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)
