Livensa
Withdrawn
This medicine's authorisation has been withdrawn
testosterone
MedicineHumanWithdrawn
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- 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decision the European Public Assessment Report for Livensa is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:R/0016
18/07/2011
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).
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 systemTherapeutic 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.
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