Approval · Notice of Compliance 21507 · 2018
KUVAN: Notice of Compliance 21507
Issued November 8, 2018
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
- 21507
- Date
- November 8, 2018
- Company
- Biomarin Pharmaceutical IncNovato, California, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- New Form: Powder
Products in this notice
Medicinal ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per PCK
- SAPROPTERIN DIHYDROCHLORIDE 500 MG per PCK