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Xofigo®: EMA restricts use of prostate cancer medicine Xofigo
2017.12.04
Active substance: Radium-223 dichloride
30.07.2018 - CHMP opinion
Medicine should only be used after two previous treatments or when other treatments cannot be taken.
16.07.2018 - PRAC recommendation
Restricting use of the medicine Xofigo® to patients who have had two previous treatments or who cannot receive other treatments.
04.12.2017 - Procedure started
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has started an investigation on the increased risk of death and bone fractures reported in an ongoing clinical trial with the prostate cancer medicine Xofigo® (radium-223 dichloride).
Further information
For details on the procedure please click on the following link to the homepage of the European Medicines Agency (EMA):