Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
| Version v4-FR | Version v4-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2025-08-25 | 2025-08-25 |
| Drug Identification Number | 02482215 | 02482215 |
| Brand name | KUVAN | KUVAN |
| Common or Proper name | Kuvan | Kuvan |
| Company Name | BIOMARIN INTERNATIONAL LIMITED | BIOMARIN INTERNATIONAL LIMITED |
| Ingredients | SAPROPTERIN DIHYDROCHLORIDE | SAPROPTERIN DIHYDROCHLORIDE |
| Strength(s) | 500MG | 500MG |
| Dosage form(s) | POWDER | POWDER |
| Route of administration | ORAL ORAL | ORAL ORAL |
| Packaging size | 500mg single-use packet | 500mg single-use packet |
| ATC code | A16AX | A16AX |
| ATC description | OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS | OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS |
| Reason for discontinuation | Business reasons | Business reasons |
| Anticipated discontinuation date | 2025-08-19 | 2025-08-19 |
| Actual discontinuation date | 2025-08-15 | 2025-08-15 |
| Remaining supply date | 2025-09-05 | 2025-09-05 |
| Discontinuation status | Discontinued | Discontinued |
| Discontinuation decision reversal | no | no |
| Tier 3 Status | No | No |
| Information on remaining supply | ||
| Company comments | ||
| Health Canada comments |