Dafiro HCT

RSS

amlodipine besylate / 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 04/07/2018

Authorisation details

Product details
Name
Dafiro HCT
Agency product number
EMEA/H/C/001160
Active substance
  • Amlodipine besylate
  • valsartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
amlodipine besylate / valsartan / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DX01
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
04/11/2009
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

25/06/2018 Dafiro HCT - EMEA/H/C/001160 - T/0068

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

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

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