Application 761428

Type
BLA
Sponsor
NOVO NORDISK INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALHEMOCONCIZUMABSOLUTION; INJECTION60MG/1.5ML (40MG/ML)NoNo
002ALHEMOCONCIZUMABSOLUTION; INJECTION150MG/1.5ML (100MG/ML)NoNo
003ALHEMOCONCIZUMABSOLUTION; INJECTION300MG/3ML (100MG/ML)NoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83028ORIG 2025-08-01
83027ORIG 2025-08-01
83023ORIG 2025-08-01