| Active ingredient (INN) | Sapropterin Dihydrochloride |
|---|---|
| Brand names | Javygtor |
| Therapeutic category | Auto-created by FDA Drug Enforcement — Full Recall Database scraper |
| Controlled substance | No |
| Marketing-authorisation holders | BioMarin Pharmaceutical Australia Pty Ltd, HIKMA PHARMACEUTICALS USA INC., Camber Pharmaceuticals, Inc. |
| Registrations on file | 4 |
| Patient information leaflet (PIL) | Not on file |
| Summary of product characteristics (SPC) | Not on file |
| Product | Strength | Form | Market | MA holder | Status |
|---|---|---|---|---|---|
| KUVAN sapropterin dihydrochloride | 100 mg | — | 🇦🇺 AU | BioMarin Pharmaceutical Australia Pty Ltd | Active |
| KUVAN sapropterin dihydrochloride | 500 mg | — | 🇦🇺 AU | BioMarin Pharmaceutical Australia Pty Ltd | Active |
| sapropterin dihydrochloride | 100mg/1 | tablet | 🇺🇸 US | HIKMA PHARMACEUTICALS USA INC. | Active |
| Sapropterin dihydrochloride | 500mg/1 | solution | 🇺🇸 US | Camber Pharmaceuticals, Inc. | Active |