Exforge HCT
amlodipine besilate / valsartan / hydrochlorothiazide
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Exforge 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 Exforge HCT.
Authorisation details
Product details | |
---|---|
Name |
Exforge HCT
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Agency product number |
EMEA/H/C/001068
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Hypertension
|
Anatomical therapeutic chemical (ATC) code |
C09DX01
|
Publication details | |
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Marketing-authorisation holder |
Novartis Europharm Limited
|
Revision |
17
|
Date of issue of marketing authorisation valid throughout the European Union |
15/10/2009
|
Contact address |
Product information
23/06/2020 Exforge HCT - EMEA/H/C/001068 - IG/1255
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
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