Arepanrix

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Arepanrix has been withdrawn at the request of the marketing authorisation holder.

Arepanrix : EPAR - Summary for the public

Product information

Arepanrix : EPAR - Product Information

Latest procedure affecting product information: IB/0005/G

13/08/2010

This medicine’s product information is available in all official EU languages.
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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).

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.

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

• Marketing authorisation issued:
  23/03/2010
• 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

AdoptedReference Number: EMA/CHMP/30965/2010