Approval · Notice of Compliance 35996 · 2025
OPSUMIT: Notice of Compliance 35996
Issued September 12, 2025
A Notice of Compliance is Health Canada’s approval of a drug submission: a new drug, a new use or form, or a change to an approved one. The product itself is in the Drug Product Database, with its current status.
- Notice number
- 35996
- Date
- September 12, 2025
- Company
- Janssen Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- 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 .
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| OPSUMIT | Not yet assigned | — |
| OPSUMIT | 02561069 | Marketed |
Medicinal ingredients
- MACITENTAN 10 MG per TAB
- MACITENTAN 2.5 MG per TAB