Arepanrix

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Withdrawn

This medicine's authorisation has been withdrawn

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On the 23 March 2010 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Arepanrix, pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted), which had been approved for prophylaxis of influenza in an officially declared pandemic situation. 

The marketing authorisation holder (MAH) responsible for Arepanrix was GlaxoSmithKline Biologicals S.A. The European Commission was notified by a letter dated 22 November 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Arepanrix for commercial reasons. Arepanrix was not marketed in any European country. 

On 13 December 2010 the European Commission issued a decision to withdraw the marketing authorisation for Arepanrix. Pursuant to this decision the European Public Assessment Report for Arepanrix is updated to reflect that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IB/0005/G
13/08/2010
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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).

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Product details

Name of medicine
Arepanrix
Active substance
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.
International non-proprietary name (INN) or common name
pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance

Authorisation details

EMA product number
EMEA/H/C/001201

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.

Marketing authorisation holder
GlaxoSmithKline Biologicals S.A.

89, rue de l'Institut
BE-1330 Rixensart
Belgium

Marketing authorisation issued
23/03/2010
Withdrawal of marketing authorisation
13/12/2010
Revision
1

Assessment history

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