Rasilamlo

RSS

aliskiren hemifumarate / amlodipine besilate

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Rasilamlo has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 28/03/2017

Authorisation details

Product details
Name
Rasilamlo
Agency product number
EMEA/H/C/002073
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
Publication details
Marketing-authorisation holder
Novartis Europharm Ltd
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
14/04/2011
Contact address
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

25/06/2015 Rasilamlo - EMEA/H/C/002073 -

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Select ‘available languages’ to access the language you need.

 

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Changes since initial authorisation of medicine

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