Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Intrinsa
Auth. number : EU/1/06/352
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 UK Ltd
Old Belfast Road, Millbrook, Larne, County Antrim BT40 2SH, United Kingdom

  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
03/08/2006 Centralised - Authorisation EMEA/H/C/634 (2006)3522 of 28/07/2006
17/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/1
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/3
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/2
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/5
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/7
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/6
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/8
10/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/4
09/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/9
26/09/2007 Centralised - Variation EMEA/H/C/634/IA/10
Updated with Decision(2008)1519 of 14/04/2008
16/04/2008 Centralised - Variation (2008)1519 of 14/04/2008
24/04/2008 Centralised - Variation EMEA/H/C/634/II/11 (2008)1684 of 22/04/2008
16/09/2008 Centralised - Variation EMEA/H/C/634/IB/12
Updated with Decision(2009)2726 of 03/04/2009
08/04/2009 Centralised - Variation (2009)2726 of 03/04/2009
30/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/634/IA/14
14/04/2010 Centralised - Variation EMEA/H/C/634/IA/15/G
Updated with Decision(2010)3644 of 02/06/2010
04/06/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/634/T/16 (2010)3644 of 02/06/2010
06/12/2010 Centralised - Variation EMEA/H/C/634/IA/17/G
Updated with Decision(2011)5295 of 18/07/2011
20/07/2011 Centralised - Renewal EMEA/H/C/634/R/18 (2011)5295 of 18/07/2011
31/05/2012 Centralised - Withdrawal (2012)3599 of 25/05/2012