Rasitrio

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Withdrawn

This medicine's authorisation has been withdrawn

aliskiren / amlodipine / hydrochlorothiazide
MedicineHumanWithdrawn

Swedish is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.

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Product information

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Latest procedure affecting product information:IB/0015
03/10/2013
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

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Product details

Name of medicine
Rasitrio
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

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.

Authorisation details

EMA product number
EMEA/H/C/002017
Marketing authorisation holder
Novartis Europharm Ltd.

Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Marketing authorisation issued
22/11/2011
Revision
1

Assessment history

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