SEPHIENCE

This brand name is authorized in United States. It is also authorized in Austria, Lithuania.

Active ingredients

The drug SEPHIENCE contains one active pharmaceutical ingredient (API):

1	Sepiapterin UNII CJQ26KO7HP - SEPIAPTERIN
	Sepiapterin is a natural precursor of the enzymatic co-factor BH4, a critical co-factor for phenylalanine hydroxylase (PAH). Sepiapterin acts as a dual pharmacological chaperone (sepiapterin and BH4 each with its own binding affinity to variant PAH), including PAH variants commonly found in PKU and known to be insensitive to BH4, to improve the activity of the defective PAH enzyme, achieving a high concentration of BH4 intracellularly.
	Read more about Sepiapterin

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
SEPHIENCE Oral powder	MPI, EU: SmPC	European Medicines Agency (EU)

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
LT	Valstybinė vaistų kontrolės tarnyba	1103996, 1103997
US	FDA, National Drug Code	52856-201, 52856-301