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Home » EMA Guidances Address Hep B, Human Normal Immunoglobulins
EMA Guidances Address Hep B, Human Normal Immunoglobulins
January 2, 2013
The efficacy of immunoglobulins to prevent hepatitis B must be based on demonstrating compliance with European Pharmacopeia quality standards and pharmacokinetic and safety data consistent with published literature in 20 patients negative for hepatitis B, a European Medicines Agency draft guideline says.