Application Nr Approved Date Route Status External Links
BLA125035 None Intramuscular None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Hepagam B [Hepatitis B Immune Globulin Intravenous (Human)] Is An Intravenous Immune Globulin Indicated For The Following: For Intravenous Or Intramuscular Administration Only Prevention Of Hepatitis B Recurrence Following Liver Transplantation In Hbsag-Positive Liver Transplant Patients ( 1.1 ). Postexposure Prophylaxis ( 1.2 ) In The Following Settings: Acute Exposure To Blood Containing Hbsag Perinatal Exposure Of Infants Born To Hbsag-Positive Mothers Sexual Exposure To Hbsag-Positive Persons Household Exposure To Persons With Acute Hbv Infection 1.1 Prevention Of Hepatitis B Recurrence Following Liver Transplant In Hbsag-Positive Liver Transplant Patients 1.2 Post-Exposure Prophylaxis Including Acute Exposure To Hbsag-Positive Blood, Plasma, Or Serum (Parenteral Exposure, Direct Mucus Membrane Contact, Oral Ingestion, Etc.), Perinatal Exposure Of Infants Born To Hbsag-Positive Mothers, Sexual Exposure To Hbsag-Positive Persons, And Household Exposure To Persons With Acute Hbv Infection.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Human Hepatitis B Virus Immune Globulin

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