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Information Letter on Zeposia (Ozanimod): Modified dosing recommendation for mild or moderate chronic hepatic impairment (Child-Pugh class A or B)

2023.08.18

Active substance: ozanimod

Bristol Myers Squibb, in coordination with the German Federal Institute for Drugs and Medical Devices (BfArM), informs about the recommendation for dose reduction in patients with mild or moderate chronic hepatic impairment (Child-Pugh class A or B) due to the risk of overdose. The training material (checklist for physicians) has been updated accordingly and has been sent to healthcare professionals together with this information letter.

Available in German only:

Checkliste zur Verringerung von Arzneimittel- und Anwendungsrisiken für Ärztinnen und Ärzte PDF, 2MB, File does not meet accessibility standards

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 134KB, File is accessible