European Commission Withdraws EU Marketing Authorisation For Zinplava At Merck Sharp & Dohme B.V.’s Request After Permanent Discontinuation For Commercial Reasons

On 20 October 2026, the European Commission withdrew the marketing authorisation for Zinplava (bezlotoxumab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Zinplava was granted marketing authorisation in the EU on 18 January 2017 for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk of CDI recurrence. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2021. An extension of indication to children from 1 year of age was granted in December 2023.