Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
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. |
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 8,000 and 2,000,000 Film coating: Betmiga 25 mg prolonged-release tablets: Hypromellose 2910, 6 mPa.s Betmiga 50 mg prolonged-release tablets: Hypromellose 2910, 6 mPa.s |
Alu-Alu blisters in cartons containing 10, 20, 30, 50, 60, 90, 100 or 200 tablets. HDPE bottles with child-resistant closure of polypropylene (PP) and a silica gel desiccant containing 90 tablets. Each carton contains one bottle.
Not all pack sizes may be marketed.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
EU/1/12/809/001-018
Date of first authorisation: 20 December 2012
Date of latest renewal: 18 September 2017
| 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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