Summary of Product Characteristics

What is Summary of Product Characteristics?

Summary of Product Characteristics definition and meaning on Health terms:
The Summary of Product Characteristics (SmPC) is a document approved as part of the marketing authorisation of each medicine. It is aimed at healthcare professionals and includes information such as: How to use the medicine; What the medicine should be used to treat (therapeutic indications); Dose; Method of administration; In what conditions the medicine should not be used (contraindications); Special warnings; The medicine’s mechanism of action; and Any undesirable effects. The SmPC contains more detail than the Package Leaflet (PL).

 

reference: https://www.eupati.eu/glossary/

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