Abiraterone Accord

abiraterone

Table of contents

Opinion

On 25 February 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Abiraterone Accord, intended for the treatment of metastatic prostate cancer. The applicant for this medicinal product is Accord Healthcare S.L.U.

Abiraterone Accord will be available as 250-mg tablet and 500-mg film-coated tablet. The active substance of Abiraterone Accord is abiraterone (as abiraterone acetate), a hormone antagonist (ATC code: L02BX03) that inhibits the production of androgens in the testes, adrenal glands and prostatic tumour tissues.

Abiraterone Accord is a generic of Zytiga, which has been authorised in the EU since 05/09/2011. Studies have demonstrated the satisfactory quality of Abiraterone Accord, and its bioequivalence to the reference product Zytiga. A question and answer document on generic medicines can be found here.

The full indication is:

Abiraterone Accord 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.

Abiraterone Accord 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 (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Abiraterone Accord
Agency product number
EMEA/H/C/005408
International non-proprietary name (INN) or common name
  • abiraterone
Active substance
  • abiraterone acetate
Therapeutic area
Prostatic Neoplasms
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
25/02/2021
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

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