Flucelvax Tetra

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Overview

On 23 February 2026, the European Commission withdrew the marketing authorisation for Flucelvax Tetra (influenza vaccine (surface antigen, inactivated, prepared in cell cultures)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Seqirus Netherlands B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Flucelvax Tetra was granted marketing authorisation in the EU on 12 December 2018. The authorised indication was prophylaxis of influenza in adults and children from 6 months of age.

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2023.

Flucelvax Tetra : EPAR - Medicine overview

Reference Number: EMA/2412/2025

Flucelvax Tetra : EPAR - Risk management plan

Product information

Flucelvax Tetra : EPAR - Product Information

Flucelvax Tetra : EPAR - All authorised presentations

Product details

• Name of medicine:
  Flucelvax Tetra
• Active substance:
  A/Wisconsin/67/2022 (H1N1)pdm09-like strain (A/Georgia/12/2022, CVR-167) A/Massachusetts/18/2022 (H3N2)-like strain (A/Sydney/1304/2022, wild type) B/Austria/1359417/2021-like strain (B/Singapore/WUH4618/2021, wild type) B/Phuket/3073/2013-like strain (B/Singapore/INFTT-16-0610/2016, wild type)
• International non-proprietary name (INN) or common name:
  influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

influenza, inactivated, split virus or surface antigen

Therapeutic indication

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

Flucelvax Tetra should be used in accordance with official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/004814
• Marketing authorisation holder:
  Seqirus Netherlands B.V.

  Paasheuvelweg 28; 1105 BJ Amsterdam; The Netherlands

• Opinion adopted:
  18/10/2018
• Marketing authorisation issued:
  12/12/2018
• Withdrawal of marketing authorisation:
  23/02/2026
• Revision:
  17

Assessment history

Changes since initial authorisation of medicine

Flucelvax Tetra : EPAR - Procedural steps taken and scientific information after the authorisation

Flucelvax Tetra-H-C-4814-II-0047 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/19181/2025

CHMP post-authorisation summary of positive opinion for Flucelvax Tetra (II-47)

Adopted Reference Number: EMA/CHMP/559432/2024

Flucelvax Tetra-H-C-4814-P46-007 : EPAR - Assessment Report

Adopted Reference Number: EMA/318515/2021

Flucelvax Tetra-H-C-4814-II-013 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/276144/2020

CHMP post-authorisation summary of positive opinion for Flucelvax Tetra (II-13)

Adopted Reference Number: EMA/CHMP/316963/2020

Initial marketing authorisation documents

Flucelvax Tetra : EPAR - Public assessment report

Adopted Reference Number: EMA/814746/2018

CHMP summary of positive opinion for Flucelvax Tetra

Adopted Reference Number: EMA/CHMP/641495/2018