human normal immunoglobulin
Kiovig is a medicine used to support the immune system (the body’s natural defences) in two main groups of patients:
- Patients at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease). These can be people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID). These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections;
- Patients with certain immune disorders. These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs.
The medicine contains the active substance human normal immunoglobulin.
Kiovig : EPAR - Medicine overview (PDF/82.52 KB)
First published: 13/06/2008
Last updated: 24/04/2019
|Agency product number||
human normal immunoglobulin (IVIg)
|International non-proprietary name (INN) or common name||
human normal immunoglobulin
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
|Date of issue of marketing authorisation valid throughout the European Union||
17/07/2019 Kiovig - EMEA/H/C/000628 - N/0093
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Immune sera and immunoglobulins
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);
- congenital AIDS and 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;
- multifocal motor neuropathy (MMN).