Riprazo HCT

Withdrawn

This medicine's authorisation has been withdrawn

aliskiren / hydrochlorothiazide

Overview

The marketing authorisation for Riprazo HCT has been withdrawn at the request of the marketing-authorisation holder.

Riprazo HCT : EPAR - Summary for the public

Reference Number: EMA/106444/2011

Product information

Riprazo HCT : EPAR - Product Information

30/08/2012

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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).

Riprazo HCT : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Riprazo 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.

Riprazo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.

Rirpozo 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/002420
• Marketing authorisation holder:
  Novartis Europharm Ltd.

  Wimblehurst Road; Horsham; West Sussex; RH12 5AB; United Kingdom

• Marketing authorisation issued:
  13/04/2011

Assessment history

Changes since initial authorisation of medicine

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

Riprazo HCT-H-C-2420-A20-15 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/391001/2012

Riprazo HCT-H-C-2420-WS-169 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479606/2012

Initial marketing authorisation documents

Riprazo HCT : EPAR - Public assessment report

AdoptedReference Number: EMA/745107/2011

CHMP summary of positive opinion for Riprazo HCT

AdoptedReference Number: EMA/35671/2011