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: tablet
Strength: 15mg
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):
Package information leaflet (PIL): EST
Labelling:  
Indication: ABILIFY is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. ABILIFY is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment (see section 5.1). ABILIFY is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older (see section 5.1).
Safety features: Yes
Marketing authorization holder: Otsuka Pharmaceutical Netherlands B.V. 
Marketing authorization number: EU/1/04/276 
Marketing authorization issued on: June 4, 2004 
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
1203567  ABILIFY  tablet  15mg 14TK  Prescription           
1203578  ABILIFY  tablet  15mg 28TK  Prescription  100% 50%  10,36  05.07.2024     
1203589  ABILIFY  tablet  15mg 49TK  Prescription           
1203590  ABILIFY  tablet  15mg 56TK  Prescription           
1203602  ABILIFY  tablet  15mg 98TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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