Prognia
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🇪🇺EU · EMAAuthorisedATC: L02BX03

Abiraterone Mylan(abiraterone acetate)

Prostatic Neoplasms

Marketing Authorisation Holder: Mylan Pharmaceuticals Limited

EMA Authorisation: 20/08/2021

INN: abiraterone acetate

Indication

Abiraterone Mylan 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). 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. the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.