Abiraterone Mylan
abiraterone acetate
Table of contents
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.
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Abiraterone Mylan : EPAR - Medicine overview (PDF/166.84 KB)
First published: 26/08/2021
EMA/395446/2021 -
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Abiraterone Mylan : EPAR - Risk-management-plan summary (PDF/109.04 KB)
First published: 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
|
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. |
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Mylan Ireland Limited
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
20/08/2021
|
| Contact address |
Unit 35/36 Grange Parade |
Product information
15/06/2022 Abiraterone Mylan - EMEA/H/C/005368 - N/0003
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Endocrine therapy
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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.