On November 7, 2023, the Public Health Institute of Chile (ISP) issued the exempt resolution No. 5855 instructing the update of information leaflets for healthcare professionals and patients regarding pharmaceutical products containing DENOSUMAB as the active ingredient in their composition.
In the update required by the ISP, the incorporation of safety information regarding the possibility of adverse reactions associated with musculoskeletal and connective tissue disorders, such as jaw osteonecrosis, external auditory canal osteonecrosis, and multiple vertebral fractures following treatment discontinuation, is established.
The deadline for incorporating this information into the “Warnings and Precautions” section of the information leaflets is no more than 90 business days from the date of publication of the resolution.
You can find the complete document of Resolution No. 5855 at the following link.
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