🇪🇺 Vivaglobin in European Union

EMA authorised Vivaglobin on 23 July 2007

Marketing authorisations

EMA — authorised 23 July 2007

  • Application: EMEA/H/C/000781
  • Marketing authorisation holder: Instituto Grifols S.A.
  • Local brand name: Flebogamma DIF (previously Flebogammadif)
  • Indication: Replacement therapy in adults, children and adolescents (0-18 years) in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic luekaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau-phase-multiple-myeloma patients who failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogenic haematopoietic-stem-cell transplantation (HSCT); congenital AIDS with recurrent bacterial infections
  • Status: approved

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EMA — authorised 2 May 2025

  • Application: EMEA/H/C/006423
  • Marketing authorisation holder: Takeda Manufacturing Austria AG
  • Local brand name: Deqsiga
  • Indication: Replacement therapy in adults, children and adolescents (0 to 18 years) in: - Primary immunodeficiency syndromes (PID) with impaired antibody production.  - Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of < 4 g/L.*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccinesImmunomodulation in adults, children and adolescents (0 to 18 years) in: -
  • Status: approved

The European Medicines Agency (EMA) granted marketing authorisation for Vivaglobin, also known as Deqsiga, on 2 May 2025. This authorisation allows the treatment of adults, children, and adolescents with primary immunodeficiency syndromes, secondary immunodeficiencies, and certain autoimmune conditions. Vivaglobin is used as replacement therapy to improve antibody production and as immunomodulation to correct platelet counts, manage autoimmune diseases, and treat neurological conditions.

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Vivaglobin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in European Union

Frequently asked questions

Is Vivaglobin approved in European Union?

Yes. EMA authorised it on 23 July 2007; EMA authorised it on 2 May 2025.

Who is the marketing authorisation holder for Vivaglobin in European Union?

Instituto Grifols S.A. holds the EU marketing authorisation.