OPSUMIT DIN 02561069
Health Canada record
| Active ingredient(s) | MACITENTAN 2.5 MG |
|---|---|
| Dosage form | Tablet For Suspension |
| Route | Oral |
| Schedule | PRESCRIPTION |
| Class | Human |
| ATC | C02KX04 MACITENTAN |
| Original market date | 27-Jan-2026 |
| Current status date | 27-Jan-2026 |
| 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 |
| 02521083 | OPSYNVI | JANSSEN INC | Tablet | MACITENTAN 10 MG; TADALAFIL 40 MG | Marketed |
Notices of Compliance
| NOC | Date | Submission | Reason |
|---|---|---|---|
| 35996 | 2025-09-12 | Supplement to a New Drug Submission (SNDS) | Addition of new pediatric indication: For the long-term treatment of pulmonary arterial hypertension (PAH, WHO Group I) in pediatric patients aged 2 to less than 18 years of WHO Function Class II-III whose PAH is either idiopathic or heritable, or associated with connective tissue disease or congenAddition of new strength: 2.5 mgital heart disease. Addition of new dosage form: Dispersible tablet . |
International API supply for MACITENTAN
14 active FDA Drug Master Files.
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