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Annotated abstract

Antibiotic labels frozen in time: a barrier to effective antimicrobial stewardship?

ejhpharm · 2025-09-25 · canonical JSON source

4 visible annotations · policy: published · automated confidence ≥ 75.00%

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Antimicrobial stewardship (AMS) has advanced considerably across Europe, yet an often overlooked barrier persists: the misalignment between clinical practice and the Summary of Product Characteristics (SmPC) for many legacy antibiotics. Most off-patent agents still carry SmPCs based on decades-old data, overlooking the vast body of evidence generated since their original approval. This situation generates a paradox: healthcare professionals are encouraged to follow international guidelines and AMS principles, but regulatory information lags far behind.