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human normal immunoglobulin (Cuvitru®)

Reference No. 3338

Publication date:

Appraisal information

human normal immunoglobulin (Cuvitru®) solution for injection

Company: Shire Pharmaceuticals Ltd
BNF category: Immunological products and vaccines
NMG meeting date: Not scheduled
AWMSG meeting date: Not scheduled
Submission Type: Nonsubmission
Status: Not endorsed
Advice No: Not available
Ratification by Welsh Government: 25/05/2017

Current Progress

Ratification by
Welsh Government

AWMSG 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)