Approval · Notice of Compliance 21973 · 2019
KUVAN: Notice of Compliance 21973
Issued March 14, 2019
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
- 21973
- Date
- March 14, 2019
- Company
- Biomarin International LimitedRingaskiddy, Cork, Ireland
- Product type
- Prescription Pharmaceutical
- Submission
- New Drug Submission (NDS)
- Submission class
- Admin
- Reason
- Manufacturer name change
Products in this notice
Medicinal ingredients
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per PCK
- SAPROPTERIN DIHYDROCHLORIDE 500 MG per PCK
- SAPROPTERIN DIHYDROCHLORIDE 100 MG per TAB