Hizentra

RSS

human normal immunoglobulin (SCIg)

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

Overview

An overview of Hizentra and why it is authorised in the EU

Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins. It is used to treat the following conditions:

  • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
  • low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections;
  • low levels of antibodies in the blood in patients before or after allogeneic haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);
  • chronic inflammatory demyelinating polyneuropathy (CIDP). In this rare disease, the immune system (the body’s defence system) works abnormally and destroys the protective covering over the nerves.

Hizentra contains the active substance human normal immunoglobulin.

This EPAR was last updated on 30/04/2018

Authorisation details

Product details
Name
Hizentra
Agency product number
EMEA/H/C/002127
Active substance
human normal immunoglobulin (SCIg)
International non-proprietary name (INN) or common name
human normal immunoglobulin (SCIg)
Therapeutic area (MeSH)
Immunologic Deficiency Syndromes
Anatomical therapeutic chemical (ATC) code
J06BA01
Publication details
Marketing-authorisation holder
CSL Behring GmbH
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
14/04/2011
Contact address
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany

Product information

05/03/2018 Hizentra - EMEA/H/C/002127 - II/0087

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 in primary immunodeficiency syndromes such as:

  • congenital agammaglobulinaemia and hypogammaglobulinaemia;
  • common variable immunodeficiency;
  • severe combined immunodeficiency;
  • immunoglobulin-G-subclass deficiencies with recurrent infections;
  • replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Assessment history

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