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Alhemo
concizumab-mtci
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Alhemo
Proper name
concizumab-mtci
Licence type
351(a)
BLA number
761315
Applicant
Novo Nordisk Inc.
Center
CDER
Presentations
3
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 150MG/1.5ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | December 20, 2024 |
| 300MG/3ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | December 20, 2024 |
| 60MG/1.5ML (40MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | December 20, 2024 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | December 20, 1931 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |