Glossary

Explanation of terms used by DrugBank

Drug label

Synonyms:
Label, Monograph, Product label, Product monograph

In DrugBank, a drug label refers to a scientific document describing a drug product that provides information about the properties, indications, and conditions of use of the drug and contains other information that may be required for safe and effective use.

The drug label may be a U.S. Food and Drug Administration (FDA) label, Health Canada product monograph, European Medicines Agency (EMA) label, a European Public Assessment Report (EPAR), an Australian Public Assessment Report (AUSPAR), or a Medsafe New Zealand Medicines (MedSafe NZ) report. In Drugbank, the above mentioned labels are considered drug labels, as well as product monographs created by pharmaceutical companies. For example, the product monograph for Pr TECTA 2, written by Takeda Pharmaceuticals Canada, may be included as a drug label in DrugBank. NIH DailyMed entries are also considered drug labels 1

Often, drug labels are directly accessible in DrugBank entries by clicking on the "Label" hyperlink 3 or are attached as PDF files in the "General references" 4 section of the drug entry.

References:

  1. DailyMed: Pantoprazole sodium [Link]
  2. Pr TECTA® Monograph, Takeda [File]
  3. Pantoprazole Drug Entry, "Label" hyperlink [File]
  4. Pantoprazole Drug Entry, References Section including Drug Labels [File]