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mresvia
Respiratory Syncytial Virus Vaccine
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
mresvia
Proper name
Respiratory Syncytial Virus Vaccine
Licence type
351(a)
BLA number
125796
Applicant
ModernaTX, Inc.
Center
CBER
Presentations
1
First licensure
May 31, 2024
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 50UG/.5ML | For Injection | Intramuscular | Pre-Filled Syringe | Rx | May 31, 2024 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |