Fluad Tetra

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (surface antigen, inactivated, adjuvanted)

Overview

On 23 February 2026, the European Commission withdrew the marketing authorisation for Fluad Tetra (influenza vaccine (surface antigen, inactivated, adjuvanted)) 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. 

Fluad Tetra was granted marketing authorisation in the EU on 20 May 2020. The authorised indication was prophylaxis of influenza in adults 50 years of age and older. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2024.

Fluad Tetra : EPAR - Medicine overview

Reference Number: EMA/516573/2023

Fluad Tetra : EPAR - Risk management plan

Product information

Fluad Tetra : EPAR - Product information

Fluad Tetra : EPAR - All authorised presentations

Product details

• Name of medicine:
  Fluad Tetra
• Active substance:
  A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022, IVR-238) / A/Thailand/8/2022 (H3N2)-like strain (A/Thailand/8/2022 IVR-237) / B/Austria/1359417/2021-like strain (B/Austria/1359417/2021, BVR-26) / B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, BVR-1B) influenza virus
• International non-proprietary name (INN) or common name:
  influenza vaccine (surface antigen, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in adults 50 years of age and older.

Fluad Tetra should be used in accordance with official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/004993
• Marketing authorisation holder:
  Seqirus Netherlands B.V.

  Paasheuvelweg 28; 1105 BJ Amsterdam; The Netherlands

• Opinion adopted:
  26/03/2020
• Marketing authorisation issued:
  20/05/2020
• Withdrawal of marketing authorisation:
  23/02/2026
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

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

Fluad Tetra-H-C-004993-II-0043 : EPAR - Assessment report - Variation

Adopted Reference Number: EMA/533902/2023

CHMP summary of positive opinion for Fluad Tetra (II-43)

Adopted Reference Number: EMA/CHMP/492465/2023

Initial marketing authorisation documents

Fluad Tetra : EPAR - Public assessment report

Adopted Reference Number: EMA/200444/2020

CHMP summary of positive opinion for Fluad Tetra

Adopted Reference Number: EMA/CHMP/132960/2020