BETMIGA Prolonged-release tablet Ref.[7511] Active ingredients: Mirabegron

Source: European Medicines Agency (EU)  Revision Year: 2024  Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Product name and form

Betmiga 25 mg prolonged-release tablets.

Betmiga 50 mg prolonged-release tablets.

Pharmaceutical Form

Prolonged-release tablet.

Betmiga 25 mg tablets: Oval, brown tablet, debossed with the company logo and “325” on the same side.

Betmiga 50 mg tablets: Oval, yellow tablet, debossed with the company logo and “355” on the same side.

Qualitative and quantitative composition

Betmiga 25 mg prolonged-release tablets: Each tablet contains 25 mg of mirabegron.

Betmiga 50 mg prolonged-release tablets: Each tablet contains 50 mg of mirabegron.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Mirabegron

Mirabegron is a potent and selective beta3-adrenoceptor agonist. Mirabegron enhances urine storage function by stimulating beta3-adrenoceptors in the bladder.
List of Excipients

Core tablet:

Macrogol 8000 and 2 000 000
Hydroxypropylcellulose
Butylhydroxytoluene
Magnesium stearate

Film coating:

Betmiga 25 mg prolonged-release tablets:

Hypromellose 2910, 6 mPa.s
Macrogol 8000
Iron oxide yellow (E172)
Iron oxide red (E172)

Betmiga 50 mg prolonged-release tablets:

Hypromellose 2910, 6 mPa.s
Macrogol 8000
Iron oxide yellow (E172)

Pack sizes and marketing

Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands

Marketing authorization dates and numbers

EU/1/12/809/001 – 006
EU/1/12/809/008 – 013
EU/1/12/809/015 – 018

Date of first authorisation: 20 December 2012
Date of latest renewal: 18 September 2017

Drugs

Drug Countries
BETMIGA Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa
 
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