Nubeqa (darolutamide)
- Region
- 🇪🇺 EU
- Active substance
- darolutamide
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms, Castration-Resistant
- CHMP opinion
- Thu 30 Jan 2020
- EU approval
- Fri 27 Mar 2020
- Application
- EMEA/H/C/004790
- ATC
- L02BB
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.