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🇪🇺EU · EMAAuthorisedATC: J06BA02

Flebogamma DIF (previously Flebogammadif)(human normal immunoglobulin)

Mucocutaneous Lymph Node Syndrome;Guillain-Barre Syndrome;Bone Marrow Transplantation;Purpura, Thrombocytopenic, Idiopathic;Immunologic Deficiency Syndromes

Marketing Authorisation Holder: Instituto Grifols S.A.

EMA Authorisation: 23/07/2007

INN: human normal immunoglobulin

Indication

Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, children and adolescents (0-18 years) in: primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.