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human normal immunoglobulin (Cuvitru®)

 

Following non-submission

AWMSG advice

Status: Not endorsed (Statement of Advice)

In the absence of a submission from the holder of the marketing authorisation, human normal immunoglobulin (Cuvitru®) cannot be endorsed for use within NHS Wales for use as a replacement therapy in adults, and 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 bacterial infections in multiple myeloma (MM) patients; Hypogammaglobulinaemia in patients pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT).

 Statement of Advice (SOA): human normal immunoglobulin (Cuvitru) 3338 (PDF, 97Kb)

Medicine details

Medicine name human normal immunoglobulin (Cuvitru®)
Formulation Solution for injection
Reference number 3338
Indication

Replacement therapy in adults, and 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 bacterial infections in multiple myeloma (MM) patients; Hypogammaglobulinaemia in patients pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT)

Company Shire Pharmaceuticals Ltd
BNF chapter Immunological products & vaccines
Submission type Non-submission
Status Not endorsed (Statement of Advice)
Date of issue 25/05/2017
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