Approval · Notice of Compliance 19936 · 2017
KUVAN: Notice of Compliance 19936
Issued October 19, 2017
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
- 19936
- Date
- October 19, 2017
- Company
- Biomarin Pharmaceutical IncNovato, California, United States
- Product type
- Prescription Pharmaceutical
- Submission
- Supplement to a New Drug Submission (SNDS), supplement
- Submission class
- Other
- Reason
- Design element changes to inner and outer labels and package insert
Products in this notice
| Brand | DIN | Status today |
|---|---|---|
| KUVAN | Not yet assigned | — |
Medicinal ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per TAB