APO-MIRABEGRON DIN 02564971
Health Canada record
| Active ingredient(s) | MIRABEGRON 50 MG |
|---|---|
| Dosage form | Tablet (Extended-Release) |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | G04BD12 MIRABEGRON |
| Original market date | 01-Apr-2026 |
| Current status date | 01-Apr-2026 |
| Source | Health Canada DPD |
Establishment licence of the holder
Apotex Inc — licence 100375, currently licensed, last inspection rating C (2026-09-21).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MIRABEGRON
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02564963 | APO-MIRABEGRON | APOTEX INC | Tablet (Extended-Release) | MIRABEGRON 25 MG | Marketed |
| 02564955 | AURO-MIRABEGRON | AURO PHARMA INC | Tablet (Extended-Release) | MIRABEGRON 50 MG | Marketed |
| 02402874 | MYRBETRIQ | ASTELLAS PHARMA CANADA INC | Tablet (Extended-Release) | MIRABEGRON 25 MG | Marketed |
| 02402882 | MYRBETRIQ | ASTELLAS PHARMA CANADA INC | Tablet (Extended-Release) | MIRABEGRON 50 MG | Marketed |
| 02558483 | SANDOZ MIRABEGRON | SANDOZ CANADA INCORPORATED | Tablet (Extended-Release) | MIRABEGRON 50 MG | Approved |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 36808 | 2026-01-30 | Abbreviated New Drug Submission (ANDS) |
International API supply for MIRABEGRON
16 valid EDQM Certificates of Suitability from 15 holders. 40 active FDA Drug Master Files.
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