Rasilez HCT


aliskiren / hydrochlorothiazide

This medicine is authorised for use in the European Union.


Rasilez HCT is a medicine used to treat essential hypertension (high blood pressure) in adults. ‘Essential’ means that no specific cause for the hypertension can be found.

Rasilez HCT is used in patients whose blood pressure is not adequately controlled by aliskiren or hydrochlorothiazide taken alone. It can also be used in patients whose blood pressure is adequately controlled with aliskiren and hydrochlorothiazide taken as separate tablets, to replace the same doses of the two active substances.

The medicine contains the active substances aliskiren and hydrochlorothiazide.

This EPAR was last updated on 26/08/2020

Authorisation details

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

Product information

22/07/2020 Rasilez HCT - EMEA/H/C/000964 - IB/0095


  • 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

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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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