Summary of Product Characteristics [SmPC]

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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).

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