Copalia HCT

RSS

amlodipine / 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) for Copalia HCT. 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 Copalia HCT.

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 11/02/2019

Authorisation details

Product details
Name
Copalia HCT
Agency product number
EMEA/H/C/001159
Active substance
  • amlodipine
  • valsartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
amlodipine / 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
03/11/2009
Contact address

Elm Park, Merrion Road
Dublin 4
Ireland

Product information

11/12/2018 Copalia HCT - EMEA/H/C/001159 - IG/1017

Contents

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

  • Angiotensin II antagonists
  • other combinations

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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