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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)

Navigation: NDC > Supplier starting with: N > NOVARTIS VACCINES AND DIAGNOSTICS GMBH
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:
DEA Schedule: