Spironolactone Ceva

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spironolactone

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.

This EPAR was last updated on 10/05/2021

Authorisation details

Product details
Name
Spironolactone Ceva
Agency product number
EMEA/V/C/000105
Active substance
spironolactone
International non-proprietary name (INN) or common name
spironolactone
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QC03DA01
Publication details
Marketing-authorisation holder
Ceva Santé Animale
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
20/06/2007
Contact address
10 avenue de la Ballastière
33500 Libourne
France

Product information

31/10/2012 Spironolactone Ceva - EMEA/V/C/000105 - IAIN/0014

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Diuretics

Therapeutic 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.

Assessment history

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