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ENSPRYNG (Roche Products Pty Ltd)
Product name
ENSPRYNG
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
219 working days (255)
Active ingredients
satralizumab
Registration type
NCE/NBE
Indication
ENSPRYNG (solution for injection) is indicated as monotherapy or in combination with immunosuppressive therapy (IST) for the treatment of adults with neuromyelitis optica spectrum disorders (NMOSD) who have an anti-aquaporin 4 antibody (AQP4)-IgG (also termed NMO-IgG) positive status.