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 and is at high risk of spreading to other parts of the body.

Erleada contains the active substance apalutamide.

This EPAR was last updated on 19/03/2019

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
Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.
Date of issue of marketing authorisation valid throughout the European Union
14/01/2019
Contact address
Turnhoutseweg 30
B-2340 Beerse
Belgium

Product information

Erleada - EMEA/H/C/004452 -

Contents

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Pharmacotherapeutic group

ENDOCRINE THERAPY

Therapeutic indication

Erleada is indicated in adult men for the treatment of non metastatic castration resistant prostate cancer (NM CRPC) who are at high risk of developing metastatic disease.

Assessment history

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