Erleada
apalutamide
Table of contents
Overview
Erleada is a cancer medicine used to treat men with cancer of the prostate (a gland of the male reproductive system).
It is used when the cancer is not responding to treatments that lower testosterone levels (castration resistant) and is at high risk of spreading to other parts of the body. It is also used when the cancer has spread to other parts of the body (metastatic) but responds to treatment that lowers testosterone levels (hormone sensitive). Erleada is used in combination with a treatment called androgen deprivation therapy.
Erleada contains the active substance apalutamide.
-
List item
Erleada : EPAR - Medicine overview (PDF/122.39 KB)
First published: 19/03/2019
EMA/810516/2018 -
-
List item
Erleada : EPAR - Risk-management-plan summary (PDF/114.4 KB)
First published: 19/03/2019
Last updated: 23/06/2022
Authorisation details
Product details | |
---|---|
Name |
Erleada
|
Agency product number |
EMEA/H/C/004452
|
Active substance |
apalutamide
|
International non-proprietary name (INN) or common name |
apalutamide
|
Therapeutic area (MeSH) |
Prostatic Neoplasms
|
Anatomical therapeutic chemical (ATC) code |
L02BB05
|
Additional monitoring |
This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. |
Publication details | |
---|---|
Marketing-authorisation holder |
Janssen-Cilag International NV
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
14/01/2019
|
Contact address |
Turnhoutseweg 30 |
Product information
09/12/2022 Erleada - EMEA/H/C/004452 - PSUSA/00010745/202202
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
Endocrine therapy
Therapeutic indication
Erleada is indicated:
- in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.
- in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).