Pandemrix
influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Table of contents
Overview
The marketing authorisation for Pandemrix has expired following the marketing-authorisation holder’s decision not to apply for a renewal.
Authorisation details
Product details | |
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Name |
Pandemrix
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Agency product number |
EMEA/H/C/000832
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Active substance |
split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
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International non-proprietary name (INN) or common name |
influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
J07BB02
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Publication details | |
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Marketing-authorisation holder |
GlaxoSmithKline Biologicals S.A.
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Revision |
23
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Date of issue of marketing authorisation valid throughout the European Union |
20/05/2008
|
Contact address |
Rue de l'Institut, 89
B-1330 Rixensart Belgium |
Product information
28/04/2016 Pandemrix - EMEA/H/C/000832 - II/0079
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
Therapeutic indication
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).
Pandemrix should be used in accordance with Official Guidance.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 201219/10/2012
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19/10/2012
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21/07/2011
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15/04/2011
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European Medicines Agency reviews further data on narcolepsy and possible association with Pandemrix18/02/2011
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23/09/2010
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08/09/2010
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03/09/2010
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27/08/2010
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22/01/2010
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04/12/2009
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20/11/2009
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20/11/2009
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25/09/2009