Imprida HCT

Lapsed

This medicine's authorisation has lapsed

amlodipine / valsartan / hydrochlorothiazide

Overview

On 15 October 2009, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Imprida HCT (amlodipine/valsartan/hydrochlorothiazide), indicated for the treatment of essential hypertension. The marketing authorisation holder was notified on the 19 October 2009. 

Imprida HCT (amlodipine/valsartan/hydrochlorothiazide) had not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation. 

Because of this, from 20 October 2012, the marketing authorisation for Imprida HCT is no longer valid. 

Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Imprida HCT is updated to reflect that the marketing authorisation is no longer valid.

Imprida HCT : EPAR - Summary for the public

Product information

Imprida HCT : EPAR - Product Information

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