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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF MEDICINES CONTAINING "LINAGLIPTIN AND SITAGLIPTIN"

La DIGEMID a través de la Resolución Directoral Nº 3603-2018-DIGEMID/DPF/MINSA publicada el 21 de mayo de 2018 en su Portal Institucional dispuso que los titulares de los Registros Sanitarios de las especialidades farmacéuticas que contengan “Linagliptina y Sitagliptina” deben incluir modificaciones de seguridad en el inserto y/o ficha técnica de estos productos.
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La inclusión de estas modificaciones se da en el marco del Informe de Seguridad remitido por la Dirección de Farmacovigilancia, Acceso y Uso de la mencionada institución.
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El plazo máximo para la realización de estas modificaciones es de treinta (30) 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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