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). |
||
|
||
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 |