Challenges and lessons learned from a long-term postauthorisation safety study programme of rivaroxaban in Europe

Challenges and lessons learned from a long-term postauthorisation safety study programme of rivaroxaban in Europe

Objectives To describe opportunities and challenges experienced from the four pharmacoepidemiological database studies included in the rivaroxaban post authorisation safety study (PASS) programme and propose ways to maximise the value of population-based observational research when addressing regula...

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Main Authors: Luis Alberto García Rodríguez, Montse Soriano-Gabarró, Pareen Vora, Yanina Balabanova, Gunnar Brobert, Kiliana Suzart-Woischnik, Ana Ruigomez, Leif Friberg, Ron Herings, Karin M A Swart, Tania Schink, Elisabeth Smits, Annemarie Voss, Christine Tarenz, Martin Homering, Tomasz Dyszynski, Gerd Nagel, Pablo Amaya
Format: Article
Language:English
Published: BMJ Publishing Group 2024-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/14/3/e081348.full
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