Enviage

RSS
Withdrawn

This medicine's authorisation has been withdrawn

aliskiren
Medicine Human Withdrawn
  • 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 Enviage (aliskiren). Enviage is approved for the treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Enviage was Novartis Europharm Ltd. The European Commission was notified by letter dated 4 May 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Enviage for commercial reasons. 

As of 4 May 2010, Enviage has not been marketed anywhere in the European Union and there is no intention to market Enviage in the future. Enviage was an additional application to Rasilez, intended for co-marketing purposes. The MAH will maintain the Marketing Authorisations for the three other medicinal products containing aliskiren, i.e. Rasilez, Riprazo and Sprimeo. 

On 27 September 2010 the European Commission issued a decision to withdraw the marketing authorisation for Enviage. 

Pursuant to this decision the European Public Assessment Report for Enviage is updated to reflect that the marketing authorisation is no longer valid.

Enviage : EPAR - Summary for the public

English (EN) (258.97 KB - PDF)

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български (BG) (487.52 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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español (ES) (322.36 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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čeština (CS) (460.38 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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dansk (DA) (320.06 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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Deutsch (DE) (321.2 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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eesti keel (ET) (321.13 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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ελληνικά (EL) (507.25 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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français (FR) (322.97 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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italiano (IT) (322.49 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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latviešu valoda (LV) (447.6 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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lietuvių kalba (LT) (457.21 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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magyar (HU) (448.5 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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Malti (MT) (460.46 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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Nederlands (NL) (320.28 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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polski (PL) (467.04 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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português (PT) (322.74 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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română (RO) (430.96 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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slovenčina (SK) (455.68 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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slovenščina (SL) (444.82 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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Suomi (FI) (321.48 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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svenska (SV) (322.06 KB - PDF)

First published: 07/05/2009 Last updated: 19/05/2011
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Product information

Enviage : EPAR - Product Information

English (EN) (825.37 KB - PDF)

First published: Last updated:
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български (BG) (1.88 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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español (ES) (836.87 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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čeština (CS) (2.55 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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dansk (DA) (881.69 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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Deutsch (DE) (886.67 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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eesti keel (ET) (873.6 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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ελληνικά (EL) (1.93 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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français (FR) (875.32 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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íslenska (IS) (470.29 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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italiano (IT) (886.57 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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latviešu valoda (LV) (1.01 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
View

lietuvių kalba (LT) (1.43 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
View

magyar (HU) (1.31 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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Malti (MT) (1.46 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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Nederlands (NL) (844.24 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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norsk (NO) (470.15 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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polski (PL) (1.47 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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português (PT) (837.26 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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română (RO) (959.6 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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slovenčina (SK) (1.4 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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slovenščina (SL) (1.33 MB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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Suomi (FI) (839.52 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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svenska (SV) (837.77 KB - PDF)

First published: 08/06/2009 Last updated: 19/05/2011
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Latest procedure affecting product information:II/0034
22/04/2009
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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).

Enviage : EPAR - All Authorised presentations

English (EN) (214.1 KB - PDF)

First published: Last updated:
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български (BG) (295.76 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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español (ES) (213.98 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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čeština (CS) (253.25 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

dansk (DA) (214.18 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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Deutsch (DE) (214.17 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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eesti keel (ET) (213.37 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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ελληνικά (EL) (293.33 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

français (FR) (214.45 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

italiano (IT) (214.16 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

latviešu valoda (LV) (279.86 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

lietuvių kalba (LT) (291.19 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

magyar (HU) (289.01 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
View

Malti (MT) (288.76 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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Nederlands (NL) (214.07 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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polski (PL) (254.23 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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português (PT) (214.18 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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română (RO) (277.03 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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slovenčina (SK) (251.99 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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slovenščina (SL) (223.35 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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Suomi (FI) (214.53 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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svenska (SV) (214.26 KB - PDF)

First published: 03/09/2007 Last updated: 19/05/2011
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Product details

Name of medicine
Enviage
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/000850
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
27/09/2010
Revision
4

Assessment history

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

English (EN) (291.31 KB - PDF)

First published: Last updated:
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Enviage : EPAR - Procedural steps taken before authorisation

English (EN) (222.62 KB - PDF)

First published: Last updated:
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