Imprida HCT

Lapsed

This medicine's authorisation has lapsed

amlodipine / valsartan / hydrochlorothiazide

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.

 

Imprida HCT : EPAR - Summary for the public

Product information

Imprida HCT : EPAR - Product Information

Latest procedure affecting product information: WS/0250/G

20/10/2012

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).

Imprida HCT : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Imprida HCT
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001161
• Marketing authorisation holder:
  Novartis Europharm Ltd.

  Novartis Europharm Limited; Wimblehurst Road; Horsham; West Sussex, RH12 5AB; United Kingdom

• Marketing authorisation issued:
  15/10/2009
• Lapse of marketing authorisation:
  20/10/2012
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Imprida HCT : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Imprida HCT : EPAR - Public assessment report