Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Qutenza   
Auth. number : EU/1/09/524
INN : Capsaicin
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N01 - Anesthetics
Pharmacological subgroup: N01B - Anesthetics, local
Chemical subgroup: N01BX - Other local anesthetics
Chemical substance: N01BX04 - Capsaicin
(See WHO ATC Index)
Indication: Qutenza is indicated for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, 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
18/05/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/909 (2009)4048 of 15/05/2009
20/05/2009 Centralised - Authorisation EMEA/H/C/909 (2009)4047 of 15/05/2009
29/09/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/909/T/1 (2009)7528 of 25/09/2009
25/11/2009 Centralised - Variation EMEA/H/C/909/IA/3
09/12/2009 Centralised - Variation EMEA/H/C/909/IA/5
08/01/2010 Centralised - Variation EMEA/H/C/909/IB/4
14/01/2010 Centralised - Variation EMEA/H/C/909/IA/6
27/01/2010 Centralised - Variation EMEA/H/C/909/II/2 (2010)522 of 25/01/2010
17/02/2010 Centralised - Variation EMEA/H/C/909/IA/8
Updated with Decision(2010)8300 of 19/11/2010
06/05/2010 Centralised - Variation EMEA/H/C/909/IA/9
08/06/2010 Centralised - Variation EMEA/H/C/909/IA/10/G
19/08/2010 Centralised - Variation EMEA/H/C/909/IA/12/G
Updated with Decision(2010)8300 of 19/11/2010
21/09/2010 Centralised - Variation EMEA/H/C/90/IA/13/G
04/11/2010 Centralised - Variation EMEA/H/C/909/IA/15
22/11/2010 Centralised - Variation EMEA/H/C/909/IB/16
23/11/2010 Centralised - Variation (2010)8300 of 19/11/2010
14/12/2010 Centralised - Variation EMEA/H/C/909/IA/17/G
14/12/2010 Centralised - Variation EMEA/H/C/909/IB/18
25/02/2011 Centralised - Variation EMEA/H/C/909/II/14 (2011)1227 of 21/02/2011
15/11/2012 Centralised - Variation EMEA/H/C/909/II/24
Updated with Decision(2013)1536 of 11/03/2013
27/02/2013 Centralised - Variation EMEA/H/C/909/IAin/27
Updated with Decision(2014)1738 of 12/03/2014
13/03/2013 Centralised - Modification EMEA/H/C/909/PSUR/8 (2013)1536 of 11/03/2013
14/03/2014 Centralised - Variation (2014)1738 of 12/03/2014
25/04/2014 Centralised - Renewal EMEA/H/C/909/R/31 (2014)2810 of 23/04/2014