Register of
Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: ABILIFY
Active substances:
Aripiprazole
Estonian, English, Latin
ATC code: N05AX12
Dosage form: solution for injection
Strength: 7,5mg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: ABILIFY solution for injection is indicated for the rapid control of agitation and disturbed behaviours in adult patients with schizophrenia or with manic episodes in Bipolar I Disorder, when oral therapy is not appropriate. Treatment with ABILIFY solution for injection should be discontinued as soon as clinically appropriate and the use of oral aripiprazole should be initiated.
Safety features: Yes
Marketing authorization holder: Otsuka Pharmaceutical Netherlands B.V. 
Marketing authorization number: EU/1/04/276 
Marketing authorization issued on: October 4, 2006 
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 Additional information
1265240  ABILIFY  solution for injection  7,5mg 1ml 1.3ml 1TK  Prescription      31.08.2022   
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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