Glossary

Package Insert

PI
Package Insert is the information leaflet designated to provide authorized professionals - physicians, dentists, pharmacists, with the key characteristics of the product with emphasis on the safety aspects of use - contraindications, drug interactions, dosage, adverse events, warnings and mechanisms of action.

The layout of the PI is uniform and as shown on the illustration below with red color coding designed to attract the attention to the most critical information. Shown below are:

• Translated in English a PI of marketed drug
• Diagram demonstrating the standard content (key entries and chapter titles) of PI. Actual PI of drugs marketed in Japan are 3-5 pages densely-printed documents.

 

Package Insert Mobic Reports: 6_D_K001

The full text in English of the Japanese Package Insert for Mobic (meloxicam) registered to and marketed in Japan by Nippon Boehringer Ingelheim KK. Formatted, indexed and hyperlinked. 34-page Drugs Lifecycle document.

Source: JPMA