Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) (UNII: V8PC20UBCN) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:WLSRJ8JC6S)
Catalent Belgium SA
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 ANTIGEN HEMAGGLUTININ ANTIGEN - UNII:WLSRJ8JC6S)
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0.5 mL
Biologic Licensing Application
FLUVIRIN- A/SINGAPORE/GP1908/2015 IVR-180 (AN A/MICHIGAN/45/2015 (H1N1)PDM09-LIKE VIRUS, A/HONG KONG/4801/2014, NYMC X-263B (H3N2) (AN A/HONG KONG/4801/2014-LIKE VIRUS), AND B/BRISBANE/60/2008, WILD TYPE (A B/BRISBANE/60/2008-LIKE VIRUS) INJECTION, SUSPENSION CATALENT BELGIUM SA ---------- THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUVIRIN (INFLUENZA VIRUS VACCINE) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUVIRIN . FLUVIRIN (INFLUENZA VIRUS VACCINE) SUSPENSION FOR INTRAMUSCULAR INJECTION 2017-2018 FORMULA INITIAL U.S. APPROVAL: 1988 PRINCIPAL DISPLAY PANEL - FLUVIRIN INJECTION PREFILLED SYRINGES CARTON LABEL SEQIRUS ™ 10 x 0.5 mL pre-filled syringes For four years of age and older Rx Only INFLUENZA VIRUS VACCINE FLUVIRIN 2017 - 2018 FORMULA ® ® ® ® PRINCIPAL DISPLAY PANEL - FLUVIRIN INJECTION PREFILLED SYRINGES LABEL 0.5 ML US LICENSE NO. 2055 INFLUENZA VIRUS VACCINE FLUVIRIN 2017 - 2018 FORMULA ® FLUVIRIN a/singapore/gp1908/2015 ivr-180 (an a/michigan/4 5/2015 (h1n1)pdm09-like virus, a/hong kong/4 801/2014 , nymc x-263b (h3n2) (an a/hong kong/4 801/2014 -like virus), and b/brisbane/60/2008, wild type (a b/brisbane/60/2008- like virus) injection, suspension PRODUCT INFORMATION PRODUCT T YPE VACCINE ITE M CODE (SOURCE ) NDC:438 35-0 0 20 ROUTE OF ADMINISTRATION INTRAMUSCULAR ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH INFLUENZA A VIRUS A/SINGAPO RE/GP19 0 8 /2 0 15 IVR-18 0 ( H1N1) ANTIGEN ( PRO PIO LACTO NE INACTIVATED) (UNII: V8 PC20 UBCN) (INFLUENZA A VIRUS A/SINGAPORE/GP19 0 8 /20 15 IVR-18 0 (H1N1) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:WLSRJ8 JC6 S) INFLUENZA A VIRUS A/SINGAPORE/GP19 0 8 /20 15 IVR- 18 0 (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) 15 ug in 0 .5 mL INFLUENZA A VIRUS A/HO NG KO NG/4 8 0 1/2 0 14 X-2 6 3 B ( H3 N2 ) ANTIGEN ( PRO PIO LACTO NE INACTIVATED) (UNII: 3DZY3Q314E) (INFLUENZA A VIRUS A/HONG KONG/48 0 1/20 14 X-26 3B (H3N2) HEMAGGLUTININ ANTIGEN (PROPIOLACTONE INACTIVATED) - UNII:C2C4DA Læs hele dokumentet