AFLURIA is a Intramuscular Injection, Suspension in the Vaccine category. It is labeled and distributed by Seqirus Pty Ltd. The primary component is Iinfluenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated); Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated); Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated).
Product ID | 33332-118_c5baabbc-73bd-4d58-9ced-d6611b9d884f |
NDC | 33332-118 |
Product Type | Vaccine |
Proprietary Name | AFLURIA |
Generic Name | Influenza A Virus A/singapore/gp1908/2015 Ivr-180a (h1n1) Antigen (propiolactone Inactivated), Influenza A Virus A/singapore/infimh-16-0019/2016 Ivr-186 (h3n2) Antigen (propiolactone Inactivated) And Influenza B Virus B/maryland/15/2016 Antigen (propiolactone Inactivated) |
Dosage Form | Injection, Suspension |
Route of Administration | INTRAMUSCULAR |
Marketing Start Date | 2011-07-15 |
Marketing Category | BLA / BLA |
Application Number | BLA125254 |
Labeler Name | Seqirus Pty Ltd |
Substance Name | IINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED); INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
Active Ingredient Strength | 15 ug/.5mL; ug/.5mL; ug/.5mL |
NDC Exclude Flag | N |
Listing Certified Through | 2019-12-31 |
Marketing Start Date | 2011-07-15 |
NDC Exclude Flag | N |
Sample Package? | N |
Marketing Category | BLA |
Application Number | BLA125254 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2011-07-15 |
Marketing End Date | 2019-11-01 |
Marketing Category | BLA |
Application Number | BLA125254 |
Product Type | VACCINE |
Billing Unit | ML |
Marketing Start Date | 2011-07-15 |
Marketing End Date | 2019-11-01 |
Ingredient | Strength |
---|---|
IINFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) | 15 ug/.5mL |
NDC | Brand Name | Generic Name |
---|---|---|
33332-015 | AFLURIA | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) |
33332-018 | AFLURIA | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
33332-115 | AFLURIA | INFLUENZA A VIRUS A/CALIFORNIA/7/2009 X-181 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/TEXAS/50/2012 X-223 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED), and INFLUENZA B VIRUS B/MASSACHUSETTS/2/2012 BX-51B ANTIGEN (PROPIOLACTONE INACTIVATED) |
33332-118 | AFLURIA | INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED), INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 IVR-186 (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) AND INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (PROPIOLACTONE INACTIVATED) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AFLURIA 79004750 3057916 Live/Registered |
CSL Limited 2004-07-13 |