Privigen

RSS

human normal immunoglobulin (IVIg)

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

Overview

This is a summary of the European public assessment report (EPAR) for Privigen. 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 Privigen.

This EPAR was last updated on 03/04/2018

Authorisation details

Product details
Name
Privigen
Agency product number
EMEA/H/C/000831
Active substance
human normal immunoglobulin (IVIg)
International non-proprietary name (INN) or common name
human normal immunoglobulin (IVIg)
Therapeutic area (MeSH)
  • Purpura, Thrombocytopenic, Idiopathic
  • Bone Marrow Transplantation
  • Immunologic Deficiency Syndromes
  • Guillain-Barre Syndrome
  • Mucocutaneous Lymph Node Syndrome
Anatomical therapeutic chemical (ATC) code
J06BA02
Publication details
Marketing-authorisation holder
CSL Behring GmbH
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
25/04/2008
Contact address
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany

Product information

28/11/2017 Privigen - EMEA/H/C/000831 - R/0122

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

IMMUNE SERA AND IMMUNOGLOBULINS

Therapeutic indication

Replacement therapy in adults, and children and adolescents (0-18 years) in:

  • primary immunodeficiency (PID) 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 with recurrent bacterial infections.

Immunomodulation in adults, and 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;
  • chronic inflammatory demyelinating polyneuropathy (CIDP). Only limited experience is available of use of intravenous immunoglobulins in children with CIDP.

Assessment history

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