Approval · Notice of Compliance 28527 · 2022
KUVAN: Notice of Compliance 28527
Issued July 5, 2022
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
- 28527
- Date
- July 5, 2022
- Company
- Biomarin International LimitedRingaskiddy, Cork, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Updates to the Product Monograph. Convert the Product Monograph to the 2020 Master template format
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