Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prolia   
Auth. number : EU/1/10/618
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: Treatment of osteoporosis in postmenopausal women at increased risk of fractures. Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.
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
28/05/2010 Centralised - Authorisation EMEA/H/C/1120 (2010)3494 of 26/05/2010
22/09/2010 Centralised - Variation EMEA/H/C/1120/IB/1
Updated with Decision(2011)726 of 02/02/2011
16/11/2010 Centralised - Variation EMEA/H/C/1120/IA/2/G
Updated with Decision(2011)726 of 02/02/2011
06/12/2010 Centralised - Variation EMEA/H/C/1120/IB/4
10/01/2011 Centralised - Variation EMEA/H/C/1120/IB/5
01/02/2011 Centralised - Variation EMEA/H/C/1120/N/3
Updated with Decision(2011)6229 of 26/08/2011
04/02/2011 Centralised - Variation (2011)726 of 02/02/2011
05/07/2011 Centralised - Variation EMEA/H/C/1120/IA/6/G
Updated with Decision(2011)6229 of 26/08/2011
31/08/2011 Centralised - Variation (2011)6229 of 26/08/2011
29/02/2012 Centralised - Variation EMEA/H/C/1120/II/9 (2012)1377 of 27/02/2012
19/03/2012 Centralised - Variation EMEA/H/C/1120/II/10, 11 (2012)1858 of 15/03/2012
24/04/2012 Centralised - Variation EMEA/H/C/1120/II/12 (2012)2828 of 20/04/2012
06/09/2012 Centralised - Variation EMEA/H/C/1120/IAin/21/G
Updated with Decision(2012)7614 of 23/10/2012
26/10/2012 Centralised - Variation EMEA/H/C/1120/II/19 (2012)7614 of 23/10/2012
19/11/2012 Centralised - Variation EMEA/H/C/1120/II/18 (2012)8483 of 15/11/2012
22/01/2013 Centralised - Variation EMEA/H/C/1120/II/20
Updated with Decision(2013)9844 of 20/12/2013
25/04/2013 Centralised - Variation EMEA/H/C/1120/II/24
Updated with Decision(2013)9844 of 20/12/2013
25/07/2013 Centralised - Variation EMEA/H/C/1120/II/27
Updated with Decision(2013)9844 of 20/12/2013
02/08/2013 Centralised - Variation EMEA/H/C/1120/IB/29
Updated with Decision(2013)9844 of 20/12/2013
24/12/2013 Centralised - Variation (2013)9844 of 20/12/2013
05/06/2014 Centralised - Variation EMEA/H/C/1120/II/30 (2014)3826 of 03/06/2014
06/06/2014 Centralised - Variation EMEA/H/C/1120/N/41