Flucelvax - INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)
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Field |
Value |
NDC Code: |
63851-612 |
Proprietary Name: |
Flucelvax |
Suffix: |
|
Non-Proprietary Name: |
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Dosage Form: |
INJECTION, SUSPENSION |
Method: |
INTRAMUSCULAR |
Original Marketing Date: |
30-08-2013 |
Category Name: |
BLA |
Application Number: |
BLA125408 |
Labeler: |
NOVARTIS VACCINES AND DIAGNOSTICS GMBH |
Substance Name: |
INFLUENZA A VIRUS A/BRISBANE/10/2010 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/TEXAS/50/2012 X-223A (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) |
Active Numerator Strength: |
15; 15; 15 |
Active Ingredient Unit: |
ug/.5mL; ug/.5mL; ug/.5mL |
Pharm Classes: |
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DEA Schedule: |
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