CompanyBioMarin International Limited
ATC codeB02BD15
EU authorised2022-08-24
· 4 yr ago
Flags
Orphan
Conditional approval
EMA EPAR
Evidence dossier ↗
Roctavian CONFIRMED
valoctocogene roxaparvovec · Hemophilia
Current stage: 6 · first detected 2026-08-05
Also known as: roctavian
Nordic decisions
| Country | Body | Verdict | Date | Source |
|---|---|---|---|---|
| Norge | Beslutningsforum | Ikke lansert i Norge | 2025-01-20 | link |
Status timeline
| Date | Body | Status | Stage | Source |
|---|---|---|---|---|
| No status history. | ||||