Betmiga
mirabegron
Table of contents
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 28/04/2020
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 |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
20/12/2012
|
Contact address |
Product information
30/03/2020 Betmiga - EMEA/H/C/002388 - N/0034
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Urologicals
Therapeutic indication
Therapeutic indication
Symptomatic treatment of urgency.
Increased micturition frequency and / or urgency incontinence as may occur in adult patients with overactive-bladder syndrome.