This chapter on the EU regulatory perspective of the intravenous immunoglobulins (IVIGs) encompasses the following topics: – Regulatory framework for IVIGs; – Current EMEA initiatives: revision of the core SPC/IVIG Guideline; – Paediatric Regulation: impacts/outcomes; – Patient involvement and consultation in the EMEA activities.
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Jacqueline Kerr (2008) studied this question.
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