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EMA Product

Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)

Product approved by European Medicines Agency (EU)

Basic Information

Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)

Regulatory Information

EMEA/H/C/003963

Authorised

May 20, 2016

March 31, 2016

11

March 19, 2025

Company Information

Sweden

5E-151 85 Sodertalje

ASTRAZENECA AB

Drug Classification

Conditional ApprovalAdditional Monitoring

Active Substances Detail

reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain

Detailed Information

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

Overview Summary

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.

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