Home Applications 761315 Application 761315
Type BLA
Sponsor NOVO NORDISK INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761315 Alhemo concizumab-mtci 351(a) Rx 2026-07-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ALHEMO CONCIZUMAB-MTCI Injectable; Subcutaneous 60MG/1.5ML(40MG/ML) No No 002 ALHEMO CONCIZUMAB-MTCI Injectable; Subcutaneous 150MG/1.5ML(100MG/ML) No No 003 ALHEMO CONCIZUMAB-MTCI Injectable; Subcutaneous 300MG/3ML(100MG/ML) No No
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Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alhemo CONCIZUMAB Novo Nordisk 156f6404-1f6f-417f-bcf8-f07a27a82cc1 2025-07-01 Warnings, Adverse reactions Exact identifier application number: BLA761315
Documents# Document, Submission type, Date table Document Submission type Date 83030 SUPPL 2025-08-01 83029 SUPPL 2025-08-01 83021 SUPPL 2025-08-01 82261 SUPPL 2025-05-02 80919 ORIG 2025-02-05 80745 ORIG 2024-12-27 80676 ORIG 2024-12-20