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.
Therapeutic Indication
### Therapeutic indication Prophylaxis of influenza in adults 50 years of age and older. Fluad 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
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| 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 | N/A | a/victoria/4897/2022 (h 1 n 1)pdm 09-like strain (a/victoria/4897/2022, ivr-238) / a/thailand/8/2022 (h 3 n 2)-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-1 b) influenza virus |
EMA Name
Fluad Tetra
Medicine Name
Fluad Tetra
Aliases
N/A
