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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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ABIRATERONE SANDOZ
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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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Strength:
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1000mg
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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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 (last updated July 6, 2021)
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Package information leaflet (PIL):
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EST (last updated July 6, 2021)
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Labelling:
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(last updated October 25, 2023)
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Indication:
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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 docetaxel-based chemotherapy regimen.
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Safety features:
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Yes
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Marketing authorization holder:
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Sandoz Pharmaceuticals d.d.
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Marketing authorization number:
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1034821
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Marketing authorization issued on:
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July 6, 2021
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Marketing authorization expires on:
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July 6, 2026
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Marketing authorization procedure type:
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Decentralised
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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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1814701
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ABIRATERONE SANDOZ
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film-coated tablet
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1000mg 28TK
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Prescription
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1814712
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ABIRATERONE SANDOZ
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film-coated tablet
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1000mg 30TK
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Prescription
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23.01.2023
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1814723
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ABIRATERONE SANDOZ
|
film-coated tablet
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1000mg 60TK
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Prescription
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1814734
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ABIRATERONE SANDOZ
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film-coated tablet
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1000mg 84TK
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Prescription
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1845187
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ABIRATERONE SANDOZ
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film-coated tablet
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1000mg 56TK
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Prescription
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1845198
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ABIRATERONE SANDOZ
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film-coated tablet
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1000mg 90TK
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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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