Product class:
|
Medicinal product with marketing authorization
|
Medicinal product class:
|
Human medicine
|
Name of medicinal product:
|
ABILIFY MAINTENA
|
Active substances:
|
|
ATC code:
|
N05AX12
|
Dosage form:
|
powder and solvent for prolonged-release suspension for injection in pre-filled syringe
|
Strength:
|
400mg
|
Legal status for supply*:
|
Subject to medicinal prescription
|
Summary of product characteristics (SPC):
|
|
Package information leaflet (PIL):
|
EST
|
Labelling:
|
|
Indication:
|
ABILIFY MAINTENA is indicated for maintenance treatment of schizophrenia in adult patients
stabilised with oral aripiprazole.
|
Safety features:
|
Yes
|
Marketing authorization holder:
|
Otsuka Pharmaceutical Netherlands B.V.
|
Marketing authorization number:
|
EU/1/13/882
|
Marketing authorization issued on:
|
April 28, 2016
|
Marketing authorization expires on:
|
Unlimited
|
Marketing authorization procedure type:
|
Centralised
|
Assessment report:
|
|
Package code
|
Name of medicinal product
|
Dosage form
|
Package
|
Legal status
|
Reimbursements
|
Reference price
|
Last imported
|
PƤritolumaa
|
Additional information
|
1717321
|
ABILIFY MAINTENA
|
powder and solvent for prolonged-release suspension for injection in pre-filled syringe
|
400mg 1TK
|
Prescription
|
|
|
|
|
lahusti 2 ml
|
1717332
|
ABILIFY MAINTENA
|
powder and solvent for prolonged-release suspension for injection in pre-filled syringe
|
400mg 3TK
|
Prescription
|
|
|
|
|
lahusti 2 ml
|
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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