Nimenrix

meningococcal group A, C, W 135 and Y conjugate vaccine

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This is a summary of the European public assessment report (EPAR) for Nimenrix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Nimenrix.

What is Nimenrix?

Nimenrix is a vaccine. It is a powder and solvent that are mixed together to make a solution for injection. The powder is available in a vial, and the solvent is available in a pre-filled syringe or in an ampoule (a sealed container). It contains parts of the bacterium Neisseria meningitidis (N. meningitidis).

What is Nimenrix used for?

Nimenrix is used to protect adults, adolescents and children from the age of 12 months against invasive meningococcal disease caused by four groups of the bacterium N. meningitidis (A, C, W-135, and Y). Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).

The vaccine can only be obtained with a prescription.

How is Nimenrix used?

Nimenrix should be used according to available official recommendations.

Nimenrix is given as a single injection, preferably into the shoulder muscle. It can be given into the thigh muscle in children under two years old. Nimenrix may also be used as a booster vaccine in people who have already been vaccinated with a plain unconjugated polysaccharide vaccine, to reinforce the level of protection.

How does Nimenrix work?

Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. When a person is given the vaccine, the immune system recognises the parts of the bacterium contained in the vaccine as ‘foreign’ and makes antibodies against them. When the person is then exposed to the bacterium, these antibodies together with other components of the immune system will be able to kill the bacteria and help protect against the disease.

Nimenrix contains small amounts of polysaccharides (sugars) extracted from the four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified and then ‘conjugated’ (attached) to a protein carrier called tetanus toxoid (a weakened toxin of tetanus which does not cause disease, also used in tetanus vaccine), because this improves the immune response to the vaccine.

How has Nimenrix been studied?

The ability of Nimenrix to trigger the production of antibodies (immunogenicity) was assessed in five main studies involving over 4,000 participants. Nimenrix was compared with several other similar vaccines against N. meningitidis in people of different age groups from 12 months and above. The main measure of effectiveness was whether Nimenrix was as good as the comparator vaccines at stimulating an immune response against the four types of N. meningitidis polysaccharides showing an ability to kill the bacteria.

What benefit has Nimenrix shown during the studies?

The studies showed that Nimenrix was as effective as the comparator vaccines in stimulating an immune response against all four types of N. meningitidis polysaccharides in people of different age groups. The number of people who had an immune response against the polysaccharides with Nimenrix was similar to the comparator vaccines. The studies also showed that when Nimenrix is given to people who have already been vaccinated with a plain unconjugated polysaccharide vaccine it increased the production of antibodies, although less so than when given to previously unvaccinated people.

What is the risk associated with Nimenrix?

The most common side effects with Nimenrix (seen in more than 1 patient in 10) are loss of appetite, irritability, drowsiness, headache, fever, swelling, pain and redness at the site of injection, and fatigue (tiredness). For the full list of all side effects and restrictions with Nimenrix, see the package leaflet.

Why has Nimenrix been approved?

The CHMP considered that Nimenrix had been shown to be at least as effective as comparable vaccines at stimulating an immune response to the four groups of the N. meningitidis bacterium in people of different age groups. The Committee noted that Nimenrix offered the benefits of conjugated vaccines over conventional vaccines, including producing a strong immune response in young children. Nimenrix is well tolerated and the CHMP considered that it can be safely given together with other routinely used vaccines in the different age groups. Therefore, the CHMP decided that the benefits of Nimenrix are greater than its risks and recommended that it be granted marketing authorisation.

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

A risk management plan has been developed to ensure that Nimenrix is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nimenrix, including the appropriate precautions to be followed by healthcare professionals and patients.

What information is still awaited for Nimenrix?

The company that makes Nimenrix will carry out a study to assess how long the protective immune response provided by one or two doses of Nimenrix lasts in young children under two years old.

Other information about Nimenrix

The European Commission granted a marketing authorisation valid throughout the European Union for Nimenrix on 20 April 2012.

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

Name Language First published Last updated
Nimenrix : EPAR - Summary for the public BG = bălgarski 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public ES = español 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public CS = čeština 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public DA = dansk 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public DE = Deutsch 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public ET = eesti keel 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public EL = elliniká 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public EN = English 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public FR = français 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public IT = italiano 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public LV = latviešu valoda 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public LT = lietuvių kalba 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public HU = magyar 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public MT = Malti 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public NL = Nederlands 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public PL = polski 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public PT = português 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public RO = română 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public SK = slovenčina 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public SL = slovenščina 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public FI = suomi 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public SV = svenska 24/05/2012 05/01/2016
Nimenrix : EPAR - Summary for the public HR = Hrvatski 24/05/2012 05/01/2016

This EPAR was last updated on 12/02/2016 .

Authorisation details

Product details

Product details for Nimenrix
NameNimenrix
Agency product numberEMEA/H/C/002226
Active substance

Neisseria meningitidis serogroup A polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup C polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup W-135 polysaccharide conjugated to tetanus toxoid / Neisseria meningitidis serogroup Y polysaccharide conjugated to tetanus toxoid

International non-proprietary name (INN) or common name

meningococcal group A, C, W 135 and Y conjugate vaccine

Therapeutic area Meningitis, Meningococcal
Anatomical therapeutic chemical (ATC) code J07AH08
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 Nimenrix
Marketing-authorisation holder

Pfizer Limited

Revision12
Date of issue of marketing authorisation valid throughout the European Union20/04/2012

Contact address:

Pfizer Limited
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

Product information

15/01/2016  Nimenrix -EMEA/H/C/002226 -IAIN/0052

Name Language First published Last updated
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016
Nimenrix : EPAR - Product Information HR = Hrvatski 24/05/2012 09/02/2016

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
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  
Nimenrix : EPAR - All Authorised presentations HR = Hrvatski 24/05/2012  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Nimenrix is indicated for active immunisation of individuals from the age of 12 months and above against invasive meningococcal diseases caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Nimenrix : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 24/06/2013 09/02/2016
Nimenrix-H-C-2226-P46-0048 : EPAR - Assessment Report - Variation HR = Hrvatski 12/02/2016  
Nimenrix-H-C-2226-P46-0044 : EPAR - Assessment Report HR = Hrvatski 14/12/2015  
Nimenrix-H-C-2226-P46-0041 : EPAR - Assessment Report HR = Hrvatski 27/03/2015  
Nimenrix-H-C-2226-PSUV-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 11/08/2014  
Nimenrix-H-C-2226-P46-0034-0035 : EPAR - Assessment Report HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-II-0016 : EPAR - Assessment Report - Variation HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-P46-0020 : EPAR - Assessment Report HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-P46-0018 : EPAR - Assessment Report HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-II-0009 : EPAR - Assessment Report - Variation HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-P46-0037 : EPAR - Assessment Report HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-P46-0036 : EPAR - Assessment Report HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-P46-0038 : EPAR - Assessment Report HR = Hrvatski 04/04/2014  
Nimenrix-H-C-2226-P46-0008-0014 : EPAR - Assessment Report HR = Hrvatski 24/06/2013  
Nimenrix-H-C-2226-P46-0017 : EPAR - Assessment Report HR = Hrvatski 24/06/2013  
Nimenrix-H-C-2226-P46-0015-0016 : EPAR - Assessment Report HR = Hrvatski 24/06/2013  

Initial marketing-authorisation documents

Name Language First published Last updated
Nimenrix : EPAR - Public assessment report HR = Hrvatski 24/05/2012  
CHMP summary of positive opinion for Nimenrix HR = Hrvatski 17/02/2012  

Authorised

This medicine is approved for use in the European Union