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Calling for regulatory action Spontaneous reports of DIP can prompt regulatory authorities such as the European Medicines Agency (EMA) or national competent authorities to evaluate the need for label updates, including additions to the Summary of Product Characteristics (SmPC) or Package Leaflets (PLs)

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Whilst gastrointestinal side effects (particularly with high-fat meals) are common, orlistat has a well-established safety profile and can produce modest weight loss (typically 2-3 kg more than diet and exercise alone over one year)

Common injection sites include the abdomen, thighs, arms, and chin