Zytiga (abiraterone)
- Region
- 🇪🇺 EU
- Active substance
- abiraterone
- Company
- Janssen-Cilag International
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 21 Jul 2011
- EU approval
- Mon 05 Sep 2011
- Designations
- Accelerated assessment
- Application
- EMEA/H/C/002321
- ATC
- L02BX03
- Official record
- www.ema.europa.eu
Indication
Zytiga is indicated with prednisone or prednisolone for: the treatment of metastatic castration resistant prostate cancer 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 metastatic castration resistant prostate cancer 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
- 🇪🇺 Abiraterone Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Abiraterone Accord Authorised · Accord Healthcare S.L.U.
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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.