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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF THE PHARMACEUTICAL SPECIALTIES CONTAINING "CANAGLIFLOZIN, DAPAGLIFLOZIN AND EMPAGLIFLOZIN (SGLT-2 INHIBITORS)"

La DIGEMID a través de la Resolución Directoral Nº 9380-2018-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 “CANAGLIFLOZINA, DAPAGLIFLOZINA Y EMPAGLIFLOZINA (INHIBIDORES DE SGLT-2)”, deberán modificar la información de seguridad, tanto en inserto y/o ficha técnica de estos productos.
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Source: DIGEMID
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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