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: 30mg
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 Additional information
1203613  ABILIFY  tablet  30mg 14TK  Prescription         
1203624  ABILIFY  tablet  30mg 28TK  Prescription         
1203635  ABILIFY  tablet  30mg 49TK  Prescription         
1203646  ABILIFY  tablet  30mg 56TK  Prescription         
1203657  ABILIFY  tablet  30mg 98TK  Prescription         
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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