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

What is Nimenrix and what is it used for?

Nimenrix is a vaccine used to protect adults, adolescents and children from the age of 6 weeks against invasive meningococcal disease caused by four groups of the bacterium Neisseria meningitidis (group 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 poisoning).
The vaccine contains substances from the outer coat of the bacterium N. meningitidis.

How is Nimenrix used?

Nimenrix can only be obtained with a prescription and should be used according to available official recommendations. It is available as 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).


Nimenrix is given as an injection into the thigh or shoulder muscle. In children from 6 to 12 weeks of age, three doses of Nimenrix are recommended (the first dose is given from 6 weeks of age, the second dose 2 months afterwards, and the third booster dose at 1 year of age). In adults and children from 1 year of age, one injection is usually given. Nimenrix may also be used as a booster vaccine in people from 1 year of age who have already been vaccinated with Nimenrix or another meningococcal vaccine, to reinforce the level of protection.

For further information, see the package leaflet.

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 ready to kill the bacteria and help protect against the disease.
Nimenrix contains small amounts of capsular polysaccharides (sugars from the outer coat) 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.

What benefits of Nimenrix have been shown in studies?

The ability of Nimenrix to trigger the production of antibodies (immunogenicity) was assessed in five main studies involving over 4,000 participants aged 1 year or more. Nimenrix was compared with several other similar vaccines against N. meningitidis. Results showed that a single injection of Nimenrix was as effective as the other vaccines in stimulating an immune response against all four types of N. meningitidis polysaccharides. The number of people who had an immune response against the polysaccharides with Nimenrix was similar to the other vaccines.
Studies also showed that, in people vaccinated with Nimenrix or another meningococcal vaccine when they were 1 year of age or older, Nimenrix given as a booster several years after they had been vaccinated increased the level of antibodies.
A sixth study in over 2,000 children first vaccinated between 6 and 12 weeks of age showed that Nimenrix (given as 2 doses 2 months apart) was as effective as two other vaccines against N. meningitides in stimulating an immune response.

What are the risks associated with Nimenrix?

The most common side effects from initial vaccination 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 tiredness. Side effects after booster vaccination with Nimenrix are generally similar to those after initial vaccination, but diarrhoea, vomiting and nausea are also very common. For the full list of all side effects and restrictions with Nimenrix, see the package leaflet.

Why is Nimenrix 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?

The company that markets 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 between 1 and 2 years old.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nimenrix have also been included in the summary of product characteristics and the package leaflet.

Other information about Nimenrix

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

Name Language First published Last updated
Nimenrix : EPAR - Summary for the public BG = bălgarski 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public ES = español 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public CS = čeština 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public DA = dansk 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public DE = Deutsch 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public ET = eesti keel 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public EL = elliniká 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public EN = English 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public FR = français 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public IT = italiano 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public LV = latviešu valoda 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public LT = lietuvių kalba 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public HU = magyar 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public MT = Malti 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public NL = Nederlands 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public PL = polski 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public PT = português 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public RO = română 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public SK = slovenčina 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public SL = slovenščina 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public FI = suomi 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public SV = svenska 2012-05-24 2017-01-31
Nimenrix : EPAR - Summary for the public HR = Hrvatski 2012-05-24 2017-01-31

This EPAR was last updated on 31/03/2017 .

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

Publication details

Publication details for Nimenrix
Marketing-authorisation holder

Pfizer Limited

Revision17
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

16/02/2017  Nimenrix -EMEA/H/C/002226 -R/0059

Name Language First published Last updated
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31
Nimenrix : EPAR - Product Information HR = Hrvatski 2012-05-24 2017-03-31

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

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Nimenrix is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group 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 2013-06-24 2017-03-31
Nimenrix-H-C-2226-II-0049 : EPAR - Assessment Report - Variation HR = Hrvatski 2017-01-31  
CHMP post-authorisation summary of positive opinion for Nimenrix HR = Hrvatski 2016-11-11  
Nimenrix-H-C-2226-P46-0048 : EPAR - Assessment Report - Variation HR = Hrvatski 2016-02-12  
Nimenrix-H-C-2226-P46-0044 : EPAR - Assessment Report HR = Hrvatski 2015-12-14  
Nimenrix-H-C-2226-P46-0041 : EPAR - Assessment Report HR = Hrvatski 2015-03-27  
Nimenrix-H-C-2226-PSUV-0020 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation HR = Hrvatski 2014-08-11  
Nimenrix-H-C-2226-P46-0034-0035 : EPAR - Assessment Report HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-II-0016 : EPAR - Assessment Report - Variation HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-P46-0036 : EPAR - Assessment Report HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-P46-0018 : EPAR - Assessment Report HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-P46-0037 : EPAR - Assessment Report HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-P46-0020 : EPAR - Assessment Report HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-P46-0038 : EPAR - Assessment Report HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-II-0009 : EPAR - Assessment Report - Variation HR = Hrvatski 2014-04-04  
Nimenrix-H-C-2226-P46-0008-0014 : EPAR - Assessment Report HR = Hrvatski 2013-06-24  
Nimenrix-H-C-2226-P46-0015-0016 : EPAR - Assessment Report HR = Hrvatski 2013-06-24  
Nimenrix-H-C-2226-P46-0017 : EPAR - Assessment Report HR = Hrvatski 2013-06-24  

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union