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. 2021 Jan 22;100(3):e23935. doi: 10.1097/MD.0000000000023935

Table 6.

Recommended guidelines on immunoglobulin use.

Number Country Issue time Organization Guidelines
1 USA 2008 U.S. Department of Health and Human Services; Food and Drug Administration; Center for Biologics Evaluation and Research Guidance for IndustrySafety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency http://www.fda.gov/cber/gdlns/igivimmuno.htm.
2 UK 2019 Department of Health Updated Commissioning Criteria for the use of therapeutic immunoglobulin (Ig) in immunology, haematology, neurology, and infectious diseases in England, November 2019 chrome-extension://cdonnmffkdaoajfknoeeecmchibpmkmg/static/pdf/web/viewer. html?file= http%3A%2F%2Figd.mdsas.com%2Fwp-content%2Fuploads%2FNHSE_Commissioning_Criteria_for_the_use_of_Ig_V1.4_November_2019.pdf
3 Australia 2012 National blood authority Criteria for the clinical use of intravenous immunoglobulin in Australia https://www.blood.gov.au/system/files/documents/NBA_IVIgCriteria_Second
4 European 2018 European Medicines Agency Guideline on core SmPC for normal human immunoglobulin for intravenous administration (IVIg) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2018/07/WC500252345.pdf
5 China 2016 Comment on the lack of guidelines in China and comparative study of clinical guidelines for intravenous immunoglobulin in western countries http://d.wanfangdata.com.cn/periodical/zgxyylczz201601013 (comparative study of clinical guidelines for intravenous immunoglobulin)