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Evaluation of the Effectiveness of the Risk Minimization Measures of Sodium Oxybate in the European Union
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 misuse....
Autores principales: | Iranzo, Alex, Serralheiro, Pedro, Schuller, Jan-Christof, Schlit, Anne-Françoise, Bentz, Jürgen W. G. |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7581670/ https://www.ncbi.nlm.nih.gov/pubmed/32989679 http://dx.doi.org/10.1007/s40801-020-00212-9 |
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