| NDC Code | 63851-612-01 |
|---|
| Package Description | 10 SYRINGE, GLASS in 1 CARTON (63851-612-01) > .5 mL in 1 SYRINGE, GLASS (63851-612-11) |
|---|
| Product NDC | 63851-612 |
|---|
| Product Type Name | VACCINE |
|---|
| Proprietary Name | Flucelvax |
|---|
| 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 |
|---|
| Usage | INTRAMUSCULAR |
|---|
| Start Marketing Date | 20130830 |
|---|
| Marketing Category Name | BLA |
|---|
| Application Number | BLA125408 |
|---|
| Manufacturer | 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) |
|---|
| Strength | 15; 15; 15 |
|---|
| Strength Unit | ug/.5mL; ug/.5mL; ug/.5mL |
|---|