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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES THAT CONTAIN "TRAMADOL"

La DIGEMID a través de la Resolución Directoral Nº 9379-2018-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 “TRAMADOL”, deberán modificar la información de seguridad, tanto en el inserto y/o ficha técnica de estos productos.
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The maximum period for carrying out these modifications is thirty (30) business days from the day after the publication of the aforementioned Directorial Resolution on the DIGEMID Institutional Portal.
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Source: DIGEMID

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