Disclaimer

This example is for illustration purposes only. The data provided may not be up-to-date, and in some cases, 'dummy' data has been included. The product information included here shall not be used for any other purpose than for educational purposes regarding the IDMP-O implementation.

Introduction

Terlipressin is a synthetic analogue of vasopressin, a hormone which regulates blood pressure and water retention in the body. It is approved among others for the therapeutic indication bleeding oesophageal varices in Europe. However, national regulatory requirements, history heritage or differences in the way the Summary of Product Characteristics (SmPC) or Patient Information Leaflet (PIL) are edited lead to different expressions of strength across EU countries for the same product. There is therefore, a perceived difference between products, within these markets. In the case of cross-border medicinal product information, products are perceived as different, leading to unnecessary questions, errors or rejections of the prescription. The details of Terlipressin as produced by SUN Pharmaceuticals and marketed in the European countries of United Kingdom, Sweden, and Netherlands are used here to demonstrate how the reference strength* of a pharmaceutical product can be depicted differently in different regions, and how the ontology model is then expanded to accommodate this complexity (further information can be obtained at https://github.com/edmcouncil/idmp/tree/master/EXT/Examples). The tables and figures below summarize the information obtained from the different SmPCs, PILs and Dossiers of Terlipressin as marketed by SUN Pharmaceuticals. In all instances, the same product is manufactured and sold. However they are presented differently in different countries.

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