🇪🇺 IGI, 10% in European Union

EMA authorised IGI, 10% on 19 January 2006

Marketing authorisation

EMA — authorised 19 January 2006

• Application: EMEA/H/C/000628
• Marketing authorisation holder: Takeda Manufacturing Austria AG
• Local brand name: Kiovig
• 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); congenital AIDS and recurrent bacterial i
• Status: approved

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Frequently asked questions

Is IGI, 10% approved in European Union?

Yes. EMA authorised it on 19 January 2006.

Who is the marketing authorisation holder for IGI, 10% in European Union?

Takeda Manufacturing Austria AG holds the EU marketing authorisation.