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Direct Healthcare Professional Communication (DHPC) on Oxbryta (voxelotor): Suspension of EU marketing authorisation

Active substance: voxelotor

Pfizer Europe in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) would like to inform you that the marketing authorisation for Oxbryta is suspended in the European Union as a precautionary measure while the review of the benefits and risks is ongoing. All batches of Oxbryta are being recalled in the European Union and the use of Oxbryta in clinical trials and in early access programs is also being discontinued.

Download DHPC/Information letter , Download_VeroeffentlichtAm_EN PDF, 454KB, File is accessible