Approval · Notice of Compliance 36004 · 2025
VYVGART: Notice of Compliance 36004
Issued September 5, 2025
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
- 36004
- Date
- September 5, 2025
- Company
- Argenx BvZwijnaarde, --, Belgium
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of a manufacturing facility for the drug product
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| VYVGART | Not yet assigned | — |
Medicinal ingredients
- EFGARTIGIMOD ALFA 20 MG per ML