Fluenz Tetra | European Medicines Agency (EMA)

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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.

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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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italiano (IT)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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English (EN)
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Product information

English (EN)
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български (BG)
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First published: 17/12/2013Last updated: 14/08/2025

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español (ES)
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čeština (CS)
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dansk (DA)
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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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íslenska (IS)
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italiano (IT)
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latviešu valoda (LV)
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lietuvių kalba (LT)
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magyar (HU)
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Malti (MT)
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Nederlands (NL)
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norsk (NO)
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polski (PL)
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português (PT)
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română (RO)
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slovenčina (SK)
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slovenščina (SL)
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Suomi (FI)
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svenska (SV)
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Latest procedure affecting product information:
EMEA/H/C/002617

14/07/2025

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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).

English (EN)
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български (BG)
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First published: 17/12/2013Last updated: 14/08/2025

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español (ES)
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First published: 17/12/2013Last updated: 14/08/2025

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čeština (CS)
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First published: 17/12/2013Last updated: 14/08/2025

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dansk (DA)
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Deutsch (DE)
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eesti keel (ET)
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ελληνικά (EL)
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français (FR)
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hrvatski (HR)
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íslenska (IS)
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italiano (IT)
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latviešu valoda (LV)
(87.55 KB – PDF)

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lietuvių kalba (LT)
(84.98 KB – PDF)

First published: 17/12/2013Last updated: 14/08/2025

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magyar (HU)
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First published: 17/12/2013Last updated: 14/08/2025

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Malti (MT)
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First published: 17/12/2013Last updated: 14/08/2025

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Nederlands (NL)
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First published: 17/12/2013Last updated: 14/08/2025

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norsk (NO)
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polski (PL)
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First published: 17/12/2013Last updated: 14/08/2025

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português (PT)
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First published: 17/12/2013Last updated: 14/08/2025

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română (RO)
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First published: 17/12/2013Last updated: 14/08/2025

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slovenčina (SK)
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First published: 17/12/2013Last updated: 14/08/2025

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slovenščina (SL)
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Suomi (FI)
(83.56 KB – PDF)

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svenska (SV)
(86.45 KB – PDF)

First published: 17/12/2013Last updated: 14/08/2025

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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.

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