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Remifentanil is FDA-approved in the United States as analgesic agent during induction and maintenance of general anesthesia, immediate postoperative analgesia under anesthesia supervision, analgesic component of monitored anesthesia care in adults.
In Europe, it is authorized mainly as nationally authorized products like UltivaTM, not as a centralized EMA EPAR product. The EMA document lists remifentanil as a nationally authorized medicinal product across multiple European countries.
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