Summary of Product Characteristics (SmPC)

The SmPC is a full, official description of a pharmaceutical product, which lists the name of the active substance, its composition, uses, dosages, pharmaceutical forms, and known adverse reactions, amongst other information. The SmPC is the basis of information for health professionals on how to use the medicinal product safely and effectively. The condensed version provided to patients with the medicine in the form of a “patient information leaflet” (PIL) must be written in language that is easily understood by non-professionals.


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