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human normal immunoglobulin (Panzyga®)


Reference No. 3303

Publication date:
30/09/2016


Appraisal information

human normal immunoglobulin (Panzyga®) 100 mg/ml solution for infusion


Company: Octapharma AG
BNF category: Unspecified
NMG meeting date: Not scheduled
AWMSG meeting date: Not scheduled
   
   
Submission Type: Nonsubmission
Status: Not endorsed
Advice No: Not available
Ratification by Welsh Government: 29/09/2016

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ratification by
Welsh Government

AWMSG 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.
Statement of Advice (SOA)
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