United States Prescribing Information (USPI)
It sets out the agreed usage of the drug in the USA. It provides information for healthcare professionals on the drug’s usage, efficiency and safety. This is part if the drug’s marketing authorization in the USA. The equivalent in the EU is called the SmPC. Urgent union procedure In case of a serious concern concerning a medicinal product:
• The European Commission or a Member State trigger this alert procedure
• The EMA announces the procedure and gives supporting information
• The European Commission can ask Member States to take temporary urgent measures.