aliskiren / hydrochlorothiazide
The marketing authorisation for Rasilez HCT has been withdrawn at the request of the marketing-authorisation holder.
Rasilez HCT : EPAR - Medicine overview (PDF/696.64 KB)
First published: 09/02/2009
Last updated: 20/05/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Noden Pharma DAC
|Date of issue of marketing authorisation valid throughout the European Union||
16A D'Olier Street
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.
Agents acting on the renin-angiotensin system
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.