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 28/10/2021

Authorisation details

Product details
Name
Exforge
Agency product number
EMEA/H/C/000716
Active substance
  • valsartan
  • amlodipine (as amlodipine besilate)
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
30
Date of issue of marketing authorisation valid throughout the European Union
16/01/2007
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

05/10/2021 Exforge - EMEA/H/C/000716 - IG/1438/G

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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

Related content

How useful was this page?

Add your rating
Average
1 rating
1 rating