Medicine
Myrbetriq 25 mg extended-release tablet
Myrbetriq 25 mg extended-release tablet is a prescription medicine containing Mirabegron for oral use, marketed by Astellas Pharma, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store and Dispense Store at 20°C to 25°C (68°F to 77°F) with excursions…
Key facts
- Active ingredient (INN)
- Mirabegron
- Brand
- Myrbetriq
- Strength
- 25 mg
- Dosage form
- Extended-release tablet
- Route
- Oral
- Packs
- 1 bottle
- Marketing authorisation holder
- Astellas Pharma
- Manufacturer
- Astellas Pharma
- Origin register
- US FDA, United States
- Storage
- Store and Dispense Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F). logo.jpg logo.jpg MYRBETRIQ Granules (mirabegron for extended-release oral suspension) MYRBETRIQ Granules (mirabegron for extended-release oral suspension) is supplied as granules in bottles with a child-resistant cap packaged in an aluminum pouch with desiccant.
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- G04BD12 Mirabegron
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 28 June 2012
- Identifiers
- RxCUI 1300791, 1300797, 1300801 +3DailyMed set ID ba9e9e15-e666-4c56-9271-2e24739cfa2dNDC 0469-2601Application NDA202611
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 carton / 30 tablet, film coated, extended release in 1 bottle | 0469-2601-30 | Astellas Pharma | 28 June 2012 |
| 1 bottle in 1 carton / 90 tablet, film coated, extended release in 1 bottle | 0469-2601-90 | Astellas Pharma | 28 June 2012 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Mirabegron 25 mg extended-release tablet.
Other strengths and forms of Mirabegron
Clinical summary
Mirabegron is a beta3-adrenergic agonist indicated for the treatment of overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency, either alone or in combination with the muscarinic antagonist solifenacin succinate. MedsAcross supplies Mirabegron for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MirabegronFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Myrbetriq prescribing information (Astellas Pharma) · U.S. National Library of Medicine, DailyMed
- Betmiga: European public assessment report (EPAR) · European Medicines Agency
Need Myrbetriq 25 mg extended-release tablet for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.