Rasilamlo

RSS

aliskiren / amlodipine

Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Rasilamlo has been withdrawn at the request of the marketing-authorisation holder.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 / amlodipine
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 -

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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