Flucelvax Tetra

influenza vaccine surface antigen inactivated prepared in cell cultures

Table of contents

Opinion

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Flucelvax Tetra. The marketing authorisation holder for this medicinal product is Seqirus Netherlands B.V.

The CHMP adopted an extension to the existing indication as follows:1

Prophylaxis of influenza in adults and children from 9 2 years of age.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1New text in bold, removed text as strikethrough

Key facts

Name
Flucelvax Tetra
Agency product number
EMEA/H/C/004814
International non-proprietary name (INN) or common name
  • influenza vaccine surface antigen inactivated prepared in cell cultures
Active substance
  • Influenza virus surface antigens (haemagglutinin and neuraminidase)* , inactivated, of the following strains: A/xxxxx (H3N2)-like strain (reassortant used)/ A/xxxxx H1N1- like strain (reassortant used)/ B/xxxxx (Yamagata Lineage) – like strain (reassortant used)/ B/xxxxx (Victoria Lineage) – like strain (reassortant used)
Therapeutic area
Influenza, Human
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.

Date opinion adopted
17/09/2020
Company name
Seqirus Netherlands B.V.
Status
Positive
Application type
Post-authorisation

How useful was this page?

Add your rating