Zinplava

RSS

bezlotoxumab

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Zinplava. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zinplava.

For practical information about using Zinplava, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 18/11/2022

Authorisation details

Product details
Name
Zinplava
Agency product number
EMEA/H/C/004136
Active substance
bezlotoxumab
International non-proprietary name (INN) or common name
bezlotoxumab
Therapeutic area (MeSH)
Enterocolitis, Pseudomembranous
Anatomical therapeutic chemical (ATC) code
J06BB21
Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
18/01/2017
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

18/11/2022 Zinplava - EMEA/H/C/004136 - IAIN/0035/G

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

Related content

How useful was this page?

Add your rating