OPSYNVI DIN 02521083
Health Canada record
| Active ingredient(s) | MACITENTAN 10 MG; TADALAFIL 40 MG |
|---|---|
| Dosage form | Tablet |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C02KX54 MACITENTAN AND TADALAFIL |
| Original market date | 25-Nov-2021 |
| Current status date | 25-Nov-2021 |
| Source | Health Canada DPD |
Establishment licence of the holder
Janssen Inc — licence 100239, currently licensed, last inspection rating C (2026-03-09).
No Canadian shortage report is currently matched to this DIN.
Other Canadian products containing MACITENTAN
| DIN | Product | Company | Form | Strength | Status |
|---|---|---|---|---|---|
| 02415690 | OPSUMIT | JANSSEN INC | Tablet | MACITENTAN 10 MG | Marketed |
| 02561069 | OPSUMIT | JANSSEN INC | Tablet For Suspension | MACITENTAN 2.5 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 26835 | 2021-10-14 | New Drug Submission (NDS) |
International API supply for MACITENTAN
14 active FDA Drug Master Files.
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