Aprotinin Relicense and Use of Nonapproved Interventions
- PMID: 31699596
- DOI: 10.1053/j.jvca.2019.10.001
Aprotinin Relicense and Use of Nonapproved Interventions
Conflict of interest statement
Conflict of interest As a condition of re-establishing the market licence the new Marketing Authorisation Holder, Nordic Pharma were required to establish a Risk Management Plan that involved a Post-Authorisation Safety Study known as NAPaR (Nordic Aprotinin Patient Registry). The authors of this letter are all members of the independent drug safety monitoring committee for NAPaR with SDH as chair.
Comment on
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A Systematic Review and International Web-Based Survey of Randomized Controlled Trials in the Perioperative and Critical Care Setting: Interventions Increasing Mortality.J Cardiothorac Vasc Anesth. 2019 Oct;33(10):2685-2694. doi: 10.1053/j.jvca.2019.03.022. Epub 2019 Mar 23. J Cardiothorac Vasc Anesth. 2019. PMID: 31064730
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