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 01/08/2018

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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
4
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

15/06/2018 Zinplava - EMEA/H/C/004136 - T/0011

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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