Fluenz Tetra

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (live attenuated, nasal)

Overview

On 14 July 2025, the European Commission withdrew the marketing authorisation for Fluenz Tetra (influenza vaccine (live attenuated, nasal)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Fluenz Tetra was granted marketing authorisation in the EU on 4 December 2013 for prophylaxis of influenza in individuals 24 months to less than 18 years of age.

The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2018.

Fluenz Tetra : EPAR - Summary for the public

Fluenz Tetra : EPAR - Risk-management-plan

Product information

Fluenz Tetra : EPAR - Product Information

Fluenz Tetra : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Fluenz Tetra
• Active substance:
  A/Darwin/9/2021 (H3N2) - like strain (A/Norway/16606/2021, MEDI 355293) / A/Victoria/2570/2019 (H1N1)pdm09 - like strain (A/Victoria/1/2020, MEDI 340505) / B/Austria/1359417/2021 - like strain (B/Austria/1359417/2021, MEDI 355292) / B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, MEDI 306444)
• International non-proprietary name (INN) or common name:
  influenza vaccine (live attenuated, nasal)
• Therapeutic area (MeSH):
  Influenza, Human
• Anatomical therapeutic chemical (ATC) code:
  J07BB03

Pharmacotherapeutic group

• Influenza vaccines
• Influenza, live attenuated

Therapeutic indication

Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. The use of Fluenz Tetra should be based on official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/002617
• Marketing authorisation holder:
  AstraZeneca AB

  SE-151 85 Södertälje; Sweden

• Opinion adopted:
  19/09/2013
• Marketing authorisation issued:
  04/12/2013
• Withdrawal of marketing authorisation:
  14/07/2025
• Revision:
  24

Assessment history

Changes since initial authorisation of medicine

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

Fluenz Tetra-H-C-2617-P46-009 : EPAR - Assessment Report

Adopted Reference Number: EMA/CHMP/657099/2015

Initial marketing authorisation documents

Fluenz Tetra : EPAR - Public assessment report

Adopted Reference Number: EMA/586629/2013

CHMP summary of opinion for Fluenz Tetra

Adopted Reference Number: EMA/CHMP/547873/2013