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In its complete response letter, the regulator requested that AstraZeneca improve Ultomiris Risk Evaluation and Mitigation Strategy (REMS) strategy to further validate patients meningococcal vaccination status or prophylactic administration of antibiotics prior to treatment with the C5 complement inhibitor

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The liver metabolizes both alcohol and acetaminophen, and when these substances are combined, toxic byproducts can be produced, which can harm the liver