Arepanrix

Withdrawn

This medicine's authorisation has been withdrawn

pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

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decision the European Public Assessment Report for Arepanrix is updated to reflect that the marketing authorisation is no longer valid.

Arepanrix : EPAR - Summary for the public

Product information

Arepanrix : EPAR - Product Information

Arepanrix : EPAR - All Authorised presentations

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.

  Rue de l'Institut, 89; B-1330 Rixensart; Belgium

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

Assessment history

Changes since initial authorisation of medicine

Arepanrix : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Arepanrix : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Arepanrix

Adopted Reference Number: EMA/CHMP/30965/2010