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 (Panzyga®) cannot be endorsed for use within NHS Wales as replacement therapy in adults, and children and adolescents in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation; congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents in: primary immune thrombocytopenia, in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease. |
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Medicine details |
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Medicine name | human normal immunoglobulin (Panzyga®) | |
Formulation | 100 mg/ml solution for infusion | |
Reference number | 3303 | |
Indication | Replacement therapy in adults, and children and adolescents in: primary immunodeficiency syndromes with impaired antibody production; hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia, in whom prophylactic antibiotics have failed; hypogammaglobulinaemia and recurrent bacterial infections in plateau phase multiple myeloma patients who have failed to respond to pneumococcal immunisation; hypogammaglobulinaemia in patients after allogeneic haematopoietic stem cell transplantation; congenital AIDS with recurrent bacterial infections. Immunomodulation in adults, and children and adolescents in: primary immune thrombocytopenia, in patients at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease |
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Company | Octapharma AG | |
BNF chapter | Immunological products & vaccines | |
Submission type | Non-submission | |
Status | Not endorsed (Statement of Advice) | |
Date of issue | 29/09/2016 |