- Application under evaluation
- CVMP opinion
- European Commission decision
Overview
The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.
Prilactone : EPAR - Medicine overview
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Product information
Spironolactone Ceva : EPAR - Product Information
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Spironolactone Ceva : EPAR - All Authorised presentations
English (EN) (395.25 KB - PDF)
български (BG) (299.51 KB - PDF)
español (ES) (219.22 KB - PDF)
čeština (CS) (262.67 KB - PDF)
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français (FR) (221.14 KB - PDF)
hrvatski (HR) (227.55 KB - PDF)
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italiano (IT) (191.92 KB - PDF)
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lietuvių kalba (LT) (210.34 KB - PDF)
magyar (HU) (210.45 KB - PDF)
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norsk (NO) (222.67 KB - PDF)
polski (PL) (245.92 KB - PDF)
português (PT) (231.37 KB - PDF)
română (RO) (434.62 KB - PDF)
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slovenščina (SL) (237.31 KB - PDF)
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svenska (SV) (218.51 KB - PDF)
Product details
- Name of medicine
- Spironolactone Ceva
- Active substance
- spironolactone
- International non-proprietary name (INN) or common name
- spironolactone
- Species
- Dogs
- Anatomical therapeutic chemical veterinary (ATCvet) code
- QC03DA01
Pharmacotherapeutic group
DiureticsTherapeutic 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.
Authorisation details
- EMA product number
- EMEA/V/C/000105
- Marketing authorisation holder
- Ceva Santé Animale
10 avenue de la Ballastière
33500 Libourne
France - Opinion adopted
- 17/04/2007
- Marketing authorisation issued
- 20/06/2007
- Revision
- 7
Assessment history
Spironolactone Ceva : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (254.31 KB - PDF)