Approval · Notice of Compliance 37722 · 2026
KUVAN: Notice of Compliance 37722
Issued June 16, 2026
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
- 37722
- Date
- June 16, 2026
- Company
- Biomarin International LimitedRingaskiddy, Cork, Ireland
- 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 information
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KUVAN | Not yet assigned | — |
Medicinal ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per TAB
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per SACHET
- SAPROPTERIN DIHYDROCHLORIDE 500 MG per SACHET