Flebogamma DIF (previously Flebogammadif)

RSS

human normal immunoglobulin

Authorised
This medicine is authorised for use in the European Union.

Overview

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 12/09/2019

Authorisation details

Product details
Name
Flebogamma DIF (previously Flebogammadif)
Agency product number
EMEA/H/C/000781
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
J06BA02
Publication details
Marketing-authorisation holder
Instituto Grifols S.A.
Revision
17
Date of issue of marketing authorisation valid throughout the European Union
23/07/2007
Contact address
Can Guasch 2
E-08150 Parets del Vallès
Barcelona
Spain

Product information

31/07/2019 Flebogamma DIF (previously Flebogammadif) - EMEA/H/C/000781 - II/0059/G

Contents

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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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