(Also known as prescribing information, product information, labelling, package insert, summary of product characteristics) The content of this document varies by regulator, but generally is an official description of a medical product that includes the indication (for what the medicine is used, and in which population), contraindications, adverse events, instructions for safe use, and technical details. Labels may also include information on clinical pharmacology, toxicology, and clinical trials. This information generally has a primary audience of healthcare professionals, and in the United States can be searched for on DailyMed (NIH), the FDA Online Label Repository, and Drugs@FDA. In the EU, drug labels are referred to as the Summary of Product Characteristics, and can be searched for on EMA’s website (at present, they can be found under the “Product information” tab of the drug’s page on EMA’s website). Information specifically written for patients is found in Medication Guides, Patient Package Inserts, and Patient Information Leaflets, often found attached to the healthcare professional information.
Example: Dalvance (dalbavancin) FDA approved label below (source)
Also see: Xydalba (dalbavancin) EMA Summary of Product Characteristics
