Livensa

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Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Livensa has been withdrawn at the request of the marketing authorisation holder.

Livensa : EPAR - Summary for the public

English (EN) (168.44 KB - PDF)

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български (BG) (298.14 KB - PDF)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Livensa : EPAR - Product Information

English (EN) (377.06 KB - PDF)

First published: Last updated:
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български (BG) (779.65 KB - PDF)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

First published: 26/09/2008Last 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: 08/09/2006Last updated: 16/04/2012
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español (ES) (120.96 KB - PDF)

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

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

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

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

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

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

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

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

First published: 08/09/2006Last updated: 16/04/2012
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latviešu valoda (LV) (162.55 KB - PDF)

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

lietuvių kalba (LT) (156.11 KB - PDF)

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

magyar (HU) (136.2 KB - PDF)

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

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

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

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

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

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

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

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

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

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

First published: 08/09/2006Last 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
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)

First published: Last updated:
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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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More information on Livensa

Public statement on Livensa (testosterone): withdrawal of the marketing authorisation in the European Union

AdoptedReference Number: EMA/222193/2012

English (EN) (107.69 KB - PDF)

First published: Last updated:
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