Result card

  • CUR19: What is the marketing authorisation status of intravenous immunoglobulins (IVIG)?
English

What is the marketing authorisation status of intravenous immunoglobulins (IVIG)?

Authors: Antonio Migliore, Tapani Keranen, Sinikka Sihvo

Internal reviewers: Kristian Lampe

Immunoglobulins (IVIG) are authorised in Europe as {Appendix CUR-3}:

Replacement therapy in adults, and children and adolescents (0-18 years) in the following conditions:

  • Primary immunodeficiency syndromes with impaired antibody production;
  • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed;
  • Hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation;
  • Hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation (HSCT);
  • Congenital AIDS and recurrent bacterial infections;

Immunomodulation in adults, and children and adolescents (0-18 years) in the following conditions:

  • 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;
  • Multifocal Motor Neuropathy (MMN).
Critical
Completely
Migliore A et al. Result Card CUR19 In: Migliore A et al. Health Problem and Current Use of the Technology In: Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 31 October 2020]. Available from: http://corehta.info/ViewCover.aspx?id=267