Drug · DIN 02350580
KUVAN
Yes: authorized and sold in Canada
Authorized, and the company reports that it sells it in Canada.
Status Marketed since April 11, 2019; first marketed July 5, 2010.
- Drug Identification Number (DIN)
- 02350580
- Company (DIN owner)
- Biomarin International LimitedRingaskiddy, Cork, Ireland
- Schedule
- Prescription
- Dosage form
- Tablet
- Route
- Oral
- Therapeutic class (ATC)
- Sapropterin A16AX07
- Class
- Human
- Record last updated
- July 10, 2026
Active ingredients
As listed in the Drug Product Database.
| Ingredient | Strength | Per |
|---|---|---|
| SAPROPTERIN DIHYDROCHLORIDE | 100 MG |
Notices of Compliance
Health Canada approvals that name this DIN.
- March 14, 2019: NOC 21973New Drug Submission (NDS) · Manufacturer name change
- April 30, 2010: NOC 11343New Drug Submission (NDS)
Other DINs named KUVAN
- DIN 02482207 · Marketed
- DIN 02482215 · Cancelled Post Market