Flebogamma DIF (previously Flebogammadif)


human normal immunoglobulin

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR) for Flebogamma DIF. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Flebogamma DIF.

This EPAR was last updated on 04/02/2022

Authorisation details

Product details
Flebogamma DIF (previously Flebogammadif)
Agency product number
Active substance
Human normal immunoglobulin
International non-proprietary name (INN) or common name
human normal immunoglobulin
Therapeutic area (MeSH)
  • Mucocutaneous Lymph Node Syndrome
  • Guillain-Barre Syndrome
  • Bone Marrow Transplantation
  • Purpura, Thrombocytopenic, Idiopathic
  • Immunologic Deficiency Syndromes
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Instituto Grifols S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

C/ Can Guasch, 2
Pol. Ind. Levante,
08150 Parets del Vallès

Product information

03/02/2022 Flebogamma DIF (previously Flebogammadif) - EMEA/H/C/000781 - N/0069

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic 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.

Immunomodulation in adults, 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.

Assessment history

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