Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
Table of contents
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.
Authorisation details
Product details | |
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Name |
Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune)
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Agency product number |
EMEA/H/C/003963
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Active substance |
reassortant influenza virus (live attenuated) of the following strain: A/Vietnam/1203/2004 (H5N1) strain
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International non-proprietary name (INN) or common name |
pandemic influenza vaccine (H5N1) (live attenuated, nasal)
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Therapeutic area (MeSH) |
Influenza, Human
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Anatomical therapeutic chemical (ATC) code |
J07BB03
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Additional 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 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 | |
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Marketing-authorisation holder |
AstraZeneca AB
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Revision |
9
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Date of issue of marketing authorisation valid throughout the European Union |
20/05/2016
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Contact address |
5E-151 85 Sodertalje
Sweden |
Product information
04/10/2022 Pandemic influenza vaccine H5N1 AstraZeneca (previously Pandemic influenza vaccine H5N1 Medimmune) - EMEA/H/C/003963 - IB/0054
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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