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Arepanrix
Influenza A [H5] Monovalent Vaccine, Adjuvanted
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Arepanrix
Proper name
Influenza A [H5] Monovalent Vaccine, Adjuvanted
Licence type
351(a)
BLA number
125419
Applicant
ID Biomedical Corporation of Quebec
Center
CBER
Presentations
1
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 0.5ML | Injection | Intramuscular | Vial | Disc | November 22, 2013 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |