Following non-submission
AWMSG advice |
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| 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). |
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Medicine details |
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| 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) |
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| Company | Shire Pharmaceuticals Ltd | |
| BNF chapter | Immunological products & vaccines | |
| Assessment type | Non-submission | |
| Status | Not endorsed (Statement of Advice) | |
| Date of issue | 25/05/2017 | |