Privigen

RSS

human normal immunoglobulin (IVIg)

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

Overview

Privigen is a medicine used to support the immune system (the body’s natural defences) in two main groups of patients:

  • Patients who are at risk of infection because they do not have enough antibodies (also called immunoglobulins, proteins in the blood that help the body to fight disease). These can be people who are born with a lack of antibodies (primary immunodeficiency syndrome, PID). These also include people who have developed a lack of antibodies after birth (secondary immunodeficiency syndrome, SID), who have low levels of certain antibodies (called IgG) and who suffer from infections that are severe, keep coming back, and are not cured by medicines used to treat infections.

  • Patients with certain immune disorders. These comprise patients with primary immune thrombocytopenia (ITP), who do not have enough platelets (components in the blood that help it to clot) and who are at high risk of bleeding; patients with Guillain-Barré syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), inflammatory disorders of the nerves that result in muscle weakness and numbness; patients with Kawasaki disease, a disease mainly seen in children which causes inflammation of blood vessels; and patients with multifocal motor neuropathy (MMN), nerve damage which causes weakness of the arms and legs.

    The medicine contains the active substance human normal immunoglobulin.

This EPAR was last updated on 22/08/2019

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
24
Date of issue of marketing authorisation valid throughout the European Union
24/04/2008
Contact address
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany

Product information

16/05/2019 Privigen - EMEA/H/C/000831 - II/0147

Contents

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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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