Pharmaceuticals - Community Register

  

Community register of veterinary medicinal products


AUTHORISED  

Product information

Invented name: PRILACTONE   
Auth. number : EU/2/07/074
Active substance : Spironolactone
ATC: Anatomical main group: QC - Cardiovascular system
Therapeutic subgroup: QC03 - Diuretics
Pharmacological subgroup: QC03D - Potassium-sparing agents
Chemical subgroup: QC03DA - Aldosterone antagonists
Chemical substance: QC03DA01 - Spironolactone
(See WHO ATCvet Index)
Indication: 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.
Marketing Authorisation Holder: CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, 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
22/06/2007 Centralised - Authorisation EMEA/V/C/105 (2007)3109 of 20/06/2007
07/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/V/C/105/IB/1
01/09/2008 Corrigendum (2007)3109 corr of 28/08/2008
13/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/105/IA/3
23/07/2009 Centralised - Variation EMEA/V/C/105/II/2 (2009)5904 of 20/07/2009
17/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/V/C/105/IA/5
26/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/V/C/105/IB/6
25/05/2012 Centralised - Renewal EMEA/V/C/105/R/7 (2012)3459 of 22/05/2012
07/09/2012 Centralised - Variation EMEA/V/C/105/IA/10/G
Updated with Decision(2012)8003 of 31/10/2012
06/11/2012 Centralised - Variation EMEA/V/C/105/II/8 (2012)8003 of 31/10/2012