Rasilamlo

Withdrawn

This medicine's authorisation has been withdrawn

aliskiren hemifumarate / amlodipine besilate

Overview

The marketing authorisation for Rasilamlo has been withdrawn at the request of the marketing-authorisation holder.

Rasilamlo : EPAR - Summary for the public

Product information

Rasilamlo : EPAR - Product Information

25/06/2015

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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).

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
• 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

AdoptedReference 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

AdoptedReference Number: EMA/CHMP/124404/2011