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All suspected adverse reactions to Mounjaro should be reported, especially: Serious reactions, regardless of whether they are well-recognised Reactions resulting in hospitalisation or prolonged hospitalisation Suspected reactions causing congenital abnormalities Any reaction not previously documented in the Summary of Product Characteristics Reports can be submitted online at www.mhra.gov.uk/yellowcard , via the Yellow Card app, or by telephone

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According to the applicant, the aprevo Cervical ACDF System device is different from C1831 because (1) the original (lumbar-specific) aprevo and the nominated aprevo Cervical ACDF System are separate and distinct products that have no overlap in anatomical indications for use or patient population