Indications
Treatment of hyperphenylalaninaemia (HPA) in adult and paediatric patients with phenylketonuria (PKU).
Composition
- Active substance
- sepiapterin
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Sephience
- Active substance
- sepiapterin
- ATC code
- A16AX28
- Therapeutic area
- Phenylketonurias
- Marketing authorisation holder
- PTC Therapeutics International Limited
- Status
- Authorised
- EU authorisation
- 19 Jun 2025