| NDC Code | 70461-656-03 |
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| Package Description | 10 SYRINGE, GLASS in 1 CARTON (70461-656-03) / .5 mL in 1 SYRINGE, GLASS (70461-656-04) |
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| Product NDC | 70461-656 |
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| Product Type Name | VACCINE |
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| Proprietary Name | Flucelvax |
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| Non-Proprietary Name | Influenza A Virus A/tasmania/318/2025 Cvr-351 (h1n1) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza A Virus A/tasmania/787/2025 Cvr-388 (h3n2) Antigen (mdck Cell Derived, Propiolactone Inactivated), Influenza B Virus B/arizona/21/2025 Antigen (mdck Cell Derived, Propiolactone Inactivated) |
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| Dosage Form | INJECTION, SUSPENSION |
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| Usage | INTRAMUSCULAR |
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| Start Marketing Date | 20260701 |
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| End Marketing Date | 20270731 |
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| Marketing Category Name | BLA |
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| Application Number | BLA125408 |
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| Manufacturer | Seqirus Inc. |
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| Substance Name | INFLUENZA A VIRUS A/TASMANIA/318/2025 CVR-351 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TASMANIA/787/2025 CVR-388 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS - B/ARIZONA/21/2025 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
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| Strength | 15; 15; 15 |
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| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
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