Riprazo

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Withdrawn

This medicine's authorisation has been withdrawn

aliskiren
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 22 August 2007, the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Riprazo, (aliskiren), which had been approved for treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Riprazo was Novartis Europharm Ltd. 

On 24 January 2013, the European Commission issued a decision to withdraw the marketing authorisation for Riprazo, following its receipt of a letter dated 18 December 2012 notifying the Commission of the MAH’s decision to voluntarily withdraw the marketing authorisation for this product for commercial reasons. Riprazo was marketed in the following European countries: Spain (until 31 December 2012) and was not marketed in any other European country. 

Pursuant to this decision, the European public assessment report for Riprazo is updated to reflect that the marketing authorisation is no longer valid.

Riprazo : EPAR - Summary for the public

English (EN) (187.23 KB - PDF)

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български (BG) (267.39 KB - PDF)

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español (ES) (188.34 KB - PDF)

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čeština (CS) (236.86 KB - PDF)

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dansk (DA) (188.88 KB - PDF)

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Deutsch (DE) (250.26 KB - PDF)

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eesti (ET) (187.97 KB - PDF)

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ελληνικά (EL) (275.64 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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français (FR) (250.06 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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italiano (IT) (192.22 KB - PDF)

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latviešu (LV) (242.57 KB - PDF)

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lietuvių (LT) (217.51 KB - PDF)

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magyar (HU) (229.63 KB - PDF)

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Malti (MT) (235.53 KB - PDF)

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Nederlands (NL) (188.74 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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polski (PL) (297.59 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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português (PT) (264.01 KB - PDF)

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română (RO) (218.03 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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slovenčina (SK) (278.35 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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slovenščina (SL) (228.45 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 20/09/2012
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suomi (FI) (265.85 KB - PDF)

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svenska (SV) (249.95 KB - PDF)

Prima publicare: 07/05/2009 Cea mai recent: 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)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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español (ES) (619.59 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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čeština (CS) (789.29 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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dansk (DA) (637.46 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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Deutsch (DE) (669.55 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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eesti (ET) (654.53 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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ελληνικά (EL) (996.88 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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français (FR) (745.35 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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italiano (IT) (757.31 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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latviešu (LV) (810.27 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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lietuvių (LT) (759.46 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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magyar (HU) (791.1 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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Malti (MT) (907.63 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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Nederlands (NL) (621.18 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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polski (PL) (843.1 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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português (PT) (721.42 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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română (RO) (689.67 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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slovenčina (SK) (835.24 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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slovenščina (SL) (788.82 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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suomi (FI) (636.53 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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svenska (SV) (606.45 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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Íslenska (IS) (675.49 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 20/09/2012
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norsk (NO) (659.16 KB - PDF)

Prima publicare: 18/06/2009 Cea mai recent: 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)

Prima publicare: Cea mai recent:
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български (BG) (248.08 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

español (ES) (226.23 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

čeština (CS) (233.81 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

dansk (DA) (205.62 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

Deutsch (DE) (206.63 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

eesti (ET) (207.33 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
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ελληνικά (EL) (250.29 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

français (FR) (209.37 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

italiano (IT) (226.09 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

latviešu (LV) (216.14 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

lietuvių (LT) (539.5 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

magyar (HU) (241.81 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

Malti (MT) (235.35 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

Nederlands (NL) (226.03 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

polski (PL) (233.81 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

português (PT) (227.59 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

română (RO) (228.75 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

slovenčina (SK) (235.4 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

slovenščina (SL) (233.41 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

suomi (FI) (228.05 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

svenska (SV) (227.48 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

Íslenska (IS) (226.53 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
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norsk (NO) (228.5 KB - PDF)

Prima publicare: 03/09/2007 Cea mai recent: 20/09/2012
Vizualizare

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
Withdrawal of marketing authorisation
24/01/2013
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

Adopted Reference Number: EMA/CHMP/391141/2012

English (EN) (580.88 KB - PDF)

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Riprazo-H-C-853-WS-37 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/479605/2012

English (EN) (2.97 MB - PDF)

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Riprazo-H-C-853-WS-169 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/479606/2012

English (EN) (347.5 KB - PDF)

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Riprazo-H-C-853-WS-69 : EPAR - Assessment Report - Variation

Adopted Reference 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

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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