Aregzilap

Medicinal product

(Invented) name

Aregzilap

Active substance (s)

Aripiprazolas

Strength

400 mg

Pharmaceutical form

milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai

Route (s) of administration

leisti į raumenis

Legal status for supply

Receptinis

Narrow therapeutic index (NTI)

ATC code (s)

N05AX12, Aripiprazole

Marketing authorisation holder

Sandoz d.d., Slovėnija

Date of authorisation

2025-11-28

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

10(1)

Procedure number

SE/H/2581/002/DC

Marketing authorisation procedure

Decentralizuota procedūra

Qualitative and quantitative composition

Flakone yra	1 vnt.
Aripiprazolas	400 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
119267	105371	1105371	flakonas	N1 (milteliai, tirpiklio flakonas (3 ml), 2 sterilūs švirkštai, 1 su adata paruošimui, 3 hipoderminės saugios adatos ir flakono adapteris)		Receptinis	LT/1/25/5910/001	Netiekiama	-	-	No	-	-
119268	105372	1105372	flakonas	N3 (milteliai, tirpiklio flakonas (3 ml), 2 sterilūs švirkštai, 1 su adata paruošimui, 3 hipoderminės saugios adatos ir flakono adapteris)		Receptinis	LT/1/25/5910/002	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2025-11-28	Registruotas