REGULATORY

G-CSF Preparations Ordered to Add Anaphylaxis in ADR List

September 14, 2016

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The Ministry of Health, Labor and Welfare (MHLW) on September 13 ordered the makers of G-CSF preparations, including Gran (filgrastim) and its biosimilar versions, to revise their labels to add anaphylaxis as a clinically significant adverse drug reaction (ADR). G-CSF…

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