Directive 2001/83/EC. Community code relating to medicinal products for human use, March 2010. http://europa.eu/legislation_summaries/internal_market/ single_market_for_goods/pharmaceutical_and_cosmetic_products/l21230_en.htm (accessed 6 sep 2012)
uropean Medicines Agency. Guideline on the investigation of bioequivalence, March 2010. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf (accessed 6 sep 2012)
Caress JB, Kennedy BL, Eickman KD. Safety of intravenous immunoglobulin treatment. Expert Opin Drug Saf 2010;9:971-9.
European Medicines Agency. Guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg), (March 2010). http:// www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/ WC500078472.pdf (accessed 6 sep 2012)
Gürcan HM, Keskin DB, Ahmed AR. Information for healthcare providers on general features of IGIV with emphasis on differences between commercially available products. Autoimmun Rev 2010;9:553-9.
ropean Medicines Agency. Questions and answers on the recommendation to lift the suspension of Octagam (human normal immunoglobulin 5% and 10%), March 2010. http://www.ema.europa.eu/docs/en_GB/document_library/ Referrals_document/Octagam_31/WC500105245.pdf (accessed 6 sep 2012)
oemisch JR, Kaar W, Zoechling A, et al. Identification of activated FXI as the major biochemical root cause in IVIG batches associated with thromboembolic events. Analytical and experimental approaches resulting in corrective and preventive measures implemented into the Octagam manufacturing process. Webmed Cent Immunother 2011;2:WMC002002.
tscheid M, Breitner-Ruddock S, Gross S, et al. Identification of kallikrein and FXIa as impurities in therapeutic immunoglobulins: implications for the safety and control of intravenous blood products. Vox Sang 2012;102:40-6.
Alving BM, Tankersley DL, Mason BL, et al. Contact-activated factors: contaminants of immunoglobulins preparations with coagulant and vasoactive properties. J Lab Clin Med 1980;96:334-46.
Wolberg AS, Kon RH, Monroe DM, et al. Coagulation factor XI is a contaminant in intravenous immunoglobulin preparations. Am J Hematol 2000;65:30-4.