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.
Therapeutic Indication
### Therapeutic indication Prophylaxis of influenza in adults and children from 2 years of age. Flucelvax Tetra should be used in accordance with official recommendations.
Therapeutic Area (MeSH)
ATC Code
J07BB02
ATC Item
influenza, inactivated, split virus or surface antigen
Pharmacotherapeutic Group
influenza, inactivated, split virus or surface antigen
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| 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) | N/A | a/wisconsin/67/2022 (h 1 n 1)pdm 09-like strain (a/georgia/12/2022, cvr-167) a/massachusetts/18/2022 (h 3 n 2)-like strain (a/sydney/1304/2022, wild type) b/austria/1359417/2021-like strain (b/singapore/wuh 4618/2021, wild type) b/phuket/3073/2013-like strain (b/singapore/inftt-16-0610/2016, wild type) |
EMA Name
Flucelvax Tetra
Medicine Name
Flucelvax Tetra
Aliases
N/A
