Livensa

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Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 28 July 2006 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Livensa (testosterone). Livensa is approved for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopausal) women receiving concomitant estrogen therapy. 

The Marketing Authorisation Holder (MAH) responsible for Livensa was Warner Chilcott Deutschland GmbH. The European Commission was notified by letter dated 06 February 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Livensa for commercial reasons. 

Livensa has not been marketed anywhere in the European Union and there is no intention to market Livensa in the future. On 15 March 2012 the European Commission issued a decision to withdraw the marketing authorisation for Livensa. 

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decision the European Public Assessment Report for Livensa is updated to reflect that the marketing authorisation is no longer valid.

Livensa : EPAR - Summary for the public

English (EN) (168.44 KB - PDF)

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български (BG) (298.14 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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español (ES) (169.76 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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čeština (CS) (273.22 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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dansk (DA) (230.75 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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Deutsch (DE) (231.16 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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eesti keel (ET) (229.87 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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ελληνικά (EL) (303.78 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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français (FR) (230.16 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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italiano (IT) (231.29 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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latviešu valoda (LV) (275.77 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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lietuvių kalba (LT) (195.76 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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magyar (HU) (267.45 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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Malti (MT) (211.01 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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Nederlands (NL) (229.84 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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polski (PL) (272.31 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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português (PT) (169.55 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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română (RO) (254.75 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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slovenčina (SK) (270.77 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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slovenščina (SL) (266.51 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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Suomi (FI) (244.98 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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svenska (SV) (230.23 KB - PDF)

First published: 21/07/2008 Last updated: 16/04/2012
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Product information

Livensa : EPAR - Product Information

English (EN) (377.06 KB - PDF)

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български (BG) (779.65 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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español (ES) (373.47 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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čeština (CS) (628.12 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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dansk (DA) (376.27 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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Deutsch (DE) (332.54 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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eesti keel (ET) (378.18 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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ελληνικά (EL) (812.94 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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français (FR) (383.13 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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íslenska (IS) (241.65 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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italiano (IT) (323.51 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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latviešu valoda (LV) (703.94 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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lietuvių kalba (LT) (463.76 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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magyar (HU) (610.27 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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Malti (MT) (665.37 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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Nederlands (NL) (382.03 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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norsk (NO) (241.85 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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polski (PL) (620.13 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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português (PT) (323.31 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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română (RO) (476.65 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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slovenčina (SK) (630.59 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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slovenščina (SL) (606.4 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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Suomi (FI) (378.28 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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svenska (SV) (378.43 KB - PDF)

First published: 26/09/2008 Last updated: 16/04/2012
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Latest procedure affecting product information:R/0016
18/07/2011
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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).

Livensa : EPAR - All Authorised presentations

English (EN) (122.11 KB - PDF)

First published: Last updated:
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български (BG) (172.13 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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español (ES) (120.96 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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čeština (CS) (156.51 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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dansk (DA) (115.87 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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Deutsch (DE) (115.58 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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eesti keel (ET) (115.96 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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ελληνικά (EL) (165.22 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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français (FR) (115.46 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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íslenska (IS) (26.59 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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italiano (IT) (115.34 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
View

latviešu valoda (LV) (162.55 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
View

lietuvių kalba (LT) (156.11 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
View

magyar (HU) (136.2 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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Malti (MT) (168.13 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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Nederlands (NL) (116.09 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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norsk (NO) (28.3 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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polski (PL) (139.63 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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português (PT) (115.26 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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română (RO) (154.64 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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slovenčina (SK) (153.87 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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slovenščina (SL) (139.83 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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Suomi (FI) (115.23 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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svenska (SV) (115.51 KB - PDF)

First published: 08/09/2006 Last updated: 16/04/2012
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Product details

Name of medicine
Livensa
Active substance
testosterone
International non-proprietary name (INN) or common name
testosterone
Therapeutic area (MeSH)
Sexual Dysfunctions, Psychological
Anatomical therapeutic chemical (ATC) code
G03BA03

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Livensa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.

Authorisation details

EMA product number
EMEA/H/C/000630
Marketing authorisation holder
Warner Chilcott  Deutschland GmbH

Warner Chilcott Deutschland GmbH
Dr.-Otto-Röhm-Strasse 2-4
D-64331 Weiterstadt
Germany

Marketing authorisation issued
28/07/2006
Withdrawal of marketing authorisation
15/03/2012
Revision
6

Assessment history

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

English (EN) (178.49 KB - PDF)

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Livensa : EPAR - Scientific Discussion

English (EN) (630.52 KB - PDF)

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Livensa : EPAR - Procedural steps taken before authorisation

English (EN) (123.6 KB - PDF)

First published: Last updated:
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