Pharmaceuticals - Community Register


Community register of veterinary medicinal products


Product information

Invented name: Cardalis   
Auth. number : EU/2/12/142
Active substance : Benazepril hydrochloride, Spironolactone
ATC: Anatomical main group: QC - Cardiovascular system
Therapeutic subgroup: QC09 - Agents acting on the renin-angiotensin system
Pharmacological subgroup: QC09B - ACE inhibitors, combinations
Chemical subgroup: QC09BA - ACE inhibitors and diuretics
Chemical substance: QC09BA07 - benazepril and diuretics
(See WHO ATCvet Index)
Indication: Treatment of congestive heart failure caused by chronic degenerative valvular disease in dogs (with diuretic support as appropriate).
Marketing Authorisation Holder: Ceva Santé Animale
10 avenue de la Ballastière, 33500 Libourne, France
EPAR and active package presentations

Package presentations

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 is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/07/2012 Centralised - Authorisation EMEA/V/C/2524 (2012)5343 of 23/07/2012
11/04/2013 Centralised - Variation EMEA/V/C/2524/II/1
Updated with Decision(2014)3131 of 07/05/2014
12/05/2014 Centralised - Yearly update (2014)3131 of 07/05/2014
21/08/2014 Corrigendum (2014)3131 cor of 19/08/2014
07/12/2016 Centralised - Variation EMEA/V/C/2524/IB/7
Updated with Decision(2017) 4090 of 08/06/2017
12/06/2017 Centralised - Renewal EMEA/V/C/2524/R/9 (2017) 4090 of 08/06/2017
07/07/2017 Corrigendum (2017) 4090 of 08/06/2017
27/02/2018 Corrigendum (2017) 4090 of 08/06/2017