Dafiro HCT

RSS

amlodipine besilate / valsartan / hydrochlorothiazide

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

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 for the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 04/04/2022

Authorisation details

Product details
Name
Dafiro HCT
Agency product number
EMEA/H/C/001160
Active substance
  • valsartan
  • hydrochlorothiazide
  • Amlodipine besilate
International non-proprietary name (INN) or common name
  • amlodipine besilate
  • valsartan
  • hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DX01
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
23
Date of issue of marketing authorisation valid throughout the European Union
03/11/2009
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

31/03/2022 Dafiro HCT - EMEA/H/C/001160 - WS2237

Product information documents contain:

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

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating