Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1265240
Name of medicinal product: ABILIFY
Active substances:
Aripiprazole
Estonian, English, Latin
ATC code: N05AX12
Dosage form: solution for injection
Route of administration: intramuscular use
Strengh: 7,5mg 1ml
Amount in package: 1.3ml 1TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: August 31, 2022
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 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: September 13, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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