Erleada (apalutamide)
- Region
- 🇪🇺 EU
- Active substance
- apalutamide
- Company
- Janssen-Cilag International NV
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 15 Nov 2018
- EU approval
- Mon 14 Jan 2019
- Application
- EMEA/H/C/004452
- ATC
- L02BB05
- Official record
- www.ema.europa.eu
Indication
Erleada is indicated: in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
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.