Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ariclaim   
Auth. number : EU/1/04/283
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: indicated for ‘Diabetic Peripheral Neuropathic Pain (DPNP) 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/552 (2004)3160 of 11/08/2004
08/09/2004 Centralised - Variation EMEA/H/C/552/IA/1
Updated with Decision(2005)1734 of 03/06/2005
16/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/2
19/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/3
03/05/2005 Centralised - Variation EMEA/H/C/552/IA/4
Updated with Decision(2005)3579 of 15/09/2005
26/05/2005 Centralised - Variation EMEA/H/C/552/IB/5
Updated with Decision(2005)3579 of 15/09/2005
07/06/2005 Centralised - Variation EMEA/H/C/552 (2005)1734 of 03/06/2005
20/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/9
20/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/8
20/09/2005 Referral EMEA/H/C/552/A-18/652rev1 (2005)3579 of 15/09/2005
21/09/2005 Centralised - Variation EMEA/H/C/552/II/6, 7 (2005)3609 of 19/09/2005
18/11/2005 Centralised - Variation EMEA/H/C/552/II/11 (2005)4501 of 15/11/2005
31/03/2006 Centralised - Variation EMEA/H/C/552/II/10 (2006)1336 of 29/03/2006
20/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/14
02/06/2006 Centralised - Variation EMEA/H/C/552/II/13 (2006)2224 of 31/05/2006
03/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/II/15
31/10/2006 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/552/T/17 (2006)5242 of 27/10/2006
28/11/2006 Centralised - Variation EMEA/H/C/552/II/16 (2006)5858 of 24/11/2006
14/03/2007 Centralised - Notification EMEA/H/C/552/N/18
Updated with Decision(2007)4098 of 28/08/2007
10/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/21
25/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/23
11/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/20
21/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/28
30/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/27
31/08/2007 Centralised - Variation EMEA/H/C/552/II/22 (2007)4098 of 28/08/2007
26/11/2007 Centralised - Variation EMEA/H/C/552/II/24 (2007)5815 of 22/11/2007
10/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/29
18/12/2007 Centralised - Variation EMEA/H/C/552/X/25, 26 (2007)6675 of 14/12/2007
31/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/31
22/04/2008 Centralised - Variation EMEA/H/C/552/II/30 (2008)1629 of 18/04/2008
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/32
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/33
29/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/34
24/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/38
03/03/2009 Centralised - Variation EMEA/H/C/552/II/35 (2009)1545 of 27/02/2009
27/03/2009 Centralised - Variation EMEA/H/C/552/II/36 (2009)2317 of 25/03/2009
02/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/42
27/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/II/39
27/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/41
26/06/2009 Centralised - Renewal EMEA/H/C/552/R/37 (2009)5206 of 24/06/2009
02/07/2009 Centralised - Variation EMEA/H/C/552/II/40 (2009)5390 of 30/06/2009
16/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/43
24/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IB/44
25/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/45
03/09/2010 Centralised - Variation EMEA/H/C/552/WS/11/G (2010)6115 of 31/08/2010
20/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IG/31
03/02/2011 Centralised - Variation EMEA/H/C/552/WS/71 (2011)688 of 01/02/2011
09/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/552/IA/46/G
22/08/2011 Centralised - Variation EMEA/H/C/552/WS/135 (2011)6053 of 18/08/2011
17/11/2011 Centralised - Variation (rejected)
03/07/2013 Centralised - 2-Monthly update EMEA/H/C/552/WS/334/G (2013)4233 of 01/07/2013
24/10/2013 Centralised - Variation EMEA/H/C/552/WS/444
Updated with Decision(2014)7544 of 10/10/2014
14/10/2014 Centralised - Yearly update (2014)7544 of 10/10/2014