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EMA Product

Copalia HCT

Product approved by European Medicines Agency (EU)

Basic Information

Copalia HCT

Regulatory Information

EMEA/H/C/001159

Authorised

November 3, 2009

27

November 27, 2024

Company Information

Ireland

Vista Building Elm Park Merrion Road Dublin 4

NOVARTIS EUROPHARM LIMITED

Active Ingredients

Active Substances Detail

amlodipinevalsartanhydrochlorothiazide

Detailed Information

Therapeutic Indication

### 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.

Overview Summary

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).

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