Abilify Maintena

Medicinal product

(Invented) name

Abilify Maintena

Active substance (s)

Aripiprazolas

Strength

400 mg

Pharmaceutical form

milteliai ir tirpiklis pailginto atpalaidavimo injekcinei suspensijai užpildytame švirkšte

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 in pre-filled syringe	1.6 ml
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
62426	76834	1076834	užpildytas švirkštas	N1 ir 3 adatos (25, 38 ir 50 mm)		Receptinis	EU/1/13/882/006	Netiekiama	-	-	No	-	-
62427	76835	1076835	užpildytas švirkštas	N3x1 ir 3 adatos (25, 38 ir 50 mm) (daugiadozė)		Receptinis	EU/1/13/882/008	Netiekiama	-	-	No	-	-

Stadijos

Data	Stadija
2013-11-15	Registruotas