Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Adjupanrix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Adjupanrix.
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Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals): EPAR - Summary for the public (PDF/53.5 KB)
First published: 17/12/2009
Last updated: 24/01/2013 -
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Adjupanrix : EPAR - Risk-management-plan summary (PDF/179.76 KB)
First published: 06/11/2019
Authorisation details
Product details | |
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Name |
Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals)
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Agency product number |
EMEA/H/C/001206
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Active substance |
split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
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International non-proprietary name (INN) or common name |
pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
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Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
J07BB02
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Exceptional circumstances |
This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance. |
Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
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Revision |
11
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Date of issue of marketing authorisation valid throughout the European Union |
10/10/2009
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Contact address |
89, rue de l'Institut
BE-1330 Rixensart Belgium |
Product information
24/05/2022 Adjupanrix (previously Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals) - EMEA/H/C/001206 - II/0074
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. Pandemic influenza vaccine should be used in accordance with official guidance.