Copalia HCT
amlodipine / valsartan / hydrochlorothiazide
Table of contents
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).
Authorisation details
Product details | |
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Name |
Copalia HCT
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Agency product number |
EMEA/H/C/001159
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Active substance |
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
Hypertension
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Anatomical therapeutic chemical (ATC) code |
C09DX01
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Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
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Revision |
17
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Date of issue of marketing authorisation valid throughout the European Union |
03/11/2009
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Contact address |
Product information
20/10/2020 Copalia HCT - EMEA/H/C/001159 - IB/0087/G
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
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Agents acting on the renin-angiotensin system
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Angiotensin II antagonists and calcium channel blockers
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Angiotensin II antagonists, 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
News
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28/06/2013
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17/05/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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20/10/2011