Pumarix

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 11 February 2015, the European Commission withdrew the marketing authorisation for Pumarix (pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)) in the European Union (EU). The withdrawal was requested by the marketing authorisation holder, GlaxoSmithKline Biologicals, which notified the European Commission that it did not intend to maintain the marketing authorisation for commercial reasons. 

Pumarix was granted a marketing authorisation in the EU on 4 March 2011 for prevention of influenza (flu) in an officially declared pandemic situation. The marketing authorisation was valid for a 5-year period, subject to subsequent renewals. Pumarix has never been marketed in the EU, and was intended to be used in an officially declared influenza pandemic following the identification and, if appropriate, the inclusion of the influenza strain causing the pandemic into the vaccine. Another product, Adjupanrix (pandemic influenza vaccine A/H5N1, split virion, inactivated, adjuvanted) is authorised in the EU for prevention of influenza in an officially declared pandemic situation, and can be used instead of Pumarix. The marketing authorisation holder, GlaxoSmithKline Biologicals, will maintain the marketing authorisation for Adjupanrix. 

The European Public Assessment Report (EPAR) for Pumarix is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Pumarix : EPAR - Summary for the public

Product information

Pumarix : EPAR - Product Information

Pumarix : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pumarix
• Active substance:
  pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
• International non-proprietary name (INN) or common name:
  pandemic 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

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/001212
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.

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

• Marketing authorisation issued:
  04/03/2011
• Withdrawal of marketing authorisation:
  11/02/2015
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

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

Pumarix-H-C-1212-P46-0016 : EPAR - Assessment Report

AdoptedReference Number: EMA/711988/2014

Pumarix-H-C-1212-PSUV-0009 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/265942/2014

Initial marketing authorisation documents

Pumarix : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Pumarix

AdoptedReference Number: EMA/CHMP/692469/2010