Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 20 September 2017

Indication(s)

Replacement therapy in adults, and children and adolescents (0-18 years) in:
- Primary immunodeficiency (PID) 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 with recurrent bacterial infections.

Immunomodulation in adults, and 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.
- Chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.

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More information

Category Value
Agency product number EMEA/H/C/000831
Orphan designation No
Date First Approved 25-04-2008
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder CSL Behring GmbH