Cardalis

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benazepril hydrochloride / spironolactone

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR). Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.

This summary cannot replace a face-to-face discussion with your veterinarian. If you need more information about your animal’s medical condition or treatment, contact your veterinarian. If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 30/06/2017

Authorisation details

Product details
Name
Cardalis
Agency product number
EMEA/V/C/002524
Active substance
benazepril hydrochloride / spironolactone
International non-proprietary name (INN) or common name
benazepril hydrochloride / spironolactone
Species
Dogs
Anatomical therapeutic chemical veterinary (ATCvet) codes
QC09BA07
Publication details
Marketing-authorisation holder
Ceva Santé Animale
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
23/07/2012
Contact address
10 avenue de la Ballastière
33500 Libourne
France

Product information

08/06/2017 Cardalis - EMEA/V/C/002524 - R/0009

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CARDIOVASCULAR SYSTEM

Therapeutic indication

For the treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support as appropriate).

Assessment history

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