Medicinal product name Betmiga
Pharmaceutical form Prolonged-release tablet
Strength 25 mg 
Information from the MAH on shortages Not notified
Legal status Rx Prescription (Pr.)
 Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website
ATC code G04BD12 Urologicals

Important notice

Additional information regarding the use for persons aged 75+

If used as "UROLOGICALS"
SubstanceClassComment
MirabegronumBLack of research evidence, clinical experience or efficacy among older persons. Elimination is reduced in renal insufficiency. Take interactions into account.

Medicinal products (1)

Availability of medicinal product Wholesalers Package size, content Primary packaging Maximum admissible pharmacy price (€ incl. VAT) Product No. Labelling
 Not available (according to the information provided by wholesalers) currently no information on availability from any wholesaler N10
(25 mg)
Al/Al blister    EU/1/12/809/001  Summary of product characteristics, patient information leaflet and labeling text approved by the European Medicines Agency is available on European Medicines Agency website

Registration information

Marketing authorisation No. EU/1/12/809/001
Date of authorisation Dec 20, 2012
MA valid until For unlimited time
Marketing authorisation holder, country Astellas Pharma Europe B.V., Netherlands