Rasilez HCT

RSS

aliskiren / hydrochlorothiazide

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

Overview

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 21/01/2019

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
16
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

11/12/2018 Rasilez HCT - EMEA/H/C/000964 - IAIN/0091

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

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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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