Overview

Abiraterone Mylan 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 Mylan is used together with prednisone or prednisolone (anti-inflammatory medicines):

  • when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Mylan 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 Mylan contains the active substance abiraterone acetate and is a ‘generic medicine’. This means that Abiraterone Mylan contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zytiga.

Abiraterone Mylan 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 two hours after eating before taking the medicine and must not eat for at least one hour after taking the medicine. If the patient develops liver problems, treatment should be stopped. Treatment may be resumed at a reduced dose if the liver function returns to normal.

For more information about using Abiraterone Mylan, see the package leaflet or contact your doctor or pharmacist.

The active substance in Abiraterone Mylan, 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 Mylan can slow the growth of the prostate cancer.

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 Mylan.

As for every medicine, the company provided data on the quality of Abiraterone Mylan. The company also carried out studies 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.

Because Abiraterone Mylan 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.

The European Medicines Agency concluded that, in accordance with EU requirements, Abiraterone Mylan 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 Mylan outweigh the identified risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abiraterone Mylan have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Abiraterone Mylan are continuously monitored. Side effects reported with Abiraterone Mylan are carefully evaluated and any necessary action taken to protect patients.

Abiraterone Mylan received a marketing authorisation valid throughout the EU on 20 August 2021.

Abiraterone Mylan : EPAR - Medicine overview

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Abiraterone Mylan : EPAR - Risk-management-plan summary

Product information

Abiraterone Mylan : EPAR - Product information

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Latest procedure affecting product information: N/0007

05/09/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Abiraterone Mylan : EPAR - All authorised presentations

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Product details

Name of medicine
Abiraterone Mylan
Active substance
abiraterone acetate
International non-proprietary name (INN) or common name
abiraterone acetate
Therapeutic area (MeSH)
Prostatic Neoplasms
Anatomical therapeutic chemical (ATC) code
L02BX03

Pharmacotherapeutic group

  • Endocrine therapy
  • Other hormone antagonists and related agents

Therapeutic indication

Abiraterone Mylan 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.

Authorisation details

EMA product number
EMEA/H/C/005368

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.

Marketing authorisation holder
Mylan Ireland Limited

Unit 35/36 Grange Parade
Baldoyle Industrial Estate
Dublin 13
Ireland

Opinion adopted
24/06/2021
Marketing authorisation issued
20/08/2021
Revision
4

Assessment history

Abiraterone Mylan : EPAR - Procedural steps taken and scientific information after the authorisation

Abiraterone Mylan : EPAR - Public assessment report

CHMP summary of positive opinion for Abiraterone Mylan

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