Imprida

Withdrawn

This medicine's authorisation has been withdrawn

amlodipine / valsartan

Overview

On 3 April 2017, the European Commission withdrew the marketing authorisation for Imprida (amlodipine / valsartan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Novartis Europharm Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Imprida was granted marketing authorisation in the EU on 17 January 2007 for treatment of essential hypertension. It was then granted unlimited validity in 2011. Imprida is a medicine that contains two active substances, amlodipine and valsartan. There are other medicinal products marketed in the EU that contain this combination of substances as well as products containing amlodipine or valsartan alone. 

The European Public Assessment Report (EPAR) for Imprida is updated accordingly to reflect the fact that the marketing authorisation is no longer valid

Imprida : EPAR - Summary for the public

Product information

Imprida : EPAR - Product Information

Imprida : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Imprida
• 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

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Imprida is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.

Authorisation details

• EMA product number:
  EMEA/H/C/000775
• Marketing authorisation holder:
  Novartis Europharm Ltd

  Frimley Business Park; Camberley GU16 7SR; United Kingdom

• Marketing authorisation issued:
  17/01/2007
• Withdrawal of marketing authorisation:
  03/04/2017
• Revision:
  20

Assessment history

Changes since initial authorisation of medicine

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

Imprida-H-C-775-A31-0069 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommenda...

Imprida-H-C-775-A31-0069 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

Imprida-H-C-775-WS-0360 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/356249/2013

CHMP post-authorisation summary of positive opinion for Imprida

Adopted Reference Number: EMA/CHMP/397194/2013

Imprida-H-C-775-WS-0100-G : EPAR - Assessment Report - Variation

Adopted

Initial marketing authorisation documents

Imprida : EPAR - Procedural steps taken before authorisation

Imprida : EPAR - Scientific Discussion