🇪🇺 Darolutamide (BAY 1841788) in European Union

EMA authorised Darolutamide (BAY 1841788) on 27 March 2020

Marketing authorisation

EMA — authorised 27 March 2020

  • Application: EMEA/H/C/004790
  • Marketing authorisation holder: Bayer AG
  • Local brand name: Nubeqa
  • 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 androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).
  • Status: approved

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Darolutamide (BAY 1841788) in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in European Union

Frequently asked questions

Is Darolutamide (BAY 1841788) approved in European Union?

Yes. EMA authorised it on 27 March 2020.

Who is the marketing authorisation holder for Darolutamide (BAY 1841788) in European Union?

Bayer AG holds the EU marketing authorisation.