Conbriza

RSS

bazedoxifene

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 08/01/2020

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
13
Date of issue of marketing authorisation valid throughout the European Union
17/04/2009
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/12/2019 Conbriza - EMEA/H/C/000913 - N/0050

Contents

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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.

Assessment history

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