Approval · Notice of Compliance 23670 · 2020
TRUXIMA: Notice of Compliance 23670
Issued May 22, 2020
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
- 23670
- Date
- May 22, 2020
- Company
- Celltrion Healthcare Co Ltd
- 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), TRUXIMA 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)
- Canadian reference product
- RITUXAN
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| TRUXIMA | Not yet assigned | — |
Medicinal ingredients
- RITUXIMAB 10 MG per ML