Approval · Notice of Compliance 12859 · 2011
RITUXAN: Notice of Compliance 12859
Issued December 12, 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
- 12859
- Date
- December 12, 2011
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- New Indication: RITUXAN in combiination with glucocorticoids is indicated for the induction of remission in adult patients with severely active Granulomatosis with Polyangitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangitis (MPA). Consideration should be given to current treatment guidelines for vasculitis
- Therapeutic class
- Antineoplastic
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RITUXAN | Not yet assigned | — |
Medicinal ingredients
- RITUXIMAB 10 MG per ML