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

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pandemic influenza vaccine (H5N1) (live attenuated, nasal)

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 10/05/2019

Authorisation details

Product details
Name
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
Agency product number
EMEA/H/C/003963
Active substance
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
International non-proprietary name (INN) or common name
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Therapeutic area (MeSH)
Influenza, Human
Anatomical therapeutic chemical (ATC) code
J07BB03
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
AstraZeneca AB
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
20/05/2016
Contact address
5E-151 85 Sodertalje
Sweden

Product information

28/03/2019 Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) - EMEA/H/C/003963 - IB/0023

Contents

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Pharmacotherapeutic group

Vaccines

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

Assessment history

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