Rasilez

RSS

aliskiren

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Rasilez. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rasilez.

This EPAR was last updated on 21/01/2019

Authorisation details

Product details
Name
Rasilez
Agency product number
EMEA/H/C/000780
Active substance
aliskiren
International non-proprietary name (INN) or common name
aliskiren
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA02
Publication details
Marketing-authorisation holder
Noden Pharma DAC
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
22/08/2007
Contact address
D'Olier Chambers
16A D'Olier Street
Dublin 2
Ireland

Product information

18/10/2018 Rasilez - EMEA/H/C/000780 - WS/1371

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

Treatment of essential hypertension.

Assessment history

Changes since initial authorisation of medicine

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