amlodipine / valsartan
This is a summary of the European public assessment report (EPAR) for Dafiro. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Dafiro.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Dafiro : EPAR - Summary for the public (PDF/75.1 KB)
First published: 05/05/2009
Last updated: 10/07/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
26/04/2021 Dafiro - EMEA/H/C/000776 - IG/1383/G
- 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.
Agents acting on the renin-angiotensin system
Treatment of essential hypertension.
Dafiro is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
European Medicines Agency concludes that benefit-risk balance of angiotensin-II-receptor antagonists remains positive20/10/2011
European Medicines Agency recommendation on use of angiotensin-II-receptor antagonists during pregnancy24/04/2008