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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "ULIPRISTAL ACETATE 5mg"

La DIGEMID a través de la Resolución Directoral Nº 847-2018-DIGEMID/DPF/MINSA publicada el 31 de octubre de 2018 en su Portal Institucional, dispuso que los titulares de los Registros Sanitarios de las especialidades farmacéuticas que contengan “ACETATO DE ULIPRISTAL 5mg”, deberán modificar la información de seguridad en los apartados de INDICACIONES, CONTRAINDICACIONES, ADVERTENCIAS Y PRECAUCIONES y REACCIONES ADVERSAS del inserto y/o ficha técnica de estos productos.
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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