Pumarix

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Pumarix has been withdrawn at the request of the marketing authorisation holder.

Pumarix : EPAR - Summary for the public

Product information

Pumarix : EPAR - Product Information

Latest procedure affecting product information: P46/0016

28/02/2014

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).

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.

  GlaxoSmithKline Biologicals S.A.; 89, rue de l'Institut; B-1330 Rixensart; Belgium

• Marketing authorisation issued:
  04/03/2011
• 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