Betmiga

RSS

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 18/12/2017

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
10
Date of issue of marketing authorisation valid throughout the European Union
19/12/2012
Contact address
Sylviusweg 62
2333 BE Leiden
The Netherlands

Product information

17/09/2017 Betmiga - EMEA/H/C/002388 - R/0026

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

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

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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