Imprida HCT

RSS

amlodipine / valsartan / hydrochlorothiazide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Imprida HCT has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 22/10/2012

Authorisation details

Product details
Name
Imprida HCT
Agency product number
EMEA/H/C/001161
Active substance
  • amlodipine
  • valsartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
amlodipine / valsartan / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DX01
Publication details
Marketing-authorisation holder
Novartis Europharm Ltd.
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
15/10/2009
Contact address
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Product information

20/10/2012 Imprida HCT - EMEA/H/C/001161 - WS/0250/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

  • Angiotensin II antagonists
  • other 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

How useful was this page?

Add your rating