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Community Register of medicinal products
Community register of veterinary medicinal products |
AUTHORISED |
Product information |
| Invented name: | PRILACTONE
|
| Auth. number : | EU/2/07/074 |
| INN : | Spironolactone |
| ATC: | QC - Cardiovascular system QC03 - Diuretics QC03D - Potassium-sparing agents QC03DA - Aldosterone antagonists 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
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 continues to be available in the Community Register. |
European Commission procedures
| 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 | EMEA/V/C/105/IB/1 | ||||
| 01/09/2008 | Corrigendum | - | (2007)3109 corr of 28/08/2008 | |||
| 13/07/2009 | Centralised - Variation | 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 | EMEA/V/C/105/IA/5 | ||||
| 26/11/2010 | Centralised - Variation | 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 |