Trumenba
meningococcal group b vaccine (recombinant, adsorbed)
Table of contents
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.
-
List item
Trumenba : EPAR - Summary for the public (PDF/77.17 KB)
First published: 06/06/2017
Last updated: 06/06/2017
EMA/208531/2017 -
-
List item
Trumenba : EPAR Risk-management-plan summary (PDF/156.9 KB)
First published: 22/01/2019
Last updated: 02/12/2022
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Pfizer Europe MA EEIG
|
Revision |
14
|
Date of issue of marketing authorisation valid throughout the European Union |
24/05/2017
|
Contact address |
Boulevard de la Plaine 17 |
Product information
23/11/2022 Trumenba - EMEA/H/C/004051 - IB/0043
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.