Enzalutamide Accordpharma (enzalutamide)
Generic
- Region
- 🇪🇺 EU
- Active substance
- enzalutamide
- Company
- Accord Healthcare
- Status
- Authorised
- Therapeutic area
- Prostatic Neoplasms
- CHMP opinion
- Thu 13 Nov 2025
- Designations
- Generic
- Application
- EMEA/H/C/006612
- ATC
- L02BB04
- Official record
- www.ema.europa.eu
Indication
Treatment of prostate cancer.
Regulatory milestones
Mon 19 Jan 2026🇪🇺 Expected EC decisionestimate
Enzalutamide Accordpharma (enzalutamide): expected EC decision
Estimated as CHMP opinion (2025-11-13) + 67 days, the standard Commission decision period. Not an official date. · Accord Healthcare · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Enzalutamide Accordpharma (enzalutamide): CHMP positive opinion
Accord Healthcare; Generic · source
Same substance in other markets
- 🇪🇺 Enzalutamide Viatris Authorised · Viatris Limited
- 🇪🇺 Xtandi Authorised · Astellas Pharma Europe B.V.
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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.