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Withdrawn
This medicine is now withdrawn from use in the European Union.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

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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

  • Angiotensin II antagonists, plain
  • Angiotensin II antagonists, 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

Related content

How useful was this page?

Add your rating