Approval · Notice of Compliance 19124 · 2017
VECTIBIX: Notice of Compliance 19124
Issued April 5, 2017
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
- 19124
- Date
- April 5, 2017
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the product monographj and to the indication: vectibix is indicated for the treatment of previously untreated patients with non-mutated (wild type) ras metastatic colorectal carcinoma (mcrc) in combination with folfox (infusional 5-fluorouracil. leucovin and oxaliplatin). vectibix is indicated as monotherapy for the treatment of patients with non-mutated (wild type) ras mcrc after failure of fluoropyrimidine, oxaliplatin and irinotecan containing chemotherapy regimens.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VECTIBIX | Not yet assigned | — |
Medicinal ingredients
- PANITUMUMAB 20 MG per ML