MAYZENT DIN 02543370
Health Canada record
| Active ingredient(s) | SIPONIMOD 1 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | L04AE03 SIPONIMOD |
| Original market date | |
| Current status date | 21-Nov-2023 |
| Source | Health Canada DPD |
Establishment licence of the holder
Novartis Pharmaceuticals Canada Inc — licence 100273, currently licensed, last inspection rating C (2025-01-14).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing SIPONIMOD
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02496429 | MAYZENT | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | SIPONIMOD 0.25 MG | Marketed |
| 02496437 | MAYZENT | NOVARTIS PHARMACEUTICALS CANADA INC | Tablet | SIPONIMOD 2 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 32160 | 2023-11-21 | Supplement to a New Drug Submission (SNDS) | Addition of new strength . Updates to the inner and outer labels. Updates to the Product Monograph . Updates to the package insert |
International API supply for SIPONIMOD
6 active FDA Drug Master Files.
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