SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|
| Sapropterin Amarox | 100 mg | Tablet · Oral use | 120 Bottle | SAR 13068.00 | Generic · Prescription | Saudi Amarox | Valid |
| Sapropterin Amarox | 500 mg | Powder for oral solution · Oral use | 30 Sachet | SAR 16335.00 | Generic · Prescription | Saudi Amarox | Valid |
| Sapropterin Amarox | 100 mg | Powder for oral solution · Oral use | 30 Sachet | SAR 3267.00 | Generic · Prescription | Saudi Amarox | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
EMA European Union — centrally authorised medicines
Kuvan BioMarin International Limited · Authorised · authorised 2 Dec 2008 · ATC A16AX07
Therapeutic indication (EMA)
Kuvan is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Kuvan is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
Sapropterin Dipharma Dipharma Arzneimittel GmbH · Authorised · authorised 16 Feb 2022 · ATC A16AX07
Therapeutic indication (EMA)
Sapropterin Dipharma is indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with phenylketonuria (PKU) who have been shown to be responsive to such treatment. Sapropterin Dipharma is also indicated for the treatment of hyperphenylalaninaemia (HPA) in adults and paediatric patients of all ages with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive to such treatment.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|
| KUVAN | 02350580 | 100 MG | TABLET · ORAL | BIOMARIN INTERNATIONAL LIMITED |
| KUVAN | 02482207 | 100 MG / SACHET | POWDER · ORAL | BIOMARIN INTERNATIONAL LIMITED |
| REDDY-SAPROPTERIN | 02534533 | 100 MG / SACHET | POWDER FOR SOLUTION · ORAL | DR REDDY'S LABORATORIES LTD |
| REDDY-SAPROPTERIN | 02535610 | 500 MG / SACHET | POWDER FOR SOLUTION · ORAL | DR REDDY'S LABORATORIES LTD |
Safety signals and safety-related labeling changes
- US FDA 26 Aug 2024 KUVAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 26 Aug 2024 KUVAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
All safety entries for sapropterin →
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.