Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xgeva   
Auth. number : EU/1/11/703
INN : denosumab
ATC: Anatomical main group: M - Musculo-skeletal system
Therapeutic subgroup: M05 - Drugs for treatment of bone diseases
Pharmacological subgroup: M05B - Drugs affecting bone structure and mineralization
Chemical subgroup: M05BX - Other drugs affecting bone structure and mineralization
Chemical substance: M05BX04 - Denosumab
(See WHO ATC Index)
Indication: Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with bone metastases from solid tumours.
Marketing Authorisation Holder: Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, 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
15/07/2011 Centralised - Authorisation EMEA/H/C/2173 (2011)5194 of 13/07/2011
26/10/2011 Centralised - Variation EMEA/H/C/2173/IA/2
Updated with Decision(2012)646 of 31/01/2012
03/01/2012 Centralised - Variation EMEA/H/C/2173/IAin/4
Updated with Decision(2012)646 of 31/01/2012
02/02/2012 Centralised - Variation (2012)646 of 31/01/2012
23/03/2012 Centralised - Variation EMEA/H/C/2173/II/3 (2012)2022 of 21/03/2012
27/08/2012 Centralised - Variation EMEA/H/C/2173/II/9 (2012)6012 of 23/08/2012
17/09/2012 Centralised - Variation EMEA/H/C/2173/IA/12/G
Updated with Decision(2012)7867 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7867 of 29/10/2012
18/01/2013 Centralised - Variation EMEA/H/C/2173/II/14
Updated with Decision(2013)9733 of 18/12/2013
25/04/2013 Centralised - Variation EMEA/H/C/2173/II/19
Updated with Decision(2013)9733 of 18/12/2013
25/04/2013 Centralised - Variation EMEA/H/C/2173/II/18
Updated with Decision(2013)9733 of 18/12/2013
24/10/2013 Centralised - Variation EMEA/H/C/2173/II/11
Updated with Decision(2013)9733 of 18/12/2013
09/12/2013 Centralised - Variation EMEA/H/C/2173/IAIN/25
23/12/2013 Centralised - Variation (2013)9733 of 18/12/2013
27/05/2014 Centralised - Variation EMEA/H/C/2173/N/30