The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.
Prilactone : EPAR - Medicine overview (PDF/312.06 KB)
First published: 18/07/2007
Last updated: 24/02/2021
|Agency product number||
|International non-proprietary name (INN) or common name||
|Anatomical therapeutic chemical veterinary (ATCvet) codes||
Ceva Santé Animale
|Date of issue of marketing authorisation valid throughout the European Union||
10 avenue de la Ballastière
31/10/2012 Spironolactone Ceva - EMEA/V/C/000105 - IAIN/0014
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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For use in combination with standard therapy (including diuretic support, where necessary) for the treatment of congestive heart failure caused by valvular regurgitation in dogs.
Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 202117/05/2021