Spironolactone Ceva

Withdrawn

This medicine's authorisation has been withdrawn

spironolactone

Overview

The marketing authorisation for this product has been withdrawn due to the application of the sunset clause.

Prilactone : EPAR - Medicine overview

Product information

Spironolactone Ceva : EPAR - Product Information

Spironolactone Ceva : EPAR - All Authorised presentations

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

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.

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

Changes since initial authorisation of medicine

Spironolactone Ceva : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Prilactone : EPAR - Procedural steps taken before authorisation

Prilactone : EPAR - Scientific Discussion