Intravenous Iron preparation: CMDh Scientific Conclusions and Reasons for Deviations, Amendments to Product Information and Implementation Schedule – EMEA / H / N / PSR / J / 0026

Based on PRAC’s review of the final PASS Study Report Version 1.1, PRAC believes that the condition of the PASS to further characterize the safety concerns about hypersensitivity reactions with respect to the safe and effective use of intravenous iron-containing medications can be removed.