- 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The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.
Rasitrio : EPAR - Summary for the public
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Product information
Rasitrio : EPAR - Product Information
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slovenščina (SL) (8.29 MB - PDF)
Suomi (FI) (4.65 MB - PDF)
svenska (SV) (4.53 MB - PDF)
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).
Rasitrio : EPAR - All Authorised presentations
English (EN) (492.71 KB - PDF)
български (BG) (608.24 KB - PDF)
español (ES) (497.14 KB - PDF)
čeština (CS) (1 MB - PDF)
dansk (DA) (496.37 KB - PDF)
Deutsch (DE) (497.7 KB - PDF)
eesti keel (ET) (496.69 KB - PDF)
ελληνικά (EL) (610.98 KB - PDF)
français (FR) (500.89 KB - PDF)
íslenska (IS) (493.62 KB - PDF)
italiano (IT) (497.22 KB - PDF)
latviešu valoda (LV) (580.69 KB - PDF)
lietuvių kalba (LT) (527.73 KB - PDF)
magyar (HU) (590.84 KB - PDF)
Malti (MT) (562.9 KB - PDF)
Nederlands (NL) (496.21 KB - PDF)
norsk (NO) (490.07 KB - PDF)
polski (PL) (1.02 MB - PDF)
português (PT) (497.58 KB - PDF)
română (RO) (527.11 KB - PDF)
slovenčina (SK) (578.02 KB - PDF)
Suomi (FI) (496.74 KB - PDF)
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.
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
Rasitrio : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (972.03 KB - PDF)
Rasitrio-H-C-2017-A20-1 : EPAR - Assessment Report - Article 20
English (EN) (908.97 KB - PDF)
News on Rasitrio
More information on Rasitrio
Questions and answers on the review aliskiren-containing medicines
English (EN) (60.98 KB - PDF)
Questions and answers on ongoing review of aliskiren-containing medicines
English (EN) (65.3 KB - PDF)