Vyhledat léčivý přípravek pro vzácné onemocnění
Marketing authorisation without orphan designation - Europe
- Obchodní název: KIOVIG
- ATC skupina : J06BA02
- EUGT kód: EU/1/05/329/...
- Datum obdržení rozhodnutí: 19/01/2006
- Držitel licence: BAXTER AG
- Veřejná hodnotící zpráva Evropské lékové agentury
Terapeutická indikace
*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 Barr syndrome,
- Kawasaki disease,
- Multifocal Motor Neuropathy (MMN).
Seznam onemocnění
- Evans syndrome
- Guillain-Barr syndrome
- Immune thrombocytopenia
- Immunodeficiency predominantly affecting antibody production
- Kawasaki disease
- Multifocal motor neuropathy