Rasilez HCT

RSS

aliskiren / hydrochlorothiazide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Rasilez HCT has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 20/05/2022

Authorisation details

Product details
Name
Rasilez HCT
Agency product number
EMEA/H/C/000964
Active substance
  • aliskiren
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • aliskiren
  • hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA52
Publication details
Marketing-authorisation holder
Noden Pharma DAC
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
16/01/2009
Contact address
D'Olier Chambers
16A D'Olier Street
Dublin 2
Ireland

Product information

20/12/2021 Rasilez HCT - EMEA/H/C/000964 -

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 in adults.

Rasilez HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.

Rasilez HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.

Assessment history

Changes since initial authorisation of medicine

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