Abiraterone Accord
abiraterone
Table of contents
Overview
Abiraterone Accord 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 Accord is used together with prednisone or prednisolone (anti-inflammatory medicines):
- when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Accord 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 an 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 Accord contains the active substance abiraterone acetate and is a ‘generic medicine’. This means that Abiraterone Accord 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 Accord : EPAR - Medicine overview (PDF/140.84 KB) (new)
First published: 05/05/2021
EMA/163793/2021 -
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Abiraterone Accord : EPAR - Risk-management-plan summary (PDF/175.61 KB) (new)
First published: 05/05/2021
Authorisation details
| Product details | |
|---|---|
| Name |
Abiraterone Accord
|
| Agency product number |
EMEA/H/C/005408
|
| Active substance |
abiraterone acetate
|
| International non-proprietary name (INN) or common name |
abiraterone
|
| 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 |
Accord Healthcare S.L.U.
|
| Date of issue of marketing authorisation valid throughout the European Union |
26/04/2021
|
| Contact address |
World Trade Center |
Product information
26/04/2021 Abiraterone Accord - EMEA/H/C/005408 -
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Pharmacotherapeutic group
Endocrine therapy
Therapeutic indication
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.