Hizentra

RSS

human normal immunoglobulin (SCIg)

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

Overview

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);
  • secondary immunodeficiencies (SID) in people who have severe or recurrent infections that do not respond to treatments and who are unable to produce certain antibodies;
  • chronic inflammatory demyelinating polyneuropathy (CIDP). In this condition, 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 13/01/2022

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
21
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

15/11/2021 Hizentra - EMEA/H/C/002127 - II/0129

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 (see section 4.4).


- Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.

*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines.

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


- Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.

 

Assessment history

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