Rasitrio

RSS

aliskiren / amlodipine / hydrochlorothiazide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 03/10/2013

Authorisation details

Product details
Name
Rasitrio
Agency product number
EMEA/H/C/002017
Active substance
  • aliskiren
  • amlodipine
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
aliskiren / amlodipine / hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA54
Publication details
Marketing-authorisation holder
Novartis Europharm Ltd.
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
22/11/2011
Contact address
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

03/10/2013 Rasitrio - EMEA/H/C/002017 - IB/0015

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

CARDIOVASCULAR SYSTEM

Therapeutic indication

Rasitrio is indicated for the treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of aliskiren, amlodipine and hydrochlorothiazide given concurrently at the same dose level as in the combination.

Assessment history

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