Prescribing information (revision 2)
Old revision·23:20, 9 Sep 2024·SPPS_Sorrel
| 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]
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]