Approval · Notice of Compliance 33577 · 2024
INREBIC: Notice of Compliance 33577
Issued July 4, 2024
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
- 33577
- Date
- July 4, 2024
- Company
- Bristol-Myers Squibb CanadaSt-Laurent, Quebec, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update the product monograph with revised recommendations concerning concomitant administration of INREBIC (fedratinib) with CYP3A4 inhibitors as well as with dual inhibitors of CYP3A4 and CYP2C19 based on data from a Phase 1 clinical study and updated PBPK modeling
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| INREBIC | Not yet assigned | — |
Medicinal ingredients
- FEDRATINIB HYDROCHLORIDE 100 MG per CAP