Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

EMA Recommends Granting Marketing Authorisation for Generic Abiraterone Acetate

Abiraterone KRKA is a generic of Zytiga, which has been authorised in the EU since 2011
04 May 2021
Anticancer agents & Biologic therapy;  Genitourinary cancers

On 22 April 2021, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Abiraterone KRKA (abiraterone acetate), intended for the treatment of metastatic prostate cancer.

The applicant for this medicinal product is KRKA, d.d., Novo mesto.

Abiraterone KRKA will be available as 500 mg film-coated tablet. The active substance of Abiraterone KRKA is abiraterone acetate, a hormone antagonist (ATC code: L02BX03) that inhibits the production of androgens in the testes, adrenal glands and prostatic tumour tissues.

Abiraterone KRKA is a generic of Zytiga, which has been authorised in the EU since 5 September 2011. Studies have demonstrated the satisfactory quality of Abiraterone KRKA, and its bioequivalence to the reference product Zytiga.

The full indication is: Abiraterone KRKA is indicated with prednisone or prednisolone for:

  • the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer 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 ADT 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.

Abiraterone KRKA should be prescribed by an appropriate healthcare professional.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings