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The marketing authorisation for Rasitrio has been withdrawn at the request of the marketing authorisation holder.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

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eesti keel (ET) (544.01 KB - PDF)

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ελληνικά (EL) (633.13 KB - PDF)

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français (FR) (546 KB - PDF)

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italiano (IT) (542.82 KB - PDF)

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latviešu valoda (LV) (608.53 KB - PDF)

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Nederlands (NL) (543.74 KB - PDF)

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polski (PL) (1.09 MB - PDF)

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português (PT) (543.7 KB - PDF)

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română (RO) (567.9 KB - PDF)

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slovenčina (SK) (609.79 KB - PDF)

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slovenščina (SL) (599.18 KB - PDF)

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Suomi (FI) (544.93 KB - PDF)

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svenska (SV) (542.67 KB - PDF)

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Product information

Rasitrio : EPAR - Product Information

English (EN) (4.55 MB - PDF)

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български (BG) (10.89 MB - PDF)

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español (ES) (4.66 MB - PDF)

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čeština (CS) (8 MB - PDF)

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dansk (DA) (4.42 MB - PDF)

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Deutsch (DE) (4.78 MB - PDF)

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eesti keel (ET) (2.92 MB - PDF)

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ελληνικά (EL) (10.67 MB - PDF)

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français (FR) (5.2 MB - PDF)

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íslenska (IS) (4.53 MB - PDF)

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italiano (IT) (3.02 MB - PDF)

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latviešu valoda (LV) (8.2 MB - PDF)

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lietuvių kalba (LT) (5.02 MB - PDF)

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magyar (HU) (8.24 MB - PDF)

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Malti (MT) (8.6 MB - PDF)

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Nederlands (NL) (4.66 MB - PDF)

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norsk (NO) (4.58 MB - PDF)

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polski (PL) (8.54 MB - PDF)

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português (PT) (4.6 MB - PDF)

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română (RO) (5.27 MB - PDF)

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slovenčina (SK) (8.17 MB - PDF)

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slovenščina (SL) (8.29 MB - PDF)

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Suomi (FI) (4.65 MB - PDF)

First published: 19/12/2011Last updated: 20/09/2012
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svenska (SV) (4.53 MB - PDF)

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

Rasitrio : EPAR - All Authorised presentations

English (EN) (492.71 KB - PDF)

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български (BG) (608.24 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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español (ES) (497.14 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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čeština (CS) (1 MB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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dansk (DA) (496.37 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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Deutsch (DE) (497.7 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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eesti keel (ET) (496.69 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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ελληνικά (EL) (610.98 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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français (FR) (500.89 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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íslenska (IS) (493.62 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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italiano (IT) (497.22 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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latviešu valoda (LV) (580.69 KB - PDF)

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lietuvių kalba (LT) (527.73 KB - PDF)

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magyar (HU) (590.84 KB - PDF)

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Malti (MT) (562.9 KB - PDF)

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Nederlands (NL) (496.21 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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norsk (NO) (490.07 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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polski (PL) (1.02 MB - PDF)

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português (PT) (497.58 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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română (RO) (527.11 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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slovenčina (SK) (578.02 KB - PDF)

First published: 19/12/2011Last updated: 19/12/2011
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Suomi (FI) (496.74 KB - PDF)

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

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

English (EN) (972.03 KB - PDF)

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

AdoptedReference Number: EMA/390642/2012

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Rasitrio : EPAR - Public assessment report

Adopted

English (EN) (2.56 MB - PDF)

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CHMP summary of positive opinion for Rasitrio

AdoptedReference Number: EMA/CHMP/746483/2011

English (EN) (672.2 KB - PDF)

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More information on Rasitrio

Questions and answers on the review aliskiren-containing medicines

Reference Number: EMA/113677/2012

English (EN) (60.98 KB - PDF)

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Questions and answers on ongoing review of aliskiren-containing medicines

Reference Number: EMA/990270/2011

English (EN) (65.3 KB - PDF)

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