Abiraterone Mylan (abiraterone acetate)
- Region
- 🇪🇺 EU
- Active substance
- abiraterone acetate
- Company
- Mylan Pharmaceuticals Limited
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 24 Jun 2021
- EU approval
- Fri 20 Aug 2021
- Designations
- Generic
- Application
- EMEA/H/C/005368
- ATC
- L02BX03
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Akeega Authorised ·
- 🇪🇺 Abiraterone Krka Authorised · KRKA tovarna zdravil d.d. Novo mesto
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.