Exforge

RSS

amlodipine / valsartan

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Exforge. 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.

This EPAR was last updated on 05/07/2018

Authorisation details

Product details
Name
Exforge
Agency product number
EMEA/H/C/000716
Active substance
  • amlodipine (as besylate)
  • valsartan
International non-proprietary name (INN) or common name
amlodipine / valsartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DB01
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
17/01/2007
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

25/06/2018 Exforge - EMEA/H/C/000716 - T/0096

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.

Exforge is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Assessment history

Changes since initial authorisation of medicine

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