Rasilamlo

Withdrawn

This medicine's authorisation has been withdrawn

aliskiren hemifumarate / amlodipine besilate

Overview

On 25 June 2015, the European Commission withdrew the marketing authorisation for Rasilamlo (aliskiren / amlodipine) 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. 

Rasilamlo was granted marketing authorisation in the EU on 14 April 2011 for treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone. The product had not been marketed in the EU since 2014. The European Public Assessment Report (EPAR) for Rasilamlo is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Rasilamlo : EPAR - Summary for the public

Product information

Rasilamlo : EPAR - Product Information

Rasilamlo : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rasilamlo
• Active substance:
  • aliskiren
  • amlodipine
• International non-proprietary name (INN) or common name:
  • aliskiren hemifumarate
  • amlodipine besilate
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09XA53

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.

Authorisation details

• EMA product number:
  EMEA/H/C/002073
• Marketing authorisation holder:
  Novartis Europharm Ltd

  Wimblehurst Road; Horsham; West Sussex; RH12 5AB; United Kingdom

• Marketing authorisation issued:
  14/04/2011
• Withdrawal of marketing authorisation:
  25/06/2015
• Revision:
  7

Assessment history

Changes since initial authorisation of medicine

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

Reference Number: EMA/992265/2011

Rasilamlo-H-C-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation

Reference Number: EMA/CHMP/333074/2015

Rasilamlo-H-C-2073-A31-84 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

Rasilamlo-H-C-2073-A31-84 : 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 recommen...

Rasilamlo-H-C-2073-PSUV-90 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/554133/2014

Rasilamlo H-C-2073-A20-16 : EPAR - Assessment Report - Variation

Reference Number: EMA/390880/2012

Rasilamlo-H-C-2073-WS-169 : EPAR - Assessment Report - Variation

Reference Number: EMA/CHMP/479606/2012

Initial marketing authorisation documents

Rasilamlo : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Rasilamlo

Adopted Reference Number: EMA/CHMP/124404/2011