Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products
AUTHORISED  

Product information
Invented name: Ypozane   
Auth. number : EU/2/06/068
Active substance : 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., 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
21/12/2016 Centralised - Variation EMEA/V/C/112/IG/724/2
Updated with Decision(2018)142 of 09/01/2018
11/01/2018 Centralised - Yearly update (2018)142 of 09/01/2018