Approval · Notice of Compliance 9248 · 2007
ELOXATIN: Notice of Compliance 9248
Issued December 18, 2007
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
- 9248
- Date
- December 18, 2007
- Company
- Sanofi-Aventis Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: in combination with infusional 5-fluorouracil and leucovorin as adjuvant treatment of patients with stage III (duke's C) colon cancer after complete resection of primary tumor
- Therapeutic class
- Antineoplastic agent
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ELOXATIN | Not yet assigned | — |
Medicinal ingredients
- OXALIPLATIN 50 MG per VIAL
- OXALIPLATIN 100 MG per VIAL
- OXALIPLATIN 5 MG per ML