Approval · Notice of Compliance 34447 · 2024
GALAFOLD: Notice of Compliance 34447
Issued November 25, 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
- 34447
- Date
- November 25, 2024
- Company
- Amicus Therapeutics Canada Inc.Toronto, Ontario, Canada
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Update to the Product Monograph with new safety and efficacy information / Update to Patient Medication Information / Update to package insert / Update to package labels
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| GALAFOLD | Not yet assigned | — |
Medicinal ingredients
- MIGALASTAT HYDROCHLORIDE 123 MG per CAP