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 (Aragam®) cannot be endorsed for use within NHS Wales for replacement therapy in primary immunodeficiency syndromes such as: congenital agammaglobulinemia and hypogammaglobulinemia; common variable immunodeficiency; severe combined immunodeficiency and Wiskott Aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia and recurrent infections; children with congenital AIDS and recurrent infections; immunomodulation; idiopathic thrombocytopenic purpura; children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease; allogeneic bone marrow transplantation. |
||
|
||
Medicine details |
||
Medicine name | human normal immunoglobulin (Aragam®) | |
Formulation | 50 mg/ml solution for infusion | |
Reference number | 1548 | |
Indication | Replacement therapy in primary immunodeficiency syndromes such as: congenital agammaglobulinemia and hypogammaglobulinemia; common variable immunodeficiency; severe combined immunodeficiency and Wiskott Aldrich syndrome; myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinemia and recurrent infections; children with congenital AIDS and recurrent infections; immunomodulation; idiopathic thrombocytopenic purpura; children or adults at high risk of bleeding or prior to surgery to correct the platelet count; Guillain Barré syndrome; Kawasaki disease; allogeneic bone marrow transplantation |
|
Company | Oxbridge Pharma Ltd | |
BNF chapter | Immunological products & vaccines | |
Submission type | Non-submission | |
Status | Not endorsed (Statement of Advice) | |
Date of issue | 08/03/2012 |