This medicine is authorised for use in the European Union.


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).

It is also used when the cancer has spread to other parts of the body but responds to treatment that lowers testosterone levels (hormone sensitive). It is used in combination with docetaxel (another cancer medicine) and a treatment called androgen deprivation therapy (treatment to lower male sex hormones).

Nubeqa contains the active substance darolutamide.

This EPAR was last updated on 20/03/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
Prostatic Neoplasms, Castration-Resistant
Anatomical therapeutic chemical (ATC) code
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
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Kaiser-Wilhelm-Allee 1
51373 Leverkusen

Product information

27/02/2023 Nubeqa - EMEA/H/C/004790 - II/0009

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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

NUBEQA is indicated for the treatment of adult men with
- non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1).
- metastatic hormone sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

Assessment history

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