Table of contents
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||
26/10/2021 Betmiga - EMEA/H/C/002388 - IA/0038
This medicine’s product information is available in all official EU languages.
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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.
Symptomatic treatment of urgency.
Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.