Approval · Notice of Compliance 18586 · 2016
KUVAN: Notice of Compliance 18586
Issued October 18, 2016
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
- 18586
- Date
- October 18, 2016
- Company
- Biomarin Pharmaceutical IncNovato, California, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- To extend the pediatric indication to include children 1 month to 4 years of age, provide population pharmacokinetic data regardeing children 4-6 years of age; and revise the product monograph based on new in vitro drug ineteraction studies and updates to the core safety data sheet
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KUVAN | Not yet assigned | — |
Medicinal ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per TAB