Riprazo

RSS
Withdrawn

This medicine's authorisation has been withdrawn

aliskiren
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Riprazo has been withdrawn at the request of the marketing-authorisation holder.

Riprazo : EPAR - Summary for the public

English (EN) (187.23 KB - PDF)

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български (BG) (267.39 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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español (ES) (188.34 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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čeština (CS) (236.86 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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dansk (DA) (188.88 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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Deutsch (DE) (250.26 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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eesti keel (ET) (187.97 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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ελληνικά (EL) (275.64 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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français (FR) (250.06 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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italiano (IT) (192.22 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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latviešu valoda (LV) (242.57 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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lietuvių kalba (LT) (217.51 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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magyar (HU) (229.63 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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Malti (MT) (235.53 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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Nederlands (NL) (188.74 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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polski (PL) (297.59 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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português (PT) (264.01 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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română (RO) (218.03 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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slovenčina (SK) (278.35 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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slovenščina (SL) (228.45 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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Suomi (FI) (265.85 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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svenska (SV) (249.95 KB - PDF)

First published: 07/05/2009Last updated: 20/09/2012
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Product information

Riprazo : EPAR - Product Information

English (EN) (649.36 KB - PDF)

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български (BG) (902.17 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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español (ES) (619.59 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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čeština (CS) (789.29 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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dansk (DA) (637.46 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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Deutsch (DE) (669.55 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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eesti keel (ET) (654.53 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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ελληνικά (EL) (996.88 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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français (FR) (745.35 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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íslenska (IS) (675.49 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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italiano (IT) (757.31 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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latviešu valoda (LV) (810.27 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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lietuvių kalba (LT) (759.46 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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magyar (HU) (791.1 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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Malti (MT) (907.63 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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Nederlands (NL) (621.18 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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norsk (NO) (659.16 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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polski (PL) (843.1 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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português (PT) (721.42 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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română (RO) (689.67 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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slovenčina (SK) (835.24 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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slovenščina (SL) (788.82 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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Suomi (FI) (636.53 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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svenska (SV) (606.45 KB - PDF)

First published: 18/06/2009Last updated: 20/09/2012
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Latest procedure affecting product information: IG/0209/G
17/08/2012
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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).

Riprazo : EPAR - All Authorised presentations

English (EN) (225.29 KB - PDF)

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български (BG) (248.08 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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español (ES) (226.23 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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čeština (CS) (233.81 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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dansk (DA) (205.62 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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Deutsch (DE) (206.63 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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eesti keel (ET) (207.33 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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ελληνικά (EL) (250.29 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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français (FR) (209.37 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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íslenska (IS) (226.53 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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italiano (IT) (226.09 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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latviešu valoda (LV) (216.14 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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lietuvių kalba (LT) (539.5 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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magyar (HU) (241.81 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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Malti (MT) (235.35 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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Nederlands (NL) (226.03 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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norsk (NO) (228.5 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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polski (PL) (233.81 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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português (PT) (227.59 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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română (RO) (228.75 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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slovenčina (SK) (235.4 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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slovenščina (SL) (233.41 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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Suomi (FI) (228.05 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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svenska (SV) (227.48 KB - PDF)

First published: 03/09/2007Last updated: 20/09/2012
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Product details

Name of medicine
Riprazo
Active substance
aliskiren
International non-proprietary name (INN) or common name
aliskiren
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA02

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic indication

Treatment of essential hypertension.

Authorisation details

EMA product number
EMEA/H/C/000853
Marketing authorisation holder
Novartis Europharm Ltd.

Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Marketing authorisation issued
22/08/2007
Revision
8

Assessment history

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

English (EN) (615.62 KB - PDF)

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Riprazo-H-C-853-A20-69 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/CHMP/391141/2012

English (EN) (580.88 KB - PDF)

First published: Last updated:
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Riprazo-H-C-853-WS-37 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479605/2012

English (EN) (2.97 MB - PDF)

First published: Last updated:
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Riprazo-H-C-853-WS-169 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/479606/2012

English (EN) (347.5 KB - PDF)

First published: Last updated:
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Riprazo-H-C-853-WS-69 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/74385/2012

English (EN) (250.95 KB - PDF)

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Riprazo : EPAR - Scientific Discussion

English (EN) (755.14 KB - PDF)

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Riprazo : EPAR - Procedural steps taken before authorisation

English (EN) (144.23 KB - PDF)

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More information on Riprazo

Public statement on Riprazo: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/103518/2013

English (EN) (79.41 KB - PDF)

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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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