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 09/02/2022

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
25
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

28/01/2022 Rasilez - EMEA/H/C/000780 - IA/0128/G

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

Treatment of essential hypertension.

Assessment history

Changes since initial authorisation of medicine

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