This is a summary of the European public assessment report (EPAR) for Betmiga. 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 Betmiga.
Betmiga : EPAR - Summary for the public (PDF/76.08 KB)
First published: 15/01/2013
Last updated: 15/10/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Urinary Bladder, Overactive
|Anatomical therapeutic chemical (ATC) code||
Astellas Pharma Europe B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
02/04/2019 Betmiga - EMEA/H/C/002388 - PSUSA/00010031/201806
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Symptomatic treatment of urgency.
Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.