Approval · Notice of Compliance 11343 · 2010
KUVAN: Notice of Compliance 11343
Issued April 30, 2010
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
- 11343
- Date
- April 30, 2010
- Company
- Biomarin Pharmaceutical IncNovato, California, United States
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Priority-NAS
- Therapeutic class
- Enzyme activator
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KUVAN | 02350580 | Marketed |
Medicinal ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per TAB