This is a summary of the European public assessment report (EPAR) for Pandemic influenza vaccine H5N1 AstraZeneca. 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 Pandemic influenza vaccine H5N1 AstraZeneca. For practical information about using Pandemic influenza vaccine H5N1 AstraZeneca, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic indication Prophylaxis of influenza in an officially declared pandemic situation in children and adolescents from 12 months to less than 18 years of age. Pandemic influenza vaccine H5N1 AstraZeneca should be used in accordance with official guidance
Therapeutic Area (MeSH)
ATC Code
J07BB03
ATC Item
influenza, live attenuated
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain | N/A | reassortant influenza virus (live attenuated) of the following strain: a/vietnam/1203/2004 (h 5 n 1) strain |
EMA Name
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
Medicine Name
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
Aliases
N/ANo risk management plan link.