Abstract
Prescribing medicinal product labels or “summary of product characteristics” (SmPC) comprise essential scientific information that allows healthcare professionals the safe and effective prescription of marketed products [1,2]. The included information is agreed between the regulatory agency and the marketing authorization holder, who should review SmPCs at least once a year to ensure that the information remains accurate and up-to-date [2]. When a medicinal product is first authorized, its SmPC summarizes the safety and efficacy data gathered in preregistration clinical trials.
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