Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Seqirus Netherlands B.V., Paasheuvelweg 28, 1105 BJ Amsterdam, The Netherlands
Fluad Tetra, suspension for injection in pre-filled syringe.
Influenza vaccine (surface antigen, inactivated, adjuvanted).
| Pharmaceutical Form |
|---|
|
Suspension for injection in pre-filled syringe (injection). Milky-white suspension. |
Influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains*:
| Per 0.5 ml dose | |
|---|---|
| A/Victoria/4897/2022 (H1N1)pdm09-like strain (A/Victoria/4897/2022 IVR-238) | 15 micrograms HA** |
| A/Darwin/9/2021 (H3N2) -like strain (A/Darwin/6/2021 IVR-227) | 15 micrograms HA** |
| B/Austria/1359417/2021-like strain (B/Austria/1359417/2021 BVR-26) | 15 micrograms HA** |
| B/Phuket/3073/2013-like strain (B/Phuket/3073/2013 BVR‐1B) | 15 micrograms HA** |
* propagated in fertilised hens' eggs from healthy chicken flocks and adjuvanted with MF59C.1
** haemagglutinin
Adjuvant MF59C.1 containing per 0.5 ml dose: squalene (9.75 mg), polysorbate 80 (1.175 mg), sorbitan trioleate (1.175 mg), sodium citrate (0.66 mg) and citric acid (0.04 mg).
This vaccine complies with the WHO recommendations (Northern Hemisphere) and EU recommendation for the 2023/2024 season.
Fluad Tetra may contain traces of eggs such as ovalbumin or chicken proteins, kanamycin and neomycin sulphate, formaldehyde, hydrocortisone, cetyltrimethylammonium bromide (CTAB) which are used during the manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Influenza, inactivated, surface antigen |
|
| List of Excipients |
|---|
|
For adjuvant: see also section 2. Sodium chloride |
0.5 ml of suspension for injection in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber), presented with or without needle.
Pack of 1 pre-filled syringe with needle
Pack of 1 pre-filled syringe without needle
Pack of 10 pre-filled syringes with needles
Pack of 10 pre-filled syringes without needles
Not all pack sizes may be marketed.
Seqirus Netherlands B.V., Paasheuvelweg 28, 1105 BJ Amsterdam, The Netherlands
EU/1/20/1433/001
EU/1/20/1433/002
EU/1/20/1433/003
EU/1/20/1433/004
Date of first authorisation: 20 May 2020
| Drug | Countries | |
|---|---|---|
| FLUAD TETRA | Austria, Estonia, Spain, France, Croatia, Ireland, Italy, Lithuania, Poland, United Kingdom |
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