Approval · Notice of Compliance 13947 · 2012
ERBITUX: Notice of Compliance 13947
Issued December 20, 2012
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
- 13947
- Date
- December 20, 2012
- Company
- Imclone LlcBranchburg, New Jersey, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: for the treatment of EGFR-expressing K-ras wild-type metastatic colorectal carcinoma (mCRC) in combination with FOLFIRI (irinoteca, 5-fluorouracil, leucovorin) for first-line treatment.
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ERBITUX | Not yet assigned | — |
Medicinal ingredients
- CETUXIMAB 2 MG per ML