Approval · Notice of Compliance 35313 · 2025
AUGTYRO: Notice of Compliance 35313
Issued May 7, 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
- 35313
- Date
- May 7, 2025
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- New Active Substance (NAS)
Products in this notice
Medicinal ingredients
- REPOTRECTINIB 40 MG per CAP
- REPOTRECTINIB 160 MG per CAP