Duavive

RSS

oestrogens conjugated / 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 Duavive. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Duavive.

For practical information about using Duavive, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 17/08/2018

Authorisation details

Product details
Name
Duavive
Agency product number
EMEA/H/C/002314
Active substance
  • oestrogens conjugated
  • bazedoxifene
International non-proprietary name (INN) or common name
oestrogens conjugated / bazedoxifene
Therapeutic area (MeSH)
Osteoporosis
Anatomical therapeutic chemical (ATC) code
G03CX
Publication details
Marketing-authorisation holder
Pfizer Europe MA EEIG
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
16/12/2014
Contact address

Boulevard de la Plaine 17
1050 Bruxelles
Belgium

Product information

02/08/2018 Duavive - EMEA/H/C/002314 - T/0018

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Sex hormones and modulators of the genital system

Therapeutic indication

Duavive is indicated for:

Treatment of oestrogen deficiency symptoms in postmenopausal women with a uterus (with at least 12 months since the last menses) for whom treatment with progestin-containing therapy is not appropriate.

The experience treating women older than 65 years is limited.

Assessment history

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