Abiraterone Mylan

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abiraterone acetate

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/08/2021

Authorisation details

Product details
Name
Abiraterone Mylan
Agency product number
EMEA/H/C/005368
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
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Mylan Ireland Limited
Date of issue of marketing authorisation valid throughout the European Union
20/08/2021
Contact address

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

Product information

20/08/2021 Abiraterone Mylan - EMEA/H/C/005368 -

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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.

Assessment history

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