Sephience

Medicinal product

(Invented) name

Sephience

Active substance (s)

Sepiapterinas

Strength

250 mg

Pharmaceutical form

geriamieji milteliai paketėlyje

Route (s) of administration

vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

A16AX28, sepiapterin

Marketing authorisation holder

PTC Therapeutics International Limited, Airija

Date of authorisation

2025-06-19

Date of renewal

Documents

Search in EMA Europe

Stage

Registruotas

Controlled?

No

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Paketėlyje yra	1 vnt.
Sepiapterinas	250 mg

Packages

PAKID	NPAKID	NPAKID-7	Pack type	Pack size	Type of packaging	Proposed dispensing/classification	Marketing authorisation no.	Supply status	From	To	Package is in foreign language	From	To	Mock-up
117891	103996	1103996	paketėlis	N30		Receptinis	EU/1/25/1939/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-06-19	Registruotas