Intrinsa
Withdrawn
This medicine's authorisation has been withdrawn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 Intrinsa (testosterone). Intrinsa is approved for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy. The Marketing Authorisation Holder (MAH) responsible for Intrinsa was Warner Chilcott UK Ltd.
The European Commission was notified by letter dated 13 March 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Intrinsa for commercial reasons. On 25 May 2012 the European Commission issued a decision to withdraw the marketing authorisation for Intrinsa.
Pursuant to this decision the European Public Assessment Report for Intrinsa is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:R/0018
25/05/2012
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
- Intrinsa
- 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
Intrinsa is indicated for the treatment of hypoactive sexual desire disorder (HSDD) in bilaterally oophorectomised and hysterectomised (surgically induced menopause) women receiving concomitant estrogen therapy.
News on Intrinsa
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