Approval · Notice of Compliance 35705 · 2025
PROCYSBI: Notice of Compliance 35705
Issued July 22, 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
- 35705
- Date
- July 22, 2025
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Change in the specification for the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| PROCYSBI | Not yet assigned | — |
Medicinal ingredients
- CYSTEAMINE BITARTRATE 25 MG per CAP
- CYSTEAMINE BITARTRATE 75 MG per CAP