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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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1856101
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Name of medicinal product:
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ABIRATERONE KRKA
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Active substances:
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ATC code:
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L02BX03
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Dosage form:
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film-coated tablet
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Route of administration:
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oral use
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Strengh:
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500mg
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Amount in package:
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56TK
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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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Abiraterone Krka is indicated with prednisone or prednisolone for:
- the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer
(mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section
5.1)
- the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are
asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom
chemotherapy is not yet clinically indicated (see section 5.1)
- the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxelbased chemotherapy regimen.
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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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KRKA d.d. Novo mesto
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Marketing authorization number:
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EU/1/21/1553
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Marketing authorization issued on:
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June 24, 2021
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Marketing authorization expires on:
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June 28, 2026
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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:
August 11, 2021
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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