Rasilez HCT

Withdrawn

This medicine's authorisation has been withdrawn

aliskiren / hydrochlorothiazide

Overview

The marketing authorisation for Rasilez HCT has been withdrawn at the request of the marketing-authorisation holder.

Rasilez HCT : EPAR - Medicine overview

Product information

Rasilez HCT : EPAR - Product Information

Latest procedure affecting product information:

20/12/2021

This medicine’s product information is available in all official EU languages.
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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).

Rasilez HCT : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Rasilez HCT
• Active substance:
  • aliskiren
  • hydrochlorothiazide
• International non-proprietary name (INN) or common name:
  • aliskiren
  • hydrochlorothiazide
• Therapeutic area (MeSH):
  Hypertension
• Anatomical therapeutic chemical (ATC) code:
  C09XA52

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000964
• Marketing authorisation holder:
  Noden Pharma DAC

  D'Olier Chambers; 16A D'Olier Street; Dublin 2; Ireland

• Marketing authorisation issued:
  16/01/2009
• Revision:
  17

Assessment history

Changes since initial authorisation of medicine

Rasilez HCT : EPAR - Procedural steps taken and scientific information after authorisation

Rasilez-H-C-964-PSUSA-00000089-201409 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/333074/2015

Rasilez HCT-H-C-964-A31-0053 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recomm...

Rasilez HCT-H-C-964-PSUV-0060 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/554712/2014

Rasilez HCT-H-C-964-A31-0053 : EPAR - Assessment Report - Article 31

AdoptedReference Number: EMA/PRAC/294920/2014

Rasilez HCT-H-C-964-WS-0037 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479605/2012

Rasilez HCT-H-C-964-A20-0026 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/391210/2012

Rasilez-HCT-964-WS-0069 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/74385/2012

Initial marketing authorisation documents

Rasilez HCT : EPAR - Public assessment report

CHMP summary of positive opinion for Rasilez HCT

Reference Number: EMEA/CHMP/599453/2008