Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Adenuric   
Auth. number : EU/1/08/447
INN : febuxostat
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M04 - Antigout preparations
Pharmacological subgroup: M04A - Antigout preparations
Chemical subgroup: M04AA - Preparations inhibiting uric acid production
Chemical substance: M04AA03 - Febuxostat
(See WHO ATC Index)
Indication: Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of tophus and/or gouty arthritis).
Marketing Authorisation Holder: Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

  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
23/04/2008 Centralised - Authorisation EMEA/H/C/777 (2008)1648 of 21/04/2008
03/09/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/777/T/1 (2008)4824 of 01/09/2008
09/10/2008 Centralised - Variation EMEA/H/C/777/IB/2
Updated with Decision(2009)3812 of 07/05/2009
10/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IA/5
10/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IA/4
10/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IA/3
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IB/9
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IB/12
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IB/10
12/12/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IB/11
11/05/2009 Centralised - Variation (2009)3812 of 07/05/2009
26/05/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/777/T/13 (2009)4098 of 19/05/2009
22/12/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/777/T/14 (2009)10592 of 18/12/2009
13/04/2010 Centralised - Variation EMEA/H/C/777/IB/15
Updated with Decision(2010)6108 of 31/08/2010
03/05/2010 Centralised - Variation EMEA/H/C/777/IB/16/G
Updated with Decision(2010)6108 of 31/08/2010
03/09/2010 Centralised - Variation EMEA/H/C/777/II/17 (2010)6108 of 31/08/2010
26/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/777/IB/19/G
25/01/2011 Centralised - Variation EMEA/H/C/777/II/18 (2011)391 of 21/01/2011
30/03/2011 Centralised - Variation EMEA/H/C/777/II/20 (2011)2257 of 28/03/2011
31/03/2011 Centralised - Variation EMEA/H/C/777/IA/21/G
Updated with Decision(2011)8863 of 24/11/2011
29/11/2011 Centralised - Variation (2011)8863 of 24/11/2011
26/01/2012 Centralised - Variation EMEA/H/C/777/II/23 (2012)485 of 24/01/2012
26/10/2012 Centralised - Variation EMEA/H/C/777/II/27 (2012)7655 of 24/10/2012
24/12/2012 Centralised - Renewal EMEA/H/C/777/R/28 (2012)9934 of 20/12/2012
21/01/2014 Centralised - Modification EMEA/H/C/777/PSUV/33 (2014)309 of 16/01/2014
20/02/2014 Centralised - Variation EMEA/H/C/777/II/32
20/02/2014 Centralised - Variation EMEA/H/C/777/II/31