{"entity":{"id":"human-normal-immunoglobulin","kind":"drug","name":"Human normal immunoglobulin (IVIg)","aka":["human normal immunoglobulin (IVIg)","human normal immunoglobulin","IVIg","intravenous immunoglobulin","Privigen","Kiovig"],"tldr":"Intravenous immunoglobulin is pooled antibody from many blood donors. People with chronic lymphocytic leukaemia or myeloma whose own antibody levels have collapsed, and who keep getting bacterial infections despite antibiotics, receive it as replacement.","summary":"Human normal immunoglobulin for intravenous use is authorised in the EU as Kiovig (authorised 19 January 2006; marketing authorisation holder Takeda Manufacturing Austria AG) and Privigen (authorised 24 April 2008; CHMP opinion 21 February 2008; marketing authorisation holder CSL Behring GmbH). The replacement-therapy indications include primary immunodeficiency syndromes and, in cancer care, hypogammaglobulinaemia with recurrent bacterial infections in patients with chronic lymphocytic leukaemia in whom prophylactic antibiotics have failed, and in plateau-phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; the products also carry immunomodulation indications outside oncology.","status":"approved","asOf":"2026-09-22","links":[{"label":"EMA: Privigen (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/privigen"},{"label":"EMA: Kiovig (EPAR)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/kiovig"}],"tags":["ema-register","supportive"],"related":[],"cancers":["cll","multiple-myeloma"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":["csl","takeda"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo content wave 5 (EMA medicines register and EPAR pages)","editedOn":"2026-09-22"},"brand":"Privigen / Kiovig","modality":"Pooled human polyclonal IgG antibody preparation (intravenous immunoglobulin)","mechanism":"Replacement of antibodies in patients whose own production has failed; in cancer care, for hypogammaglobulinaemia with recurrent bacterial infections in chronic lymphocytic leukaemia after prophylactic antibiotics have failed and in plateau-phase multiple myeloma after failure to respond to pneumococcal immunisation (indication wording, EMA).","approvals":[{"region":"EU","year":2006,"indication":"Replacement therapy in hypogammaglobulinaemia with recurrent bacterial infections in CLL (after failed antibiotic prophylaxis) and plateau-phase multiple myeloma (after failed pneumococcal immunisation); primary immunodeficiency","note":"Kiovig authorised 19 Jan 2006 (Takeda); Privigen 24 Apr 2008 (CSL Behring)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/human-normal-immunoglobulin/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"multiple-myeloma","kind":"cancer","name":"Multiple myeloma","route":"/cancers/multiple-myeloma/"}],"company":[{"id":"csl","kind":"company","name":"CSL Limited","route":"/companies/csl/"},{"id":"takeda","kind":"company","name":"Takeda","route":"/companies/takeda/"}]}}