Approval · Notice of Compliance 36366 · 2025
TNKASE: Notice of Compliance 36366
Issued November 13, 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
- 36366
- Date
- November 13, 2025
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication : Intravenous use in adults for the treatment of acute ischemic stroke (AIS). Treatment is to be initiated within 4.5 hours from the onset of AIS symptoms and after exclusion of intracranial haemorrhage. New strength
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TNKASE | Not yet assigned | — |
| TNKASE | 02562804 | Marketed |
Medicinal ingredients
- TENECTEPLASE 50 MG per VIAL
- TENECTEPLASE 25 MG per VIAL