Duavive
oestrogens conjugated / bazedoxifene
Table of contents
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.
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List item
Duavive : EPAR - Summary for the public (PDF/77.59 KB)
First published: 30/01/2015
Last updated: 30/01/2015
EMA/668089/2014 -
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List item
Duavive : EPAR - Risk-management-plan summary (PDF/149.68 KB)
First published: 30/01/2015
Last updated: 29/10/2021
Authorisation details
Product details | |
---|---|
Name |
Duavive
|
Agency product number |
EMEA/H/C/002314
|
Active substance |
|
International non-proprietary name (INN) or common name |
|
Therapeutic area (MeSH) |
Postmenopause
|
Anatomical therapeutic chemical (ATC) code |
G03CC07
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
16/12/2014
|
Contact address |
Boulevard de la Plaine 17 |
Product information
19/06/2023 Duavive - EMEA/H/C/002314 - IB/0035
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
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.