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Hizentra (human normal immunoglobulin (SCIg)) – new indication Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) (inflammatory disease of the nerves)

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 follows:

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

  • Primary immunodeficiency syndromes with impaired antibody production.
  • 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.”

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