Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals

Withdrawn

This medicine's authorisation has been withdrawn

prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)

Overview

On the 26 September 2008 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals, prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) A/VietNam/1194/2004 NIBRG-14, which had been approved as for prophylaxis of influenza in an officially declared pandemic situation. 

The marketing authorisation holder (MAH) responsible for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals was GlaxoSmithKline Biologicals S.A. The European Commission was notified by a letter dated 12 August 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals for commercial reasons. Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals was not marketed in any country of the European Union. 

On 3 October 2011 the European Commission issued a decision to withdraw the marketing authorisation for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals. 

Pursuant to this decision the European Public Assessment Report for Prepandemic influenza vaccine (H5N1) GlaxoSmithKline Biologicals is updated to reflect that the marketing authorisation is no longer valid.

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public

Product information

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
• Active substance:
  split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)
• International non-proprietary name (INN) or common name:
  prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against H5N1 subtype of Influenza A virus.

This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).

Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/001015
• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.

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

• Marketing authorisation issued:
  26/09/2008
• Withdrawal of marketing authorisation:
  03/11/2011
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Procedural steps taken and scientific information after authorisation

Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals-H-C-1051-II-01 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/352156/2009

CHMP post-authorisation summary of positive opinion for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Adopted Reference Number: EMEA/CHMP/332974/2009

Initial marketing authorisation documents

Committee for medicinal products for human use, summary of positive opinion for Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals

Reference Number: EMEA/CHMP/366446/2008