Imprida

Withdrawn

This medicine's authorisation has been withdrawn

amlodipine / valsartan

Overview

The marketing authorisation for Imprida has been withdrawn at the request of the marketing authorisation holder.

Imprida : EPAR - Summary for the public

Product information

Imprida : EPAR - Product Information

Latest procedure affecting product information: WS/0709

03/04/2017

This medicine’s product information is available in all official EU languages.
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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 : 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
• 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

AdoptedReference Number: EMA/PRAC/294920/2014

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

AdoptedReference Number: EMA/CHMP/356249/2013

CHMP post-authorisation summary of positive opinion for Imprida

AdoptedReference 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