Riprazo

Withdrawn

This medicine's authorisation has been withdrawn

aliskiren

Overview

On 22 August 2007, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Riprazo, (aliskiren), which had been approved for treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Riprazo was Novartis Europharm Ltd. 

On 24 January 2013, the European Commission issued a decision to withdraw the marketing authorisation for Riprazo, following its receipt of a letter dated 18 December 2012 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Riprazo was marketed in the following European countries: Spain (until 31 December 2012) and was not marketed in any other European country. 

Pursuant to this decision, the European public assessment report for Riprazo is updated to reflect that the marketing authorisation is no longer valid.

Riprazo : EPAR - Summary for the public

Product information

Riprazo : EPAR - Product Information

Riprazo : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Riprazo
• Active substance:
  aliskiren
• International non-proprietary name (INN) or common name:
  aliskiren
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09XA02

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Authorisation details

• EMA product number:
  EMEA/H/C/000853
• Marketing authorisation holder:
  Novartis Europharm Ltd.

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

• Marketing authorisation issued:
  22/08/2007
• Withdrawal of marketing authorisation:
  24/01/2013
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

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

Riprazo-H-C-853-A20-69 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/CHMP/391141/2012

Riprazo-H-C-853-WS-37 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/479605/2012

Riprazo-H-C-853-WS-169 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/479606/2012

Riprazo-H-C-853-WS-69 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/74385/2012

Initial marketing authorisation documents

Riprazo : EPAR - Scientific Discussion

Riprazo : EPAR - Procedural steps taken before authorisation