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DIGEMID ORDERED SAFETY MODIFICATIONS IN THE TECHNICAL DATA SHEET AND/OR INSERT OF PHARMACEUTICAL SPECIALTIES CONTAINING "HORMONAL CONTRACEPTIVES"

La DIGEMID a través de la Resolución Directoral Nº 5618-2019-DIGEMID/DPF/MINSA publicada el 16 de julio de 2019 en su portal institucional, dispuso que los titulares de los registros sanitarios de las especialidades farmacéuticas que contengan “ANTICONCEPTIVOS HORMONALES” y que presentan la indicación de uso anticonceptivo, deberán modificar la información de seguridad en la ficha técnica y el inserto de estos productos.

El plazo máximo para la realización de estas modificaciones es de treinta (30) días hábiles a partir del día siguiente de la publicación de la mencionada Resolución Directoral en el portal institucional de la DIGEMID.

Source: DIGEMID

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