Approval · Notice of Compliance 10029 · 2009
AVASTIN: Notice of Compliance 10029
Issued February 6, 2009
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.
Issued with conditions (NOC/c): the company must confirm the benefit in further studies.
- Notice number
- 10029
- Date
- February 6, 2009
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Indication: Avastin (bevacizumab) in combination with paclitaxel is indicated for the treatment of patients with metastatic HER2-negative breast cancer and who are ECOG Class 0-1
- Therapeutic class
- Antineoplastic
- With conditions
- Yes (NOC/c)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| AVASTIN | Not yet assigned | — |
Medicinal ingredients
- BEVACIZUMAB 25 MG per ML