Approval · Notice of Compliance 30252 · 2023
EVRYSDI: Notice of Compliance 30252
Issued March 1, 2023
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
- 30252
- Date
- March 1, 2023
- Company
- Hoffmann-La Roche LimitedMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- This SNDS was accepted into Health Canada¿s (HC) implementation of ICH¿s Q12 Guideline pilot program. This supplement was filed to employ the partial use of Established Conditions (ECs) for selected drug substance and drug product sections of the eCTD, for approval of a Product Lifecycle Management Document (PLCM) document to support future post approval changes.
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| EVRYSDI | Not yet assigned | — |
Medicinal ingredients
- RISDIPLAM 0.75 MG per ML