Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Yentreve   
Auth. number : EU/1/04/280
Active substance : duloxetine hydrochloride
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N06 - Psychoanaleptics
Pharmacological subgroup: N06A - Antidepressants
Chemical subgroup: N06AX - Other antidepressants
Chemical substance: N06AX21 - Duloxetine
(See WHO ATC Index)
Indication: YENTREVE is indicated for women for the treatment of moderate to severe Stress Urinary Incontinence (SUI).
YENTREVE is indicated in adults.
Marketing Authorisation Holder: Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland
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
13/08/2004 Centralised - Authorisation EMEA/H/C/545 (2004)3159 of 11/08/2004
16/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IB/1
30/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IA/2
03/05/2005 Centralised - Variation EMEA/H/C/545/IA/3
Updated with Decision(2005)3580 of 15/09/2005
26/05/2005 Centralised - Variation EMEA/H/C/545/IB/4
Updated with Decision(2005)3580 of 15/09/2005
20/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IB/7
20/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IB/8
21/09/2005 Centralised - Variation EMEA/H/C/545/II/5, 6 (2005)3611 of 19/09/2005
21/09/2005 Referral EMEA/H/C/545/A-18/652rev1 (2005)3580 of 15/09/2005
21/11/2005 Centralised - Variation EMEA/H/C/545/II/10 (2005)4530 of 17/11/2005
31/03/2006 Centralised - Variation EMEA/H/C/545/II/9 (2006)1347 of 29/03/2006
20/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IA/13
02/06/2006 Centralised - Variation EMEA/H/C/545/II/12 (2006)2228 of 31/05/2006
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/II/15
25/08/2006 Centralised - Variation EMEA/H/C/545/II/17
Updated with Decision(2006)5923 of 28/11/2006
01/12/2006 Centralised - Variation EMEA/H/C/545/II/16 (2006)5923 of 28/11/2006
14/03/2007 Centralised - Notification EMEA/H/C/545/N/18
Updated with Decision(2007)4097 of 28/08/2007
12/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IA/21
11/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IB/20
21/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IB/23
30/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IB/24
31/08/2007 Centralised - Variation EMEA/H/C/545/II/22 (2007)4097 of 28/08/2007
25/04/2008 Centralised - Variation EMEA/H/C/545/II/26 (2008)1701 of 23/04/2008
24/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IA/33
08/04/2009 Centralised - Variation EMEA/H/C/545/II/31 (2009)2717 of 03/04/2009
12/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/II/34
25/06/2009 Centralised - Renewal EMEA/H/C/545/R/32 (2009)5205 of 24/06/2009
09/07/2009 Centralised - Variation EMEA/H/C/545/II/35 (2009)5597 of 07/07/2009
02/09/2010 Centralised - Variation EMEA/H/C/545/WS/11/G (2010)6097 of 31/08/2010
03/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IG/31
25/01/2011 Centralised - Variation EMEA/H/C/545/WS/71 (2011)399 of 21/01/2011
15/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/545/IA/36/G
29/07/2011 Centralised - Variation EMEA/H/C/545/WS/135 (2011)5579 of 27/07/2011
03/07/2013 Centralised - 2-Monthly update EMEA/H/C/545/WS/334/G (2013)4228 of 01/07/2013
24/10/2013 Centralised - Variation EMEA/H/C/545/WS/444/46
Updated with Decision(2014)7476 of 08/10/2014
10/10/2014 Centralised - Yearly update (2014)7476 of 08/10/2014
29/05/2015 PSUSA - Modification EMEA/H/C/545/PSUSA/1187/201408 (2015)3645 of 27/05/2015