Erleada

RSS

apalutamide

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

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.

This EPAR was last updated on 25/08/2022

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 monitoringAdditional 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
8
Date of issue of marketing authorisation valid throughout the European Union
14/01/2019
Contact address

Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

10/02/2022 Erleada - EMEA/H/C/004452 - II/0017

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Product information documents contain:

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).

Assessment history

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