Approval · Notice of Compliance 26195 · 2021
RIXIMYO: Notice of Compliance 26195
Issued June 30, 2021
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
- 26195
- Date
- June 30, 2021
- Company
- Sandoz Canada Inc.Saint-Hubert, Quebec, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New indication: Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) Riximyo in combination with glucocorticoids is indicated for the induction of remission in adult patients with severely active Granulomatosis with Polyangiitis (GPA, also known as Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA)
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| RIXIMYO | Not yet assigned | — |
Medicinal ingredients
- RITUXIMAB 10 MG per ML