Pandemrix

Expired

This medicine's authorisation has expired

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)

Overview

The marketing authorisation for Pandemrix has expired following the marketing-authorisation holder’s decision not to apply for a renewal.

Pandemrix : EPAR - Summary for the public

Reference Number: EMA/684025/2012

Product information

Pandemrix : EPAR - Product Information

Latest procedure affecting product information: II/0079

28/04/2016

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).

Pandemrix : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Pandemrix
• Active substance:
  split influenza virus inactivated, containing antigen equivalent to A/California/07/2009 (H1N1)-derived strain used NYMC X-179A
• International non-proprietary name (INN) or common name:
  influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the recommended annual seasonal trivalent / quadrivalent influenza vaccines are not available and if immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).

Pandemrix should be used in accordance with Official Guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000832
• Marketing authorisation holder:
  GlaxoSmithKline Biologicals S.A.

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

• Marketing authorisation issued:
  20/05/2008
• Expiry of marketing authorisation:
  13/08/2015
• Revision:
  23

Assessment history

Changes since initial authorisation of medicine

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

Pandemrix-H-C-832-II-0079 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/566359/2015

Pandemrix-H-C-832-P46-0102-0103 : EPAR - Assessment Report

AdoptedReference Number: EMA/180287/2015

Pandemrix-H-C-832-P46-0099 : EPAR - Assessment Report

AdoptedReference Number: EMA/180225/2015

Pandemrix-H-C-832-II-0069 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/521070/2014

Pandemrix-H-C-832-II-0061 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/691037/2013

Pandemrix-H-C-832-A20-0045 : EPAR - Assessment Report - Article 20

AdoptedReference Number: EMA/873244/2011

Pandemrix-H-C-832-II-0052 : EPAR - Assessment Report - Variation

Adopted

Pandemrix-H-C-832-II-0051 : EPAR - Assessment Report - Variation

Adopted

Pandemrix-H-C-832-II-0048: EPAR - Assessment Report - Variation

Adopted

Pandemrix-H-C-832-II-0046 : EPAR - Assessment Report - Variation

Adopted

Pandemrix-H-C-832-SW-0041 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/508065/2010

Pandemrix-H-C-832-II-0033 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/95394/2010

Pandemrix-H-C-832-II-0034 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/842790/2009

Pandemrix-H-C-832-II-0028 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/815870/2009

Pandemrix-H-C-832-II-0032 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMA/CHMP/842769/2009

Pandemrix-H-C-832-II-0023 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/763804/2009

Pandemrix-H-C-832-II-0024 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/763919/2009

Pandemrix-H-C-832-II-0025 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/763933/2009

Pandemrix-H-C-832-II-0026 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/763956/2009

Pandemrix-H-C-832-II-0019 : EPAR - Assessment Report - Variation

AdoptedReference Number: EMEA/CHMP/667130/2009

Pandemrix-H-C-832-PU-0017 : EPAR - Assessment Report - Variation

Reference Number: EMEA/CHMP/619109/2009

Pandemrix-H-C-832-II-0005 : EPAR - Assessment Report - Variation

Reference Number: EMEA/CHMP/352183/2009

Initial marketing authorisation documents

Pandemrix : EPAR - Public assessment report