- Application under evaluation
- CHMP opinion
- European Commission decision
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
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română (RO) (112.57 KB - PDF)
slovenčina (SK) (116 KB - PDF)
slovenščina (SL) (109.1 KB - PDF)
Suomi (FI) (87.61 KB - PDF)
svenska (SV) (87.82 KB - PDF)
Fluenz Tetra : EPAR - Risk-management-plan
English (EN) (124.96 KB - PDF)
Product information
Fluenz Tetra : EPAR - Product Information
English (EN) (510.21 KB - PDF)
български (BG) (513.49 KB - PDF)
español (ES) (482.68 KB - PDF)
čeština (CS) (483.58 KB - PDF)
dansk (DA) (490.69 KB - PDF)
Deutsch (DE) (480.17 KB - PDF)
eesti keel (ET) (471.23 KB - PDF)
ελληνικά (EL) (508.61 KB - PDF)
français (FR) (493.43 KB - PDF)
hrvatski (HR) (484.23 KB - PDF)
íslenska (IS) (509.7 KB - PDF)
italiano (IT) (491.78 KB - PDF)
latviešu valoda (LV) (816.05 KB - PDF)
lietuvių kalba (LT) (497.62 KB - PDF)
magyar (HU) (489.23 KB - PDF)
Malti (MT) (530.76 KB - PDF)
Nederlands (NL) (490.44 KB - PDF)
norsk (NO) (479.24 KB - PDF)
polski (PL) (489.44 KB - PDF)
português (PT) (488.92 KB - PDF)
română (RO) (496.53 KB - PDF)
slovenčina (SK) (761.79 KB - PDF)
slovenščina (SL) (752.49 KB - PDF)
Suomi (FI) (479.51 KB - PDF)
svenska (SV) (475.48 KB - PDF)
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).
Fluenz Tetra : EPAR - All Authorised presentations
English (EN) (52.88 KB - PDF)
български (BG) (96.06 KB - PDF)
español (ES) (83.86 KB - PDF)
čeština (CS) (54.45 KB - PDF)
dansk (DA) (86.17 KB - PDF)
Deutsch (DE) (60.68 KB - PDF)
eesti keel (ET) (86.94 KB - PDF)
ελληνικά (EL) (67.79 KB - PDF)
français (FR) (100.68 KB - PDF)
hrvatski (HR) (53.14 KB - PDF)
íslenska (IS) (85.3 KB - PDF)
italiano (IT) (60.53 KB - PDF)
latviešu valoda (LV) (87.55 KB - PDF)
lietuvių kalba (LT) (84.98 KB - PDF)
magyar (HU) (53.89 KB - PDF)
Malti (MT) (63.17 KB - PDF)
Nederlands (NL) (87.71 KB - PDF)
norsk (NO) (84.1 KB - PDF)
polski (PL) (85.72 KB - PDF)
português (PT) (88.11 KB - PDF)
română (RO) (67.65 KB - PDF)
slovenčina (SK) (99.29 KB - PDF)
slovenščina (SL) (83.35 KB - PDF)
Suomi (FI) (83.56 KB - PDF)
svenska (SV) (86.45 KB - PDF)
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
Fluenz Tetra : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (293.27 KB - PDF)
Fluenz Tetra-H-C-2617-P46-009 : EPAR - Assessment Report
English (EN) (287.57 KB - PDF)