Zinplava

Withdrawn

This medicine's authorisation has been withdrawn

bezlotoxumab

Overview

Introduction

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. 

Zinplava : EPAR - Medicine overview

Reference Number: EMA/86503/2024

Zinplava : EPAR - Risk management plan

Product information

Zinplava : EPAR - Product Information

Zinplava : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Zinplava
• Active substance:
  Bezlotoxumab
• International non-proprietary name (INN) or common name:
  bezlotoxumab
• Therapeutic area (MeSH):
  Enterocolitis, Pseudomembranous
• Anatomical therapeutic chemical (ATC) code:
  J06BB21

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI.

Authorisation details

• EMA product number:
  EMEA/H/C/004136
• Marketing authorisation holder:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Opinion adopted:
  10/11/2016
• Marketing authorisation issued:
  18/01/2017
• Withdrawal of marketing authorisation:
  20/10/2026
• Revision:
  14

Assessment history

Changes since initial authorisation of medicine

Zinplava : EPAR - Procedural steps taken and scientific information after authorisation

Zinplava : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Zinplava-H-C-004136-II-0037 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/CHMP/534896/2023

CHMP post-authorisation summary of positive opinion for Zinplava (II-37)

Adopted Reference Number: EMA/CHMP/534898/2023

Zinplava-H-C-004136-P46-004 : EPAR - Assessment report

Adopted Reference Number: EMA/106143/2023

Initial marketing authorisation documents

Zinplava : EPAR - Public assessment report

Adopted Reference Number: EMA/853812/2016

CHMP summary of positive opinion for Zinplava

Adopted Reference Number: EMA/CHMP/714398/2016