Product class: Authorized package
Medicinal product class: For human use
Package code: 1203613
Name of medicinal product: ABILIFY
Active substances:
Aripiprazole
Estonian, English, Latin
ATC code: N05AX12
Dosage form: tablet
Route of administration: oral use
Strengh: 30mg
Amount in package: 14TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
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
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/1/04/276 
Marketing authorization issued on: 04 June 2004 
Marketing authorization expires on: Unlimited 
Marketing authorization procedure type: Centralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Entry/Changing date: 13 September 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription