Awareness of, and Compliance with, Domperidone Revised Labeling After a Risk-Minimization Activity in Europe
2019
Background and Objective
Risk-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, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures.
Keywords:
- Correction
- Source
- Cite
- Save
- Machine Reading By IdeaReader
12
References
2
Citations
NaN
KQI