Daybu

Medicinal product

(Invented) name

Daybu

Active substance (s)

Trofinetidas

Strength

200 mg/ml

Pharmaceutical form

geriamasis tirpalas

Route (s) of administration

vartoti per skrandžio vamzdelį, vartoti per burną

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

No

ATC code (s)

N07XX24, trofinetide

Marketing authorisation holder

Acadia Pharmaceuticals (Netherlands) B.V., Nyderlandai

Date of authorisation

2026-08-20

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

1 ml tirpalo yra:	1 ml
Trofinetidas	200 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
122180	108291	1108291	buteliukas	450 ml ir 2 dozavimo taurelės (30 ml ir 110 ml) N1		Receptinis	EU/1/26/2045/001	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2026-08-20	Registruotas