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Pharmaceuticals - Community Register
Community register of veterinary medicinal products |
AUTHORISED |
Product information |
Invented name: | Ypozane
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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 procedures |
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 |