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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE INSERT AND/OR TECHNICAL DATA SHEET OF GADOLINIUM-BASED CONTRAST MEDIA

La DIGEMID a través de la Resolución Directoral Nº 9046-2018-DIGEMID/DPF/MINSA publicada el 07 de diciembre de 2018 en su Portal Institucional, dispuso que los titulares de los Registros Sanitarios de los medios de constraste basados en gadolinio (ácido gadotérico, gadobutrol, ácido gadopentético, gadodiamida, gadoversetamida, ácido gadoxético, gadoteridol) deberán modificar la información de seguridad en los apartados de ADVERTENCIAS Y PRECAUCIONES, USO EN POBLACIONES ESPECIALES y REACCIONES ADVERSAS del 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.
Source: DIGEMID

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