aliskiren / amlodipine / hydrochlorothiazide
The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.
Rasitrio : EPAR - Summary for the public (PDF/546.37 KB)
First published: 19/12/2011
Last updated: 20/09/2012
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Ltd.
|Date of issue of marketing authorisation valid throughout the European Union||
03/10/2013 Rasitrio - EMEA/H/C/002017 - IB/0015
- 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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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.