Zinplava

bezlotoxumab

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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.

What is Zinplava and what is it used for?

Zinplava is a medicine used in adults who have infections due to bacteria called Clostridium difficile that cause severe diarrhoea. It is used to prevent future episodes of diarrhoea in patients who are taking antibiotics to treat their C. difficile infection and who are at high risk of the infection coming back.

How is Zinplava used?

Zinplava is available as a concentrate to be made into a solution for infusion (drip) into a vein. It is given as a single infusion lasting around 1 hour. The recommended dose is 10 mg per kilogram bodyweight.

The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Zinplava work?

C. difficile bacteria produce toxins that damage the lining of the gut causing diarrhoea which may be severe. After an initial infection, some dormant forms of the bacteria (spores) may persist in the body and eventually produce further toxins, causing the symptoms to return. Bezlotoxumab is a monoclonal antibody (a type of protein) that has been designed to attach to these toxins, blocking their action, thereby preventing further damage and diarrhoea from occurring.

What benefits of Zinplava have been shown in studies?

Zinplava given during antibiotic treatment was shown to be more effective than placebo (a dummy treatment) at preventing a new episode of diarrhoea caused by C. difficile infection in 2 main studies involving a total of 2,655 patients. A new episode of diarrhoea was defined as 3 or more loose stools in 24 or fewer hours.

In the first study, 17% of patients given Zinplava (67 out of 386) had a new episode of diarrhoea in the 12 weeks after treatment compared with 28% of patients given placebo (109 out of 395). In the second study, figures were 16% (62 out of 395) for Zinplava and 26% (97 out of 378) for placebo. The effect was mainly seen in patients at higher risk of C. difficile infection coming back (such as older patients or those with a weakened immune system).

What are the risks associated with Zinplava?

The most common side effects with Zinplava (seen in more than 4 in 100 patients) are nausea (feeling sick), diarrhoea, fever and headache. Similar effects have been seen in patients on placebo.

For the full list of all side effects and restrictions with Zinplava, see the package leaflet.

Why is Zinplava approved?

Zinplava has been shown to be effective at preventing recurrence of C. difficile infection, particularly in patients at high risk of the infection coming back (which occurs in about 15 to 35% of cases and is particularly difficult to treat). Zinplava is generally well tolerated with side effects similar to those observed in patients on placebo.

The Agency’s Committee for Medicinal Products for Human Use (CHMP) therefore decided that Zinplava’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Zinplava?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zinplava have been included in the summary of product characteristics and the package leaflet.

Other information about Zinplava

The European Commission granted a marketing authorisation valid throughout the European Union for Zinplava on 18 January 2017.

For more information about treatment with Zinplava, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Zinplava : EPAR - Summary for the public BG = bălgarski 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public ES = español 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public CS = čeština 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public DA = dansk 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public DE = Deutsch 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public ET = eesti keel 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public EL = elliniká 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public EN = English 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public FR = français 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public IT = italiano 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public LV = latviešu valoda 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public LT = lietuvių kalba 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public HU = magyar 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public MT = Malti 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public NL = Nederlands 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public PL = polski 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public PT = português 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public RO = română 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public SK = slovenčina 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public SL = slovenščina 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public FI = suomi 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public SV = svenska 2017-03-08 2017-03-23
Zinplava : EPAR - Summary for the public HR = Hrvatski 2017-03-08 2017-03-23

This EPAR was last updated on 08/03/2017 .

Authorisation details

Product details

Product details for Zinplava
NameZinplava
Agency product numberEMEA/H/C/004136
Active substance

bezlotoxumab

International non-proprietary name (INN) or common name

bezlotoxumab

Therapeutic area Enterocolitis, Pseudomembranous
Anatomical therapeutic chemical (ATC) code J06BB21
Additional monitoring

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

Publication details

Publication details for Zinplava
Marketing-authorisation holder

Merck Sharp & Dohme Limited

Revision0
Date of issue of marketing authorisation valid throughout the European Union18/01/2017

Contact address:

Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon
Hertfordshire
EN11 9BU
United Kingdom

Product information

Product information

18/01/2017  Zinplava -EMEA/H/C/004136 --

Name Language First published Last updated
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  
Zinplava : EPAR - Product Information HR = Hrvatski 2017-03-08  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

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.


Name Language First published Last updated
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  
Zinplava : EPAR - All Authorised presentations HR = Hrvatski 2017-03-08  

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

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Zinplava : EPAR - Public assessment report HR = Hrvatski 2017-03-08  
CHMP summary of positive opinion for Zinplava HR = Hrvatski 2016-11-23  

Authorised

This medicine is approved for use in the European Union