Trumenba

RSS

meningococcal group b vaccine (recombinant, adsorbed)

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

Overview

This is a summary of the European public assessment report (EPAR) for Trumenba. 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 Trumenba.

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

This EPAR was last updated on 15/05/2018

Authorisation details

Product details
Name
Trumenba
Agency product number
EMEA/H/C/004051
Active substance
Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily A; Neisseria meningitidis serogroup B fHbp (recombinant lipidated fHbp (factor H binding protein)) subfamily B
International non-proprietary name (INN) or common name
meningococcal group b vaccine (recombinant, adsorbed)
Therapeutic area (MeSH)
Meningitis, Meningococcal
Anatomical therapeutic chemical (ATC) code
J07AH09
Additional 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
Pfizer Limited
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
24/05/2017
Contact address
821 Ramsgate Road Sandwich
Kent CT13 9NJ
United Kingdom

Product information

11/04/2018 Trumenba - EMEA/H/C/004051 - IAIN/0007/G

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.

Pharmacotherapeutic group

  • BACTERIAL VACCINES
  • Meningococcal vaccines

Therapeutic indication

Trumenba is indicated for active immunisation of individuals 10 years and older to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

The use of this vaccine should be in accordance with official recommendations.

Assessment history

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