Enzalutamide Viatris (enzalutamide)
- Region
- 🇪🇺 EU
- Active substance
- enzalutamide
- Company
- Viatris Limited
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 27 Jun 2024
- EU approval
- Thu 22 Aug 2024
- Designations
- Generic
- Application
- EMEA/H/C/006299
- ATC
- L02BB04
- Official record
- www.ema.europa.eu
Indication
Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Xtandi Authorised · Astellas Pharma Europe B.V.
- 🇪🇺 Enzalutamide Accordpharma Authorised · Accord Healthcare
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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.