Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union

Abstract Background Sodium oxybate (Xyrem®), approved by the European Medicines Agency (EMA) for narcolepsy with cataplexy, is only available through risk mitigation programs due to potential adverse effects including respiratory and central nervous system depression, neuropsychiatric events, and mi...

Full description

Bibliographic Details
Main Authors: Alex Iranzo, Pedro Serralheiro, Jan-Christof Schuller, Anne-Françoise Schlit, Jürgen W. G. Bentz
Format: Article
Language:English
Published: Adis, Springer Healthcare 2020-09-01
Series:Drugs - Real World Outcomes
Online Access:https://doi.org/10.1007/s40801-020-00212-9