Summary of Product Characteristics

Also called SmPC.

Term used in the European Union to refer to the drug label.  The SmPC describes the properties and the officially approved conditions of use of a medicine, and is intended for use by healthcare professionals.  The section on “Pharmacological Properties” often lists/describes trials that were involved in the evidence development program.  The SmPC is part of the European Public Assessment Report (EPAR).

Example: Olazax (Olanzapine) PDF pages 2-81 (source)

[fusion_imageframe image_id=”” style_type=”dropshadow” stylecolor=”” hover_type=”liftup” bordersize=”1″ bordercolor=”” borderradius=”” align=”none” lightbox=”no” gallery_id=”” lightbox_image=”” alt=”” link=”” linktarget=”_self” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=””]https://restoringtrials.org/wp-content/uploads/2018/01/product-char.png[/fusion_imageframe]