Anpheros Search · Treatment

Abiraterone

Also known as: abiraterone acetate · Zytiga · Abiraterone Accord · Abiraterone Krka · Abiraterone Mylan

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In short

In the European Union, Zytiga is indicated in combination with prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after androgen deprivation therapy has failed and chemotherapy is not yet clinically indicated, or whose disease has progressed on or after a docetaxel-based chemotherapy regimen. In the United States, abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. The cited sources list abiraterone as having an approved use for unspecified malignant neoplasms of the prostate.

From: Source: European Medicines Agency (EMA), Zytiga — EPAR, 18/10/2024. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration. · Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
1100072 abiraterone
EMA
EMEA/H/C/002321, EMEA/H/C/005408, EMEA/H/C/005649, EMEA/H/C/005368

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) ABIRATERONE ACETATE

1 INDICATIONS AND USAGE Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). (1)

Data provided by the U.S. Food and Drug Administration.

Document date: 20260811 · Official document →

EMA (EU) Zytiga

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.

Source: European Medicines Agency (EMA), Zytiga — EPAR, 18/10/2024. © European Medicines Agency.

Document date: 18/10/2024 · Official document →

Related terms in the cited sources

Has an official indication for

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What people report

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External resources

Questions

What is Abiraterone approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Zytiga — EPAR, 18/10/2024. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Zytiga — EPAR, 18/10/2024. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →