The Case Against the European Medicines Agency's Change to the Label for Radium-223 for the Treatment of Metastatic Castration-resistant Prostate Cancer.

O'Sullivan, Joe M;Heinrich, Daniel;James, Nicholas D;Nilsson, Sten;Tombal, Bertrand;et.al.
(2019) European Urology — Vol. 75, n° 3, p. e51-e52 (2019)

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  • O'Sullivan, Joe M
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  • Heinrich, Daniel
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  • James, Nicholas D
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  • Nilsson, Sten
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Abstract
(en) We write regarding a recent label change recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) and implemented by the European Medicines Agency (EMA) for the bone-targeted agent radium-223 (Xofigo) [...]
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O’Sullivan, J. M., Heinrich, D., James, N. D., Nilsson, S., Ost, P., Parker, C. C., & Tombal, B. (2019). The Case Against the European Medicines Agency’s Change to the Label for Radium-223 for the Treatment of Metastatic Castration-resistant Prostate Cancer. European Urology, 75(3), e51-e52. https://doi.org/10.1016/j.eururo.2018.11.003 (Original work published 2019)