4 authorised products containing Sapropterin hydrochloride, from the HPRA register.
| Medicine | Active substance | Licence holder | Status |
|---|---|---|---|
| Kuvan 100 mg powder for oral solution EU/1/08/481/004 |
Sapropterin hydrochloride | Biomarin International Limited | — |
| Kuvan 500 mg powder for oral solution EU/1/08/481/005 |
Sapropterin hydrochloride | Biomarin International Limited | — |
| Sapropterin Dipharma 100 mg Soluble tablet EU/1/21/1620/001-003 |
Sapropterin hydrochloride | Dipharma Arzneimittel GmbH | — |
| Sapropterin Dipharma 500 mg Powder for oral solution EU/1/21/1620/004 |
Sapropterin hydrochloride | Dipharma Arzneimittel GmbH | — |
Priya Life Science (2026). Irish Medicines Database. Available at: https://priyalifescience.com/medicines (Accessed: 7 July 2026).
Data: Health Products Regulatory Authority (HPRA) open dataset (“Authorised or Transfer Pending Products”), licensed CC BY 4.0, refreshed daily. Regulatory information only — not medical advice.