Register of
Medicinal Products

Product class: Authorized package
Medicinal product class: For human use
Package code: 1633395
Name of medicinal product: ABILIFY MAINTENA
Active substances:
Aripiprazole
Estonian, English, Latin
ATC code: N05AX12
Dosage form: powder and solvent for prolonged-release suspension for injection
Route of administration: intramuscular use
Strengh: 300mg
Amount in package: 3TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information: lahusti 2 ml
Indication: ABILIFY MAINTENA is indicated for maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Safety features: Yes
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Otsuka Pharmaceutical Netherlands B.V. 
Marketing authorization number: EU/1/13/882 
Marketing authorization issued on: November 15, 2013 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: October 18, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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