Regulatory PathRegulatory requirements compared

Active substance

Bazedoxifene

Open in the medicines table

EMA European Union — centrally authorised medicines

Conbriza Pfizer Europe MA EEIG · Authorised · authorised 17 Apr 2009 · ATC G03XC02

Therapeutic indication (EMA)

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.

Brilence Wyeth Europa Ltd · Application withdrawn · ATC G03XC02

Safety signals and safety-related labeling changes

  • US FDA 4 Mar 2024 DUAVEE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for bazedoxifene →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.