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DIGEMID DISPUSO MODIFICACIONES DE SEGURIDAD EN EL INSERTO Y FICHA TÉCNICA DE ESPECIALIDADES FARMACÉUTICAS QUE CONTENGAN “DENOSUMAB”

La DIGEMID a través de la Resolución Directoral Nº12213-2017 DIGEMID/PDF/MINSA publicada el 14 de diciembre de 2017 en su Portal Institucional dispuso que los titulares de registro sanitario de productos farmacéuticos que contengan DENOSUMAB deben incluir modificaciones de seguridad en su inserto y/o en su ficha técnica.
La inclusión de estas modificaciones se da en el marco del Informe de Seguridad remitido por la Dirección de Farmacovigilancia, Acceso y Uso.
Además se dispone que el plazo para la realización de estas modificaciones sea de no mayor de treinta (30) días hábiles a partir del día siguiente de la publicación de la mencionada Resolución Directoral.
Source: DIGEMID

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