Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xeristar   
Auth. number : EU/1/04/297
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: Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Xeristar 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
22/12/2004 Centralised - Authorisation EMEA/H/C/573 (2004)5380 of 17/12/2004
03/02/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/2
16/02/2005 Centralised - Variation EMEA/H/C/573/IA/1
Updated with Decision(2005)2576 of 04/07/2005
01/03/2005 Centralised - Variation EMEA/H/C/573/IA/3
Updated with Decision(2005)2576 of 04/07/2005
30/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/6
23/05/2005 Centralised - Variation EMEA/H/C/573/IB/7
Updated with Decision(2005)2576 of 04/07/2005
30/06/2005 Centralised - Variation EMEA/H/C/573/IB/8
Updated with Decision(2005)3581 of 15/09/2005
06/07/2005 Centralised - Variation EMEA/H/C/573/II/5 (2005)2577 of 04/07/2005
06/07/2005 Centralised - Variation EMEA/H/C/573/II/4 (2005)2576 of 04/07/2005
16/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/9
16/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/10
21/09/2005 Referral EMEA/H/C/573/A-18/652rev1 (2005)3581 of 15/09/2005
03/12/2005 Centralised - Variation EMEA/H/C/573/IB/13
Updated with Decision(2006)1346 of 29/03/2006
31/03/2006 Centralised - Variation EMEA/H/C/573/II/11 (2006)1346 of 29/03/2006
20/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/15
27/04/2006 Centralised - Variation EMEA/H/C/573/IA/16
Updated with Decision(2006)2218 of 31/05/2006
02/06/2006 Centralised - Variation EMEA/H/C/573/II/14 (2006)2218 of 31/05/2006
18/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/II/17
28/11/2006 Centralised - Variation EMEA/H/C/573/II/18 (2006)5873 of 24/11/2006
14/03/2007 Centralised - Notification EMEA/H/C/573/N/19
Updated with Decision(2007)4096 of 28/08/2007
29/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/22
11/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/20
25/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/24
11/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/21
31/08/2007 Centralised - Variation EMEA/H/C/573/II/23 (2007)4096 of 28/08/2007
12/09/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/25
12/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/28
31/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/30
23/04/2008 Centralised - Variation EMEA/H/C/573/II/29 (2008)1653 of 21/04/2008
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/32
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/34
30/07/2008 Centralised - Variation EMEA/H/C/573/II/27 (2008)4116 of 28/07/2008
05/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/33
10/12/2008 Centralised - Variation (rejected) EMEA/H/C/573/II/26 (2008)8335 of 08/12/2008
24/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/39
27/02/2009 Centralised - Variation EMEA/H/C/573/II/35 (2009)1446 of 26/02/2009
27/03/2009 Centralised - Variation EMEA/H/C/573/II/37 (2009)2288 of 25/03/2009
02/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/43
27/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/42
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/II/40
29/06/2009 Centralised - Renewal EMEA/H/C/573/R/38 (2009)5207 of 24/06/2009
03/07/2009 Centralised - Variation EMEA/H/C/573/II/41 (2009)5400 of 01/07/2009
31/08/2009 Centralised - Variation EMEA/H/C/573/II/44 (2009)6711 of 27/08/2009
17/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/45
24/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IA/47
24/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/46
24/11/2009 Centralised - Variation EMEA/H/C/573/II/36 (2009)9339 of 20/11/2009
12/05/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/573/T/48 (2010)3170 of 10/05/2010
08/09/2010 Centralised - Variation EMEA/H/C/573/WS/11/G (2010)6226 of 06/09/2010
17/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IG/31
01/02/2011 Centralised - Variation EMEA/H/C/573/WS/71 (2011)561 of 27/01/2011
28/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/573/IB/49
21/07/2011 Centralised - Variation (rejected) EMEA/H/C/573/II/WS/76
28/07/2011 Centralised - Variation EMEA/H/C/573/WS/135 (2011)5522 of 26/07/2011
10/08/2011 Centralised - Notification EMEA/H/C/573/N/50
Updated with Decision(2013)4359 of 04/07/2013
13/03/2012 Centralised - Notification EMEA/H/C/573/N/57
Updated with Decision(2013)4359 of 04/07/2013
08/07/2013 Centralised - 2-Monthly update EMEA/H/C/573/WS/334/G (2013)4359 of 04/07/2013
24/10/2013 Centralised - Variation EMEA/H/C/573/WS/444
Updated with Decision(2014)7658 of 15/10/2014
20/03/2014 Centralised - Variation EMEA/H/C/573/WS/513
Updated with Decision(2014)7658 of 15/10/2014
26/06/2014 Centralised - Variation EMEA/H/C/573/WS/490
Updated with Decision(2014)7658 of 15/10/2014
17/10/2014 Centralised - Yearly update (2014)7658 of 15/10/2014