Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Conbriza   
Auth. number : EU/1/09/511
INN : bazedoxifene
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G03 - Sex hormones and modulators of the genital system
Pharmacological subgroup: G03X - Other sex hormones and modulators of the genital system
Chemical subgroup: G03XC - Selective estrogen receptor modulators
Chemical substance: G03XC02 - Bazedoxifene
(See WHO ATC Index)
Indication: CONBRIZA is indicated for the treatment of postmenopausal osteoporosis in women at increased risk of fracture. A significant reduction in the incidence of vertebral fractures has been demonstrated; efficacy on hip fractures has not been established.

When determining the choice of CONBRIZA or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom

  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
21/04/2009 Centralised - Authorisation EMEA/H/C/913 (2009)3061 of 17/04/2009
01/09/2009 Centralised - Variation EMEA/H/C/913/IA/1
11/09/2009 Centralised - Variation EMEA/H/C/913/IA/2
11/09/2009 Centralised - Variation EMEA/H/C/913/IA/3
14/10/2009 Centralised - Variation EMEA/H/C/913/IA/4
14/10/2009 Centralised - Variation EMEA/H/C/913/IA/5
17/11/2009 Centralised - Variation EMEA/H/C/913/IA/6
05/02/2010 Centralised - Variation EMEA/H/C/913/IB/7
22/04/2010 Centralised - Variation EMEA/H/C/913/N/9
Updated with Decision(2010)5318 of 27/07/2010
27/04/2010 Centralised - Variation EMEA/H/C/913/IA/8/G
Updated with Decision(2010)5318 of 27/07/2010
29/07/2010 Centralised - Variation (2010)5318 of 27/07/2010
07/12/2010 Centralised - Variation EMEA/H/C/913/IB/11
Updated with Decision(2011)1186 of 21/02/2011
23/12/2010 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/913/T/12 (2010)9628 of 20/12/2010
23/02/2011 Centralised - Variation EMEA/H/C/913/II/10 (2011)1186 of 21/02/2011
23/03/2011 Centralised - Variation EMEA/H/C/913/IA/13
15/04/2011 Centralised - Variation EMEA/H/C/913/IA/14
Updated with Decision(2011)8236 of 10/11/2011
15/11/2011 Centralised - Variation (2011)8236 of 10/11/2011
31/05/2012 Centralised - Variation EMEA/H/C/913/II/21 (2012)3596 of 25/05/2012
03/10/2012 Referral EMEA/H/C/913/A-20/25 (2012)7053 of 01/10/2012
22/05/2013 Centralised - Variation EMEA/H/C/913/IB/31
Updated with Decision(2013)5485 of 14/08/2013
19/08/2013 Centralised - Modification EMEA/H/C/913/PSUR/30 (2013)5485 of 14/08/2013
19/02/2014 Centralised - Renewal EMEA/H/C/913/R/32 (2014)1137 of 17/02/2014