# C_2014337EN.01000101.xml

| 26.9.2014 | EN | Official Journal of the European Union | C 337/1 |
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26.9.2014

EN

Official Journal of the European Union

C 337/1

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Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014

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

1

2014/C 337/01

—   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 |
| --- | --- | --- | --- | --- |
| 11.7.2014 | Aclasta | Novartis Europharm Limited
  Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom | EU/1/05/308 | 20.8.2014 |

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

11.7.2014

Aclasta

Novartis Europharm Limited

Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom

EU/1/05/308

20.8.2014

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

Withdrawal of a marketing authorisation

| Date of the decision | Name of the medicinal product | Holder of the marketing authorisation | Number of the entry in the Community Register | Date of notification |
| --- | --- | --- | --- | --- |
| 18.7.2014 | Revasc | Canyon Pharmaceuticals Ltd
  7th Floor, 52-54 Gracechurch Street, London EC3V 0EH, United Kingdom | EU/1/97/043 | 22.8.2014 |

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

18.7.2014

Revasc

Canyon Pharmaceuticals Ltd

7th Floor, 52-54 Gracechurch Street, London EC3V 0EH, United Kingdom

EU/1/97/043

22.8.2014

—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): Accepted

Issuing of a marketing authorisation

2

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 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 31.7.2014 | Versican Plus Pi/L4R | Canine parainfluenza type 2 virus
  Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
  Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
  Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
  Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088
  Inactivated rabies virus, strain SAD Vnukovo-32 | Zoetis Belgium S.A.
  Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique | EU/2/14/173 | Lyophilisate and solvent for suspension for injection | QI07AJ | 4.8.2014 |

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

31.7.2014

Versican Plus Pi/L4R

Canine parainfluenza type 2 virus

Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089

Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090

Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091

Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088

Inactivated rabies virus, strain SAD Vnukovo-32

Zoetis Belgium S.A.

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

EU/2/14/173

Lyophilisate and solvent for suspension for injection

QI07AJ

4.8.2014

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

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(1)  OJ L 136, 30.4.04, p. 1.

1

(2)  OJ L 136, 30.4.04, p. 1.

2

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