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Marketing authorisation without orphan designation - Europe
- Nazwa handlowa (Nazwy handlowe): KIOVIG
- ATC code : J06BA02
- EU Number: EU/1/05/329/...
- MA date : 19/01/2006
- MA holder: BAXTER AG
- European Public Assessment Report
Therapeutic indication
*Replacement therapy in adults, and children and adolescents (0-18 years) in:
- 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).
*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,
- Multifocal Motor Neuropathy (MMN).
Lista chorób
- Evans syndrome
- Guillain-Barré syndrome
- Immune thrombocytopenia
- Immunodeficiency predominantly affecting antibody production
- Kawasaki disease
- Multifocal motor neuropathy