Skip to main content

human normal immunoglobulin (Aragam®)

 

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.

 Statement of Advice (SOA): human normal immunoglobulin (Aragam) 1548 (PDF, 44Kb)

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
Follow AWTTC: