Betmiga

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mirabegron

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 09/04/2019

Authorisation details

Product details
Name
Betmiga
Agency product number
EMEA/H/C/002388
Active substance
Mirabegron
International non-proprietary name (INN) or common name
mirabegron
Therapeutic area (MeSH)
Urinary Bladder, Overactive
Anatomical therapeutic chemical (ATC) code
G04BD12
Publication details
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Revision
11
Date of issue of marketing authorisation valid throughout the European Union
20/12/2012
Contact address
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

02/04/2019 Betmiga - EMEA/H/C/002388 - PSUSA/00010031/201806

Contents

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Pharmacotherapeutic group

UROLOGICALS

Therapeutic indication

Symptomatic treatment of urgency.

Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.

Assessment history

Changes since initial authorisation of medicine

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