Rasitrio
Withdrawn
This medicine's authorisation has been withdrawn
aliskiren / amlodipine / hydrochlorothiazide
MedicineHumanWithdrawn
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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The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.
Product information
Latest procedure affecting product information:IB/0015
03/10/2013
This medicine’s product information is available in all official EU languages.
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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).
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 systemTherapeutic 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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