human immunoglobulin g

FDA Drug Profile — QIVIGY kthm

Drug Details

Generic Name
human immunoglobulin g
Brand Names
QIVIGY kthm
Application Number
BLA125822
Sponsor
Kedrion S.p.A.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
HUMAN IMMUNOGLOBULIN G

Indications and Usage

1 INDICATIONS AND USAGE ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). PI includes, but is not limited to, the humoral immune defect in congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies (SCID). ASCENIV (immune globulin intravenous, human – slra) is a 10% immune globulin liquid for intravenous injection, indicated for the treatment of primary humoral immunodeficiency (PI) in adults and adolescents (12 to 17 years of age). [1]