Approval · Notice of Compliance 34202 · 2024
EVRYSDI: Notice of Compliance 34202
Issued October 16, 2024
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
- 34202
- Date
- October 16, 2024
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Priority
- Reason
- Change to existing indication: [expansion of pediatric indication to include patients under the age of 2 months]. Update to Patient Medication Information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EVRYSDI | Not yet assigned | — |
Medicinal ingredients
- RISDIPLAM 0.75 MG per ML