Rasilez HCT

Withdrawn

This medicine's authorisation has been withdrawn

aliskiren / hydrochlorothiazide

Overview

On 20 December 2021, the European Commission withdrew the marketing authorisation for Rasilez HCT (aliskiren / hydrochlorothiazide) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Noden Pharma DAC, which notified the European Commission of its decision to permanently discontinue the marketing of the product in the EU for commercial reasons. 

Rasilez HCT was granted marketing authorisation in the EU on 16 January 2009 for the treatment of essential hypertension. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2013. It was then granted unlimited validity in 2018. The product had not been marketed in the EU since 16 January 2009. 

The European Public Assessment Report (EPAR) for Rasilez HCT is updated to indicate that the marketing authorisation is no longer valid.

Rasilez HCT : EPAR - Medicine overview

Product information

Rasilez HCT : EPAR - Product Information

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

Adopted Reference Number: EMA/PRAC/294920/2014

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

Adopted Reference Number: EMA/CHMP/479605/2012

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

Adopted Reference Number: EMA/391210/2012

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

Adopted Reference 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