Approval · Notice of Compliance 35207 · 2025
PROCYSBI: Notice of Compliance 35207
Issued April 17, 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
- 35207
- Date
- April 17, 2025
- Company
- Amgen Canada IncMississauga, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Administrative: Merger/Buy-out
Products in this notice
Medicinal ingredients
- CYSTEAMINE BITARTRATE 25 MG per CAP
- CYSTEAMINE BITARTRATE 75 MG per CAP