Hizentra

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Questions & Answers

On 25 January 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Hizentra. The marketing authorisation holder for this medicinal product is CSL Behring GmbH.

The CHMP adopted a new indication as follows:

“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.”

For information, the full indications for Hizentra will be as follows1:

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

  • Primary immunodeficiency syndromes with impaired antibody production (see section 4.4).
  • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated.
  • Hypogammaglobulinaemia and recurrent infections in multiple myeloma (MM) patients.
  • Hypogammaglobulinaemia in patients, pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).

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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 New text in bold

Name Language First published Last updated
CHMP post-authorisation summary of positive opinion for Hizentra (II-0087) (English only) 2018-01-26  

Key facts

Product details for Hizentra
NameHizentra
INN or common name

human normal immunoglobulin (SCIg)

Therapeutic area Immunologic Deficiency Syndromes
Active substance

human normal immunoglobulin (SCIg)

Date opinion adopted25/01/2018
Company name

CSL Behring GmbH

StatusPositive
Application typePost authorisation