Is Bezlotoxumab approved by the US FDA?

Drugs@FDA lists 1 application product line for Bezlotoxumab, including ZINPLAVA (Prescription).

Is Bezlotoxumab authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Bezlotoxumab: Zinplava.

Are there safety signals or safety updates for Bezlotoxumab?

US FDA: 1 entry (latest 2023-05-26).

Active substance

Bezlotoxumab

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZINPLAVA	1000ML/40ML	injectable · injection	MERCK SHARP DOHME	Prescription	21 Oct 2016

EMA European Union — centrally authorised medicines

Zinplava Merck Sharp & Dohme B.V. · Authorised · authorised 18 Jan 2017 · ATC J06BB21

Therapeutic indication (EMA)

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

Safety signals and safety-related labeling changes

US FDA 26 May 2023 ZINPLAVA — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for bezlotoxumab →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.