BAYN.DE CHMP opinion: Thursday, July 23, 2026

EventCHMP opinion
DateThursday, July 23, 2026
MarketEU listing
SourceEMA CHMP · confidence 90% · primary source ↗

Variation type II · Xofigo · Submission of final study report from study 20511 listed in Annex IID of the SmPC. This is a phase I biodistribution study to further characterise correlation between the extent of the disease, the dose and the distribution of radium-223 in bone metastases versus sites o

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