This is a summary of the European public assessment report (EPAR) for Fluenz Tetra. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Fluenz Tetra. For practical information about using Fluenz Tetra, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### 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.
Therapeutic Area (MeSH)
ATC Code
J07BB03
ATC Item
influenza, live attenuated
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| 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) | N/A | a/darwin/9/2021 (h 3 n 2) - like strain (a/norway/16606/2021, medi 355293) / a/victoria/2570/2019 (h 1 n 1)pdm 09 - 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) |
EMA Name
Fluenz Tetra
Medicine Name
Fluenz Tetra
Aliases
N/ANo risk management plan link.
