Prepandrix

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Prepandrix has been withdrawn at the request of the marketing-authorisation holder. 

Prepandrix : EPAR - Summary for the public

Product information

Prepandrix : EPAR - Product Information

Latest procedure affecting product information: IB/0077

20/09/2018

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).

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
• 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

AdoptedReference Number: EMA/121454/2015

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

AdoptedReference 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

AdoptedReference 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