Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Firmagon   
Auth. number : EU/1/08/504
INN : degarelix (as acetate)
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L02 - Endocrine therapy
Pharmacological subgroup: L02B - Hormone antagonists and related agents
Chemical subgroup: L02BX - Other hormone antagonists and related agents
Chemical substance: L02BX02 - Degarelix
(See WHO ATC Index)
Indication: FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated for treatment of adult male patients with advanced hormone-dependent prostate cancer.
Marketing Authorisation Holder: Ferring Pharmaceuticals A/S
Kay Fiskers Plads 11, DK-2300 København S, Danmark

  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
18/02/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/986 (2009)1189 of 17/02/2009
19/02/2009 Centralised - Authorisation EMEA/H/C/986 (2009)1188 of 17/02/2009
30/07/2009 Centralised - Variation EMEA/H/C/986/II/1 (2009)6066 of 24/07/2009
10/02/2010 Centralised - Variation EMEA/H/C/986/IB/2
11/02/2010 Centralised - Variation EMEA/H/C/986/IB/3
Updated with Decision(2010)7207 of 14/10/2010
15/06/2010 Centralised - Variation EMEA/H/C/986/IB/5
25/06/2010 Centralised - Variation EMEA/H/C/986/IA/6/G
Updated with Decision(2010)7207 of 14/10/2010
18/10/2010 Centralised - Variation (2010)7207 of 14/10/2010
25/11/2010 Centralised - Variation EMEA/H/C/986/IB/8/G
04/07/2012 Centralised - Variation EMEA/H/C/986/II/11 (2012)4584 of 28/06/2012
25/04/2013 Centralised - Variation EMEA/H/C/986/II/14/G
Updated with Decision(2013)8071 of 13/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/986/II/16
Updated with Decision(2013)8071 of 13/11/2013
25/07/2013 Centralised - Variation EMEA/H/C/986/II/15
Updated with Decision(2013)8071 of 13/11/2013
15/11/2013 Centralised - Modification EMEA/H/C/986/PSUV/20 (2013)8070 of 13/11/2013
15/11/2013 Centralised - Renewal EMEA/H/C/986/R/18 (2013)8071 of 13/11/2013
29/01/2014 Centralised - Variation EMEA/H/C/986/N/21
01/07/2014 Centralised - Variation EMEA/H/C/986/IA/24