Approval · Notice of Compliance 32614 · 2024
REPLAGAL: Notice of Compliance 32614
Issued January 26, 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
- 32614
- Date
- January 26, 2024
- Company
- Takeda Canada IncorporatedToronto, Ontario, Canada
- Product type
- Biologic
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Addition of an alternate manufacturing site for the drug substance
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| REPLAGAL | Not yet assigned | — |
Medicinal ingredients
- AGALSIDASE ALFA 1 MG per ML