Tekturna

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Withdrawn

This medicine's authorisation has been withdrawn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Medicine Human Withdrawn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 Tekturna (aliskiren). Tekturna is approved for the treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Tekturna was Novartis Europharm Ltd. 

The European Commission was notified by letter dated 17 August 2009 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Tekturna for commercial reasons. Tekturna has not been marketed anywhere in the European Union and there is no intention to market Tekturna in the future. Tekturna was an additional application to Rasilez, intended for co-marketing purposes. The MAH will maintain the Marketing Authorisations for the four other medicinal products containing aliskiren, i.e. Rasilez, Enviage, Riprazo and Sprimeo. 

On 02 September 2009 the European Commission issued a decision to withdraw the marketing authorisation for Tekturna. 

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decision the European Public Assessment Report for Tekturna is updated to reflect that the marketing authorisation is no longer valid.

Tekturna : EPAR - Summary for the public

English (EN) (242.61 KB - PDF)

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български (BG) (488.89 KB - PDF)

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español (ES) (303.66 KB - PDF)

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čeština (CS) (437.46 KB - PDF)

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dansk (DA) (318.78 KB - PDF)

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Deutsch (DE) (304 KB - PDF)

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eesti keel (ET) (303.1 KB - PDF)

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ελληνικά (EL) (478.36 KB - PDF)

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français (FR) (304.02 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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italiano (IT) (522.79 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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latviešu valoda (LV) (440.95 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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lietuvių kalba (LT) (414.52 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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magyar (HU) (427.84 KB - PDF)

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Malti (MT) (439.26 KB - PDF)

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Nederlands (NL) (303.68 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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polski (PL) (444.02 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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português (PT) (303.95 KB - PDF)

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română (RO) (409.01 KB - PDF)

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slovenčina (SK) (434.07 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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slovenščina (SL) (425.31 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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Suomi (FI) (303.4 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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svenska (SV) (303.73 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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Product information

Tekturna : EPAR - Product Information

English (EN) (632.04 KB - PDF)

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български (BG) (2.67 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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español (ES) (633.36 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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čeština (CS) (2.01 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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dansk (DA) (884.15 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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Deutsch (DE) (672.49 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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eesti keel (ET) (1.05 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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ελληνικά (EL) (2.76 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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français (FR) (661.88 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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italiano (IT) (1.06 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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latviešu valoda (LV) (2.22 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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lietuvių kalba (LT) (1.13 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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magyar (HU) (1.1 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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Malti (MT) (1.21 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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Nederlands (NL) (641.57 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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polski (PL) (1.21 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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português (PT) (637.11 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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română (RO) (1.15 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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slovenčina (SK) (1.16 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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slovenščina (SL) (1.12 MB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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Suomi (FI) (638.08 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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svenska (SV) (638.86 KB - PDF)

First published: 09/09/2009 Last updated: 09/09/2009
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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).

Tekturna : EPAR - All Authorised presentations

English (EN) (436.83 KB - PDF)

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български (BG) (300.02 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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español (ES) (436.93 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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čeština (CS) (274.42 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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dansk (DA) (225.31 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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Deutsch (DE) (437.27 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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eesti keel (ET) (646.34 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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ελληνικά (EL) (323.36 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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français (FR) (438.33 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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italiano (IT) (649.04 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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latviešu valoda (LV) (757.09 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
View

lietuvių kalba (LT) (293.93 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
View

magyar (HU) (532.18 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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Malti (MT) (531.96 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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Nederlands (NL) (224.87 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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polski (PL) (275.17 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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português (PT) (437.53 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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română (RO) (502.13 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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slovenčina (SK) (495.31 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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slovenščina (SL) (465.27 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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Suomi (FI) (438.41 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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svenska (SV) (225.64 KB - PDF)

First published: 25/09/2009 Last updated: 25/09/2009
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Product details

Name of medicine
Tekturna
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/000852
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
02/09/2009
Revision
4

Assessment history

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

English (EN) (521.4 KB - PDF)

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Tekturna : EPAR - Scientific Discussion

English (EN) (680.34 KB - PDF)

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Tekturna : EPAR - Procedural steps taken before authorisation

English (EN) (226.74 KB - PDF)

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