Discontinuation report KUVAN
| Report ID | 263882 |
| Drug Identification Number | 02482215 |
| Brand name | KUVAN |
| Common or Proper name | Kuvan |
| Company Name | BIOMARIN INTERNATIONAL LIMITED |
| Market Status | CANCELLED POST MARKET |
| Active Ingredient(s) | SAPROPTERIN DIHYDROCHLORIDE |
| Strength(s) | 500MG |
| Dosage form(s) | POWDER |
| Route of administration | ORAL ORAL |
| Packaging size | 500mg single-use packet |
| ATC code | A16AX |
| ATC description | OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS |
| Reason for discontinuation | Business reasons |
| Anticipated discontinuation date | 2025-08-19 |
| Actual discontinuation date | 2025-08-15 |
| Remaining supply date | 2025-09-05 |
| Discontinuation status | Discontinued |
| Discontinuation decision reversal | No |
| Information on remaining supply | Number of last lot distributed: Lot W0764843A, Expiration Date of Last Lot: 30.09.2026 |
| Company comments | |
| Health Canada comments | |
| Tier 3 Status | No |
| Contact Address | SHANBALLY RINGASKIDDY, CORK IRELAND P43R298 |
| Company contact information |
Version History
Click on "Compare" below to view the full report history and compare to other versions.
| Version Number | Date Updated | Language | |
|---|---|---|---|
| v5 | 2025-08-20 | French | Compare |
| v4 | 2025-08-20 | English | Compare |
| v3 | 2025-07-31 | French | Compare |
| v2 | 2025-07-31 | French | Compare |
| v1 | 2025-07-31 | English | Compare |
Showing 1 to 5 of 5