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For prescription medications, the insert is technical, providing information for medical professionals about how to prescribe the drug. Package inserts for prescription drugs often include a separate document called a "patient package insert" with information written in plain language intended for the end-user —the person who will take the ...
This infobox provides information over-the-counter and prescription-only drugs. It can be used for single drugs, combination products, monoclonal antibodies and vaccines.
* Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products).
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
The template does not at the current time include summary information about the drug class itself. Instead, it contains a consistent interface to other sources that provide information about the drug class. Don't worry about trying to fill in all the fields – even if you can only get one or two, that still can be useful.
There are three major licensing authorities that make drug information online accessible: the European Medicines Agency (EMA, EU), and the Food and Drug Administration (FDA, US). The FDA "Label Information" and the EMA "Product Information", where available, are very detailed.
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