Articles with "revised labeling" as a keyword



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Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe

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Published in 2019 at "Clinical Drug Investigation"

DOI: 10.1007/s40261-019-00831-3

Abstract: Background and ObjectiveRisk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices,… read more here.

Keywords: revised labeling; domperidone; compliance; risk minimization ... See more keywords