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Each country or region has their own regulatory body. In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet".
The Electronic Medicines Compendium is a provider of information on medicines, produced by Datapharm. It lists summaries of product characteristics and patient information leaflets . [ 1 ] [ 2 ]
Prescription drugs are often dispensed together with a monograph (in Europe, a Patient Information Leaflet or PIL) that gives detailed information about the drug. The use of prescription drugs has been increasing since the 1960s.
Pages for logged out editors learn more. Contributions; Talk; Patient information leaflets
The details of label includes the name of preparation, quantity of drugs, instructions for patients, patient's name and the date of dispensing. Drug labelling, also referred to as prescription labelling, is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug ...
In the case of estradiol/levonorgestrel, detailed ePRO data on bleeding/spotting from a one-year clinical trial are presented in the patient information leaflet. [17] As well as clinical trial use, ePRO methods may be used to support patients in regular care. An example of this is the collection of symptom data from patients undergoing ...
A Medication Administration Record [1] (MAR, or eMAR for electronic versions), commonly referred to as a drug chart, is the report that serves as a legal record of the drugs administered to a patient at a facility by a health care professional. The MAR is a part of a patient's permanent record on their medical chart. The health care ...
Medication packaging includes a document that provides information about that drug and its use. In the US, this information is overseen by the Center for Drug Research and Evaluation (CDER), a branch of the Food and Drug Administration (FDA). For prescription medications, the insert is technical, and provides information for medical ...