Conbriza
bazedoxifene
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Conbriza. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Conbriza.
Authorisation details
Product details | |
---|---|
Name |
Conbriza
|
Agency product number |
EMEA/H/C/000913
|
Active substance |
bazedoxifene
|
International non-proprietary name (INN) or common name |
bazedoxifene
|
Therapeutic area (MeSH) |
Osteoporosis, Postmenopausal
|
Anatomical therapeutic chemical (ATC) code |
G03XC02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
17/04/2009
|
Contact address |
Boulevard de la Plaine 17 |
Product information
09/03/2021 Conbriza - EMEA/H/C/000913 - N/0055
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Sex hormones and modulators of the genital system
Therapeutic 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.