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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT, TECHNICAL DATA SHEET AND/OR MEDIATE LABELING OF MEDICINES CONTAINING "VALPROATE"

La DIGEMID a través de la Resolución Directoral Nº 5972-2018-DIGEMID/DPF/MINSA publicada el 07 de agosto de 2018 en su Portal Institucional dispuso que los titulares de los Registros Sanitarios de las especialidades farmacéuticas que contengan “VALPROATO (Ácido  valproico, valproato de sodio y valproato semisódico)” deben incluir modificaciones de seguridad en el inserto, ficha técnica y/o rotulado mediato de estos productos; y deberán presentar un Plan de Gestión de Riesgos a la Dirección de Farmacovigilancia, Acceso y Uso de acuerdo a las recomendaciones de guías internacionales.
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El plazo máximo para la realización de estas modificaciones y para la presentación del Plan de Gestión de Riesgos en mención es de sesenta (60) días hábiles a partir del día siguiente de la publicación de la mencionada Resolución Directoral.
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Source: DIGEMID

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