APPLICATION
BLA761428
TYPE
BLA
ORIGINAL APPROVAL
2025-07-31
LATEST ACTION
2025-07-31
ROUTE
INJECTION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ALHEMOPrescription
CONCIZUMAB 300MG/3ML (100MG/ML) · SOLUTION · INJECTION
ALHEMOPrescription
CONCIZUMAB 60MG/1.5ML (40MG/ML) · SOLUTION · INJECTION
ALHEMOPrescription
CONCIZUMAB 150MG/1.5ML (100MG/ML) · SOLUTION · INJECTION
Approval history
2025-07-31Type 9 - New indication submitted as distinct BLA, consolidated · Original · standard — Letter ↗AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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