Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: Ypozane   
Auth. number : EU/2/06/068
INN : Osaterone acetate
ATC: Anatomical main group: QG - Genito-urinary system and sex hormones
Therapeutic subgroup: QG04 - Urologicals
Pharmacological subgroup: QG04C - Drugs used in benign prostatic hypertrophy
Chemical subgroup: QG04CX - Other estrogens
Chemical substance: QG04CX - Other estrogens
(See WHO ATCvet Index)
Indication: Treatment of benign prostatic hypertrophy (BPH) in male dogs
Marketing Authorisation Holder: VIRBAC S.A.
1ère Avenue - 2065 m - L.I.D., F-06516 Carros CEDEX, France

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
15/01/2007 Centralised - Authorisation EMEA/V/C/112 (2007)117 of 11/01/2007
21/12/2011 Centralised - Renewal EMEA/V/C/112/R/1 (2011)9952 of 19/12/2011