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they do not independently establish the safety, effectiveness, quality, dose equivalence, or expected results of the compounded preparation dispensed through Zevay's program

Se produce despus de una revisin exhaustiva realizada por el Comit para la Evaluacin de Riesgos en Farmacovigilancia de la Agencia Europea del Medicamento, que analiz datos de ensayos clnicos, estudios preclnicos, notificaciones de reacciones adversas y literatura cientfica

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Its also a strategic legal move