Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Livensa
Auth. number : EU/1/06/351
INN : testosterone
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03B - Androgens
Chemical subgroup: G03BA - 3-oxoandrosten (4) derivatives
Chemical substance: G03BA03 - Testosterone
(See WHO ATC Index)
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.
Marketing Authorisation Holder: Warner Chilcott Deutschland Gmbh
Dr.-Otto-Röhm-Straße 2-4, D-64331 Weiterstadt, Deutschland

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
01/08/2006 Centralised - Authorisation EMEA/H/C/630 (2006)3496 of 28/07/2006
17/11/2006 Centralised - Variation EMEA/H/C/630/IA/1
09/07/2007 Centralised - Variation EMEA/H/C/630/IA/7
09/07/2007 Centralised - Variation EMEA/H/C/630/IA/5
09/07/2007 Centralised - Variation EMEA/H/C/630/IA/6
09/07/2007 Centralised - Variation EMEA/H/C/630/IA/3
09/07/2007 Centralised - Variation EMEA/H/C/630/IA/8
10/07/2007 Centralised - Variation EMEA/H/C/630/IA/4
10/07/2007 Centralised - Variation EMEA/H/C/630/IA/2
09/08/2007 Centralised - Variation EMEA/H/C/630/IA/9
14/09/2007 Centralised - Variation EMEA/H/C/630/IA/10
Updated with Decision(2008)1520 of 14/04/2008
16/04/2008 Centralised - Variation (2008)1520 of 14/04/2008
29/04/2008 Centralised - Variation EMEA/H/C/630/II/11 (2008)1756 of 25/04/2008
17/09/2008 Centralised - Variation EMEA/H/C/630/IB/12
Updated with Decision(2009)2725 of 03/04/2009
08/04/2009 Centralised - Variation (2009)2725 of 03/04/2009
16/04/2010 Centralised - Variation EMEA/H/C/630/IA/14G
Updated with Decision(2010)8555 of 26/11/2010
01/12/2010 Centralised - Variation (2010)8555 of 26/11/2010
06/12/2010 Centralised - Variation EMEA/H/C/630/IA/15/G
Updated with Decision(2011)5294 of 18/07/2011
20/07/2011 Centralised - Renewal EMEA/H/C/630/R/16 (2011)5294 of 18/07/2011
19/03/2012 Centralised - Withdrawal (2012)1861 of 15/03/2012