← FDA DRUG APPROVALS

FDA BLA · BLA761315

ALHEMO

concizumab

Sponsor: NOVO NORDISK INC

APPLICATION
BLA761315
TYPE
BLA
ORIGINAL APPROVAL
2024-12-20
LATEST ACTION
2025-07-31
ROUTE
SUBCUTANEOUS, Subcutaneous
DOSAGE FORM
Injectable
MARKETING STATUS
Prescription

Products

ALHEMOPrescription
CONCIZUMAB-MTCI 150MG/1.5ML(100MG/ML) · Injectable · Subcutaneous
ALHEMOPrescription
CONCIZUMAB-MTCI 300MG/3ML(100MG/ML) · Injectable · Subcutaneous
ALHEMOPrescription
CONCIZUMAB-MTCI 60MG/1.5ML(40MG/ML) · Injectable · Subcutaneous

Approval history

2025-07-31Labeling · Supplement 3 · standard — Letter ↗AP
2025-05-02Labeling · Supplement 1 · standard — Label ↗AP
2024-12-20Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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