Approval · Notice of Compliance 12479 · 2011
RITUXAN: Notice of Compliance 12479
Issued July 11, 2011
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
- 12479
- Date
- July 11, 2011
- 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: single-agent maintenance treatment of previously untreated patients with advanced follicular non-Hodgkin's lymphoma with high tumour burden and who have responded to induction therapy with either CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) plus rituximab or CVP (cyclophosphamide, vincristine and prednisolone) plus rituximab
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RITUXAN | Not yet assigned | — |
Medicinal ingredients
- RITUXIMAB 10 MG per ML