Abilify Maintena

Medicinal product

(Invented) name

Abilify Maintena

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

Otsuka Pharmaceutical Netherlands B.V., Nyderlandai

Date of authorisation

2013-11-15

Date of renewal

Documents

Stage

Registruotas

Controlled?

Controlled substance type

Legal basis

8(3)

Procedure number

Marketing authorisation procedure

Centrinė registracija

Qualitative and quantitative composition

Powder and solvent for prolonged-release suspension for injection	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
58054	72178	1072178	flakonas	N1 (milteliai, tirpiklio flakonas (2 ml), 2 sterilūs švirkštai (1 su adata paruošimui), 2 hipoderminės saugios adatos (38 ir 50 mm), flakono adapteris)		Receptinis	EU/1/13/882/002	Tiekiama	-	-	No	-	-
58055	72179	1072179	flakonas	N3 (milteliai, tirpiklio flakonas (2 ml), 2 sterilūs švirkštai (1 su adata paruošimui), 2 hipoderminės saugios adatos (38 ir 50 mm), flakono adapteris) (daugiadozė)		Receptinis	EU/1/13/882/004	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-15	Registruotas