Basic Information
Abiraterone Mylan
Regulatory Information
EMEA/H/C/005368
August 20, 2021
June 24, 2021
6
January 6, 2025
Company Information
Ireland
Damastown Industrial Park Mulhuddart Dublin 15
MYLAN PHARMACEUTICALS PRIVATE LIMITED
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
Abiraterone Mylan is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic). Abiraterone Mylan is used together with prednisone or prednisolone (anti-inflammatory medicines): - when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Mylan is then used in combination with a treatment called androgen deprivation therapy; - when medical castration (using medicines to stop the production of male hormones) with androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines); - when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work. Abiraterone Mylan contains the active substance abiraterone acetate and is a ‘generic medicine’. This means that Abiraterone Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zytiga.