Nubeqa

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darolutamide

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

Overview

Nubeqa is a medicine used to treat men with prostate cancer.

It is used when the cancer is castration-resistant (worsens despite treatment to lower testosterone levels, including surgical removal of the testes) and is at high risk of metastasis (spreading to other parts of the body).

Nubeqa contains the active substance darolutamide.

This EPAR was last updated on 28/05/2020

Authorisation details

Product details
Name
Nubeqa
Agency product number
EMEA/H/C/004790
Active substance
darolutamide
International non-proprietary name (INN) or common name
darolutamide
Therapeutic area (MeSH)
Prostatic Neoplasms, Castration-Resistant
Anatomical therapeutic chemical (ATC) code
L02BB
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
Bayer AG
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
27/03/2020
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen
Germany

Product information

12/05/2020 Nubeqa - EMEA/H/C/004790 - IB/0001

Contents

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Pharmacotherapeutic group

Endocrine therapy

Therapeutic indication

Nubeqa is indicated for the treatment of adult men with non metastatic castration resistant prostate cancer (nmCRPC) who are at risk of developing metastatic disease.

Assessment history

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