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Product class:
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Medicinal product with marketing authorization
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Medicinal product class:
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Human medicine
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Name of medicinal product:
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ABILIFY
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Active substances:
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ATC code:
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N05AX12
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Dosage form:
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tablet
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Strength:
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30mg
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Legal status for supply*:
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Subject to medicinal prescription
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Summary of product characteristics (SPC):
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Package information leaflet (PIL):
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EST
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Labelling:
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Indication:
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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).
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Safety features:
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Yes
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Marketing authorization holder:
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Otsuka Pharmaceutical Netherlands B.V.
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Marketing authorization number:
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EU/1/04/276
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Marketing authorization issued on:
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June 4, 2004
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Assessment report:
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Package code
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Name of medicinal product
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Dosage form
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Package
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Legal status
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Reimbursements
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Reference price
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Last imported
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PƤritolumaa
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Additional information
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1203613
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ABILIFY
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tablet
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30mg 14TK
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Prescription
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1203624
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ABILIFY
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tablet
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30mg 28TK
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Prescription
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1203635
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ABILIFY
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tablet
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30mg 49TK
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Prescription
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1203646
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ABILIFY
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tablet
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30mg 56TK
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Prescription
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1203657
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ABILIFY
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tablet
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30mg 98TK
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Prescription
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Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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