Prescribing information (revision 5)
Old revision·14:13, 24 Oct 2024·SarcopeniaSefa
| Prescribing information | |
|---|---|
| Also called | Label; summary of product characteristics |
| Approved by | The medicines regulator |
| Jurisdictional | Differs between countries for the same product |
| Topic infobox · conventions | |
Prescribing information is the regulator-approved labelling accompanying a medicine, stating its indications, dosing, contraindications, warnings, adverse effects, pharmacology and the studies supporting them. In Europe the equivalent document is the summary of product characteristics.[1]
It is a regulated document rather than a manufacturer's description. Its content is negotiated with the regulator and changes require approval, which is why it is a more reliable source than promotional material and why it lags the literature.[1]
It is jurisdiction-specific. The same product may carry different indications, different populations and different warnings in different countries, so the label of one jurisdiction does not describe the product in another.[2]
Structure
[edit]Labelling follows a prescribed structure so that the same information is in the same place across products: indications, dosage and administration, dosage forms, contraindications, warnings and precautions, adverse reactions, drug interactions, use in specific populations, description, clinical pharmacology, non-clinical toxicology, clinical studies, and storage.[1]
The clinical studies section reports the trials supporting the indication, with the effect sizes as the regulator accepted them. It is a useful primary-adjacent source: the numbers are those the regulator reviewed rather than those a press release selected.[2]
Warnings and precautions differ from contraindications: a contraindication says the product is not to be used, a warning that a risk exists and is to be managed. Conflating them overstates the restriction. See Contraindications of incretin therapy.[1]