Prepandrix

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 17 December 2020, the European Commission withdrew the marketing authorisation for Prepandrix (prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, GlaxoSmithkline Biologicals SA, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Prepandrix was granted marketing authorisation in the EU on 14 May 2008 for active immunisation against H5N1 subtype of influenza A virus. The marketing authorisation was initially valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2013. It was then granted unlimited validity in 2017. The product had not been manufactured since 2010. 

The European Public Assessment Report (EPAR) for Prepandrix is updated to indicate that the marketing authorisation is no longer valid.

Prepandrix : EPAR - Summary for the public

Product information

Prepandrix : EPAR - Product Information

Prepandrix : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Prepandrix
• Active substance:
  A/Indonesia/05/2005 (H5N1) like strain used (PR8-IBCDC-RG2)
• 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 with H5N1 subtype strains.

Prepandrix should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000822
• Accelerated assessment:

  This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment.

• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.

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

• Marketing authorisation issued:
  14/05/2008
• Withdrawal of marketing authorisation:
  17/12/2020
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

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

Prepandrix-H-C-822-P46-0054 : EPAR - Assessment Report

Adopted Reference Number: EMA/121454/2015

Prepandrix-H-C-822-P46-0055 : EPAR - Assessment Report

Adopted Reference Number: EMA/544203/2014

Prepandrix-H-C-822-PSUV-0049 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/252828/2014

Prepandrix-H-C-822-II-0029 : EPAR - Assessment Report - Variation

Adopted

Prepandrix-H-C-822-II-0026 : EPAR - Assessment Report - Variation

Adopted

Prepandrix-H-C-822-II-0005 : EPAR - Assessment Report - Variation

Reference Number: EMEA/CHMP/352133/2009

CHMP post-authorisation summary of positive opinion for Prepandrix

Adopted Reference Number: EMEA/CHMP/62736/2008

Initial marketing authorisation documents

CHMP summary of positive opinion for Prepandrix

Reference Number: EMEA/CHMP/334055/2009

Prepandrix : EPAR - Public assessment report