Approval · Notice of Compliance 9781 · 2008
ERBITUX: Notice of Compliance 9781
Issued September 11, 2008
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
- 9781
- Date
- September 11, 2008
- Company
- Imclone Systems Incorporated
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New indication: erbitux (cetuximab) is indicated in combination with radiation therapy for the initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| ERBITUX | Not yet assigned | — |
Medicinal ingredients
- CETUXIMAB 2 MG per ML