Basic Information
EMA regulatory identification and product classification information
EMA Identifiers
Overview Summary
Comprehensive product overview and regulatory summary
Abiraterone Krka is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic).
Abiraterone Krka is used together with prednisone or prednisolone (anti-inflammatory medicines):
- when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Krka is then used in combination with a treatment called androgen deprivation therapy;
- when medical castration (using medicines to stop the production of male hormones) with androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines);
- when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work.
Abiraterone Krka contains the active substance abiraterone acetate and is a ‘generic medicine’. This means that Abiraterone Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zytiga.
Active Substances (1)
abiraterone acetate
Documents (9)
Abiraterone Krka : EPAR - Public assessment report
November 23, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Abiraterone Krka : EPAR - Procedural steps taken and scientific information after authorisation
July 6, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Abiraterone Krka
April 23, 2021
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Abiraterone Krka : EPAR - Public assessment report
November 23, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Abiraterone Krka
April 23, 2021
CHANGES_SINCE_INITIAL_AUTHORISATION
Abiraterone Krka : EPAR - Medicine overview
November 23, 2021
OVERVIEW_DOCUMENT
Abiraterone Krka : EPAR - All authorised presentations
November 23, 2021
AUTHORISED_PRESENTATIONS
Abiraterone Krka : EPAR - Product information
November 23, 2021
DRUG_PRODUCT_INFORMATION
Abiraterone Krka : EPAR - Risk-management-plan summary
November 23, 2021
RISK_MANAGEMENT_PLAN_SUMMARY
Overview Q&A (7)
Question
Other information about Abiraterone Krka
Answer
Abiraterone Krka received a marketing authorisation valid throughout the EU on 24 June 2021.
Question
How is Abiraterone Krka used?
Answer
Abiraterone Krka is available as tablets and can only be obtained with a prescription. The recommended dose is 1,000 mg taken once a day on an empty stomach. This means that the patient should wait at least 2 hours after eating before taking the medicine and must not eat for at least 1 hour after taking the medicine. If patients develop liver problems, treatment should be stopped. Treatment may be resumed at a reduced dose if liver function returns to normal.
For more information about using Abiraterone Krka, see the package leaflet or contact your doctor or pharmacist.
Question
How does Abiraterone Krka work?
Answer
The active substance in Abiraterone Krka, abiraterone acetate, is changed in the body to abiraterone which stops the body producing testosterone, a male hormone. Abiraterone does this by blocking an enzyme called CYP17 found in the testes and elsewhere in the body. Because the cancer needs a supply of testosterone to survive and grow, by reducing the production of testosterone, Abiraterone Krka may slow the growth of the prostate cancer.
Question
Why is Abiraterone Krka authorised in the EU?
Answer
The European Medicines Agency concluded that, in accordance with EU requirements, Abiraterone Krka has been shown to have comparable quality and to be bioequivalent to Zytiga. Therefore, the Agency’s view was that, as for Zytiga, the benefits of Abiraterone Krka outweigh the identified risks and it can be authorised for use in the EU.
Question
What are the benefits and risks of Abiraterone Krka?
Answer
Because Abiraterone Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine’s.
Question
What measures are being taken to ensure the safe and effective use of Abiraterone Krka?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abiraterone Krka have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Abiraterone Krka are continuously monitored. Side effects reported with Abiraterone Krka are carefully evaluated and any necessary action taken to protect patients.
Question
How has Abiraterone Krka been studied?
Answer
Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Zytiga, and do not need to be repeated for Abiraterone Krka.
As for every medicine, the company provided studies on the quality of Abiraterone Krka. The company also carried out a study that showed that it is ‘bioequivalent’ to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.