This is a summary of the European public assessment report (EPAR) for Flebogamma DIF. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Flebogamma DIF.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
J06BA02
ATC Item
immunoglobulins, normal human, for intravascular adm.
Pharmacotherapeutic Group
Immune sera and immunoglobulins
Active Substance (Summary)
INN / Common Names
EMA Name
Flebogamma DIF (previously Flebogammadif)
Medicine Name
Flebogamma DIF (previously Flebogammadif)
Aliases
N/A