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Adcetris, Zelboraf, Stelara on new EMA list of safety actions

This article was originally published in Scrip

Executive Summary

The European Medicines Agency has published the first monthly overview of recommendations by its pharmacovigilance risk assessment committee (PRAC) regarding actual or potential safety issues with products marketed in the EU. Among the products requiring a safety update is Takeda's Adcetris (brentuximab vedotin), while additional information has been requested for a number of drugs including Roche's Zelboraf (vemurafenib), Janssen's Stelara (ustekinumab) and Amgen's Prolia/Xgeva (denosumab).

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