Summary of Product Characteristics (SmPC)
The EU equivalent of the US prescribing information — a legally binding document approved as part of the marketing authorisation that provides healthcare professionals with all information needed to prescribe and monitor a medicine safely and effectively.
Technical Context
SmPC structure (EU directive 2001/83/EC, Annex I, Part 1): Section 1 (Name), 2 (Qualitative/Quantitative Composition), 3 (Pharmaceutical Form), 4.1 (Therapeutic Indications), 4.2 (Posology/Method of Administration), 4.3 (Contraindications), 4.4 (Special Warnings/Precautions), 4.5 (Interactions), 4.6 (Fertility/Pregnancy/Lactation), 4.7 (Effects on Driving), 4.8 (Undesirable Effects), 4.9 (Overdose), 5.1 (Pharmacodynamic Properties), 5.2 (Pharmacokinetic Properties), 5.3 (Preclinical Safety Data), 6 (Pharmaceutical Particulars — excipient list, incompatibilities, shelf life, storage, container). The SmPC is the basis for all EU product information — the Patient Information Leaflet (PIL) must be consistent with the SmPC. SmPCs are publicly available on the EMA website for centrally authorised products and on national agency websites for nationally authorised products.