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DIGEMID ORDERED SECURITY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET AND MEDIATE AND IMMEDIATE LABELING OF PHARMACEUTICAL SPECIALTIES CONTAINING "HYDROXYETHYL STARCH"

La DIGEMID a través de la Resolución Directoral Nº 9126-2018-DIGEMID/DPF/MINSA que fue publicada el 20 de diciembre de 2018 en su Portal Institucional, dispuso que los titulares de los Registros Sanitarios de las Especialidades Farmacéuticas que contengan “HIDROXIETIL ALMIDON”, deberán modificar la información de seguridad, tanto en el inserto y/o ficha técnica y rotulado mediato e inmediato de estos productos.
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El plazo máximo para la realización de estas modificaciones es de sesenta (60) días hábiles a partir del día siguiente de la publicación de la mencionada Resolución Directoral    en el Portal Institucional de la DIGEMID.
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Source: DIGEMID

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