Rasitrio
aliskiren / amlodipine / hydrochlorothiazide
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.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 |
|
| 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 | |
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
CARDIOVASCULAR SYSTEM
Therapeutic indication
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.