Drug · DIN 02561069
OPSUMIT
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since January 27, 2026; first marketed January 27, 2026.
- Drug Identification Number (DIN)
- 02561069
- Company (DIN owner)
- Janssen Inc.Toronto, Ontario, Canada
- Schedule
- Prescription
- Dosage form
- Tablet For Suspension
- Route
- Oral
- Therapeutic class (ATC)
- Macitentan C02KX04
- Class
- Human
- Record last updated
- March 6, 2026
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| MACITENTAN | 2.5 MG |
Notices of Compliance
Health Canada approvals that name this DIN.
- September 12, 2025: NOC 35996Supplement 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 .
Other DINs named OPSUMIT
- DIN 02415690 · Marketed