Approval · Notice of Compliance 29139 · 2022
BAMBEVI: Notice of Compliance 29139
Issued October 6, 2022
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
- 29139
- Date
- October 6, 2022
- Company
- Apotex Inc.Toronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: BAMBEVI in combination with carboplatin and gemcitabine is indicated for the treatment of patients with first recurrence platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer. These patients should not have received prior VEGF-targeted therapy including BAMBEVI.
- Canadian reference product
- AVASTIN
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| BAMBEVI | Not yet assigned | — |
Medicinal ingredients
- BEVACIZUMAB 100 MG per 4ML
- BEVACIZUMAB 400 MG per 16ML