ROYSTON, D.; DE HERT, S.; VAN DER LINDEN, J.; OUATTARA, A.; ZACHAROWSKI, K.

doi:10.1016/j.accpm.2017.02.001

Métadonnées

Afficher la notice complète

Licence d’utilisation du document

Langue

Article de revue

Ce document a été publié dans

Anaesth Crit Care Pain Med. 2017 n° 36, p. 2

Résumé en anglais

Aprotinin injection (Trasylol®) has been relicensed for use during cardiac surgery throughout Canada and Europe. Nordic Group B.V. acquired the rights for aprotinin injection from Bayer Shering Pharma and will be wholly responsible for distributing aprotinin injection throughout Europe. This process has started in some countries and will continue throughout Europe over the next 2–3 years. Nordic had been supplying aprotinin on a ‘named patient basis’ in some countries such as the UK. This use was classified as unlicensed or off-label use and this will be changed to the licensed compound in due course. The purpose of this contribution is to address four issues related to the relicense process: • first to suggest why aprotinin therapy is still required in modern cardiac surgical practice; • second to explain why regulators have allowed aprotinin to be relicensed based on its benefit/risk profile; • third, to explain the conditions regulators have imposed to allow this relicense process and in particular establishing the Nordic Aprotinin Patient Registry (NAPaR); • finally to point out some of the basics of the use of Aprotinin injection and to explain some of the potential difficulties associated with its clinical use that regulators wanted to highlight.< Réduire

Mots clés

*Article CLINIQUE

Mots clés en anglais

Aprotinin

Benefit-Risk analysis

Conditions of use

Nordic Aprotinin Patient Registry (NAPaR)

Relicense