 | 24.8.2015 |
| 20.8.2015 | Eliquis | Bristol-Myers Squibb/Pfizer EEIG
  Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom | EU/1/11/691 | 24.8.2015 |
| 20.8.2015 | Entyvio | Takeda Pharma A/S
  Dybendal Alle 10, 2630 Taastrup, Danmark | EU/1/14/923 | 24.8.2015 |
| 20.8.2015 | Eporatio | ratiopharm GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/573 | 24.8.2015 |
| 20.8.2015 | Fareston | Orion Corporation
  Orionintie 1, FI-02200 Espoo, Suomi | EU/1/96/004 | 24.8.2015 |
| 20.8.2015 | Infanrix hexa | GlaxoSmithKline Biologicals S.A.
  rue de l’Institut 89, 1330 Rixensart, Belgique | EU/1/00/152 | 1.9.2015 |
| 20.8.2015 | Invokana | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/13/884 | 24.8.2015 |
| 20.8.2015 | Kalydeco | Vertex Pharmaceuticals (Europe) Limited
  2 Kingdom Street, London W2 6BD, United Kingdom | EU/1/12/782 | 27.8.2015 |
| 20.8.2015 | Keppra | UCB Pharma S.A.
  Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België | EU/1/00/146 | 24.8.2015 |
| 20.8.2015 | OLYSIO | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/924 | 24.8.2015 |
| 20.8.2015 | Qutenza | Astellas Pharma Europe B.V.
  Sylviusweg 62, NL-2333 BE Leiden, Nederland | EU/1/09/524 | 24.8.2015 |
| 20.8.2015 | Stayveer | Marklas Nederland B.V.
  Beneluxlaan 2b, NL-3446 GR Woerden, Nederland | EU/1/13/832 | 24.8.2015 |
| 20.8.2015 | Tracleer | Actelion Registration Ltd
  Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom | EU/1/02/220 | 24.8.2015 |
| 20.8.2015 | Twynsta | Boehringer Ingelheim International GmbH
  Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland | EU/1/10/648 | 24.8.2015 |
| 20.8.2015 | Vokanamet | Janssen-Cilag International NV
  Turnhoutseweg 30, B-2340 Beerse, België | EU/1/14/918 | 24.8.2015 |
| 25.8.2015 | Adasuve | Ferrer Internacional S.A.
  Gran Via Carlos III, 94 08028 Barcelona Spain | EU/1/13/823 | 27.8.2015 |
| 25.8.2015 | Biopoin | Teva GmbH
  Graf-Arco-Straße 3, D-89079 Ulm, Deutschland | EU/1/09/565 | 27.8.2015 |
| 25.8.2015 | IDflu | Sanofi Pasteur SA
  2 avenue Pont Pasteur, F-69007 Lyon, France | EU/1/08/507 | 27.8.2015 |
| 25.8.2015 | Intanza | Sanofi Pasteur MSD SNC
  162 avenue Jean Jaurès, 69007 Lyon, France | EU/1/08/505 | 27.8.2015 |
| 25.8.2015 | Mekinist | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/14/931 | 27.8.2015 |
| 25.8.2015 | Optaflu | Novartis Influenza Vaccines Marburg GmbH
  Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland | EU/1/07/394 | 27.8.2015 |
| 25.8.2015 | Revolade | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/10/612 | 27.8.2015 |
| 25.8.2015 | Tafinlar | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/13/865 | 27.8.2015 |
| 25.8.2015 | Temozolomide Teva | Teva B.V.
  Swensweg 5, 2031 GA Haarlem, Nederland | EU/1/09/606 | 27.8.2015 |
| 25.8.2015 | Zykadia | Novartis Europharm Limited
  Frimley Business Park, Camberley GU16 7SR, United Kingdom | EU/1/15/999 | 27.8.2015 |
| 28.8.2015 | Fluenz Tetra | MedImmune, LLC
  Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland | EU/1/13/887 | 1.9.2015 |

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

6.8.2015

Aerius

Merck Sharp & Dohme Limited

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

EU/1/00/160

10.8.2015

6.8.2015

Azomyr

Merck Sharp & Dohme Limited

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

EU/1/00/157

10.8.2015

6.8.2015

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

10.8.2015

6.8.2015

Intanza

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/08/505

10.8.2015

12.8.2015

Cyanokit

SERB S.A.

Avenue Louise 480, 1050 Brussels, Belgique

EU/1/07/420

14.8.2015

12.8.2015

Retacrit

Hospira UK Limited

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

EU/1/07/431

14.8.2015

14.8.2015

Cialis

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/02/237

18.8.2015

14.8.2015

Komboglyze

AstraZeneca AB

SE-151 85 Södertälje, Sverige

EU/1/11/731

18.8.2015

14.8.2015

Norvir

AbbVie Ltd

Maidenhead, SL6 4UB, United Kingdom

EU/1/96/016

18.8.2015

20.8.2015

Adcirca

Eli Lilly Nederland B.V.

Grootslag 1-5, NL-3991 RA Houten, Nederland

EU/1/08/476

24.8.2015

20.8.2015

BeneFIX

Pfizer Limited

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

EU/1/97/047

24.8.2015

20.8.2015

Eliquis

Bristol-Myers Squibb/Pfizer EEIG

Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom

EU/1/11/691

24.8.2015

20.8.2015

Entyvio

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Danmark

EU/1/14/923

24.8.2015

20.8.2015

Eporatio

ratiopharm GmbH

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

EU/1/09/573

24.8.2015

20.8.2015

Fareston

Orion Corporation

Orionintie 1, FI-02200 Espoo, Suomi

EU/1/96/004

24.8.2015

20.8.2015

Infanrix hexa

GlaxoSmithKline Biologicals S.A.

rue de l’Institut 89, 1330 Rixensart, Belgique

EU/1/00/152

1.9.2015

20.8.2015

Invokana

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/13/884

24.8.2015

20.8.2015

Kalydeco

Vertex Pharmaceuticals (Europe) Limited

2 Kingdom Street, London W2 6BD, United Kingdom

EU/1/12/782

27.8.2015

20.8.2015

Keppra

UCB Pharma S.A.

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

EU/1/00/146

24.8.2015

20.8.2015

OLYSIO

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/924

24.8.2015

20.8.2015

Qutenza

Astellas Pharma Europe B.V.

Sylviusweg 62, NL-2333 BE Leiden, Nederland

EU/1/09/524

24.8.2015

20.8.2015

Stayveer

Marklas Nederland B.V.

Beneluxlaan 2b, NL-3446 GR Woerden, Nederland

EU/1/13/832

24.8.2015

20.8.2015

Tracleer

Actelion Registration Ltd

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

EU/1/02/220

24.8.2015

20.8.2015

Twynsta

Boehringer Ingelheim International GmbH

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

EU/1/10/648

24.8.2015

20.8.2015

Vokanamet

Janssen-Cilag International NV

Turnhoutseweg 30, B-2340 Beerse, België

EU/1/14/918

24.8.2015

25.8.2015

Adasuve

Ferrer Internacional S.A.

Gran Via Carlos III, 94 08028 Barcelona Spain

EU/1/13/823

27.8.2015

25.8.2015

Biopoin

Teva GmbH

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

EU/1/09/565

27.8.2015

25.8.2015

IDflu

Sanofi Pasteur SA

2 avenue Pont Pasteur, F-69007 Lyon, France

EU/1/08/507

27.8.2015

25.8.2015

Intanza

Sanofi Pasteur MSD SNC

162 avenue Jean Jaurès, 69007 Lyon, France

EU/1/08/505

27.8.2015

25.8.2015

Mekinist

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/14/931

27.8.2015

25.8.2015

Optaflu

Novartis Influenza Vaccines Marburg GmbH

Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland

EU/1/07/394

27.8.2015

25.8.2015

Revolade

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/10/612

27.8.2015

25.8.2015

Tafinlar

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/13/865

27.8.2015

25.8.2015

Temozolomide Teva

Teva B.V.

Swensweg 5, 2031 GA Haarlem, Nederland

EU/1/09/606

27.8.2015

25.8.2015

Zykadia

Novartis Europharm Limited

Frimley Business Park, Camberley GU16 7SR, United Kingdom

EU/1/15/999

27.8.2015

28.8.2015

Fluenz Tetra

MedImmune, LLC

Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland

EU/1/13/887

1.9.2015

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted

Issuing of a marketing authorisation

Accepted

| Date of the decision | Name of the medicinal product | INN (International Non-Proprietary Name) | Holder of the marketing authorisation | Number of the entry in the Community Register | Pharmaceutical form | ATC code (Anatomical Therapeutic Chemical Code) | Date of notification |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 28.8.2015 | Porcilis PCV ID | Porcine circovirus type 2 ORF2 subunit antigen | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/15/187 | Emulsion for injection | QI09AA07 | 1.9.2015 |

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

28.8.2015

Porcilis PCV ID

Porcine circovirus type 2 ORF2 subunit antigen

Intervet International B.V.

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

EU/2/15/187

Emulsion for injection

QI09AA07

1.9.2015

—   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 |
| --- | --- | --- | --- | --- |
| 6.8.2015 | Advocate | Bayer Animal Health GmbH
  D-51368 Leverkusen, Deutschland | EU/2/03/039 | 10.8.2015 |
| 20.8.2015 | Eurican Herpes 205 | Merial
  29 avenue Tony Garnier, F-69007 Lyon, France | EU/2/01/029 | 24.8.2015 |
| 28.8.2015 | Equilis StrepE | Intervet International B.V.
  Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland | EU/2/04/043 | 1.9.2015 |
| 28.8.2015 | Fevaxyn Pentofel | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/96/002 | 1.9.2015 |

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

6.8.2015

Advocate

Bayer Animal Health GmbH

D-51368 Leverkusen, Deutschland

EU/2/03/039

10.8.2015

20.8.2015

Eurican Herpes 205

Merial

29 avenue Tony Garnier, F-69007 Lyon, France

EU/2/01/029

24.8.2015

28.8.2015

Equilis StrepE

Intervet International B.V.

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

EU/2/04/043

1.9.2015

28.8.2015

Fevaxyn Pentofel

Zoetis Belgium S.A.

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

EU/2/96/002

1.9.2015

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 |
| --- |
| 7, Westferry Circus, Canary Wharf |
| UK — LONDON E14 4H |

The European Medicines Agency

7, Westferry Circus, Canary Wharf

UK — LONDON E14 4H

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

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