Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Betmiga   
Auth. number : EU/1/12/809
Active substance : mirabegron
ATC: Anatomical main group: G - Genito urinary system and sex hormones
Therapeutic subgroup: G04 - Urologicals
Pharmacological subgroup: G04B - Other urologicals, including antispasmodics
Chemical subgroup: G04BD - Urinary antispasmodics
Chemical substance: G04BD12 - mirabegron
(See WHO ATC Index)
Indication: Symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, 2333 BE Leiden, Nederland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
07/01/2013 Centralised - Authorisation EMEA/H/C/2388 (2012)9945 of 20/12/2012
19/02/2013 Centralised - Variation EMEA/H/C/2388/IAIN/1/G
Updated with Decision(2014)1249 of 20/02/2014
05/02/2014 Centralised - Variation EMEA/H/C/2388/IAIN/10/G
Updated with Decision(2014)1249 of 20/02/2014
24/02/2014 Centralised - Yearly update (2014)1249 of 20/02/2014
25/04/2014 PSUSA - Modification EMEA/H/C/2388/PSUV/7 (2014)2809 of 23/04/2014
21/11/2014 PSUSA - Modification EMEA/H/C/2388/PSUV/13 (2014)8881 of 19/11/2014
18/03/2015 PSUSA - Modification EMEA/H/C/2388/PSUV/15 (2015)1911 of 16/03/2015
16/09/2015 PSUSA - Modification EMEA/H/C/PSUSA/10031/201412 (2015)6383 of 14/09/2015
04/04/2016 PSUSA - Modification EMEA/H/C/PSUSA/10031/201506 (2016)2021 of 31/03/2016
20/09/2017 Centralised - Renewal EMEA/H/C/2388/R/26 (2017)6411 of 18/09/2017