Rasitrio

RSS
Withdrawn

This medicine's authorisation has been withdrawn

aliskiren / amlodipine / hydrochlorothiazide
Medicine Human Withdrawn
  • 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The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.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

Reference Number: EMA/808968/2011

English (EN) (546.37 KB - PDF)

First published: Last updated:
View

български (BG) (625.38 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

español (ES) (543.72 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

čeština (CS) (670.39 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

dansk (DA) (543.79 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Deutsch (DE) (546.13 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

eesti keel (ET) (544.01 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

ελληνικά (EL) (633.13 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

français (FR) (546 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

italiano (IT) (542.82 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

latviešu valoda (LV) (608.53 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

lietuvių kalba (LT) (567.61 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

magyar (HU) (600.79 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Malti (MT) (612.74 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Nederlands (NL) (543.74 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

polski (PL) (1.09 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

português (PT) (543.7 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

română (RO) (567.9 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

slovenčina (SK) (609.79 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

slovenščina (SL) (599.18 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Suomi (FI) (544.93 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

svenska (SV) (542.67 KB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Product information

Rasitrio : EPAR - Product Information

English (EN) (4.55 MB - PDF)

First published: Last updated:
View

български (BG) (10.89 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

español (ES) (4.66 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

čeština (CS) (8 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

dansk (DA) (4.42 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Deutsch (DE) (4.78 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

eesti keel (ET) (2.92 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

ελληνικά (EL) (10.67 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

français (FR) (5.2 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

íslenska (IS) (4.53 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

italiano (IT) (3.02 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

latviešu valoda (LV) (8.2 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

lietuvių kalba (LT) (5.02 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

magyar (HU) (8.24 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Malti (MT) (8.6 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Nederlands (NL) (4.66 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

norsk (NO) (4.58 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

polski (PL) (8.54 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

português (PT) (4.6 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

română (RO) (5.27 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

slovenčina (SK) (8.17 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

slovenščina (SL) (8.29 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

Suomi (FI) (4.65 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View

svenska (SV) (4.53 MB - PDF)

First published: 19/12/2011 Last updated: 20/09/2012
View
Latest procedure affecting product information:IB/0015
03/10/2013
icon globe

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)

First published: Last updated:
View

български (BG) (608.24 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

español (ES) (497.14 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

čeština (CS) (1 MB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

dansk (DA) (496.37 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

Deutsch (DE) (497.7 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

eesti keel (ET) (496.69 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

ελληνικά (EL) (610.98 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

français (FR) (500.89 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

íslenska (IS) (493.62 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

italiano (IT) (497.22 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

latviešu valoda (LV) (580.69 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

lietuvių kalba (LT) (527.73 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

magyar (HU) (590.84 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

Malti (MT) (562.9 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

Nederlands (NL) (496.21 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

norsk (NO) (490.07 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

polski (PL) (1.02 MB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

português (PT) (497.58 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

română (RO) (527.11 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

slovenčina (SK) (578.02 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

Suomi (FI) (496.74 KB - PDF)

First published: 19/12/2011 Last updated: 19/12/2011
View

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

Rasitrio : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (972.03 KB - PDF)

First published: Last updated:
View

Rasitrio-H-C-2017-A20-1 : EPAR - Assessment Report - Article 20

Adopted Reference Number: EMA/390642/2012

English (EN) (908.97 KB - PDF)

First published: Last updated:
View

Rasitrio : EPAR - Public assessment report

Adopted

English (EN) (2.56 MB - PDF)

First published: Last updated:
View

CHMP summary of positive opinion for Rasitrio

Adopted Reference Number: EMA/CHMP/746483/2011

English (EN) (672.2 KB - PDF)

First published: Last updated:
View

More information on Rasitrio

Questions and answers on the review aliskiren-containing medicines

Reference Number: EMA/113677/2012

English (EN) (60.98 KB - PDF)

First published: Last updated:
View

Questions and answers on ongoing review of aliskiren-containing medicines

Reference Number: EMA/990270/2011

English (EN) (65.3 KB - PDF)

First published: Last updated:
View
This page was last updated on

Share this page

Back to top