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Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1203770
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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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orodispersible tablet
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Route of administration:
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oral use
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Strengh:
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30mg
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Amount in package:
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49TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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Additional information:
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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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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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Last imported to Estonia:
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Never imported to Estonia
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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 20, 2005
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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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Reference price:
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Under reference price:
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Reference price of daily dose:
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Entry/Changing date:
September 13, 2018
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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