Pandemrix

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

Overview
Authorisation details
Product information
Assessment history

Withdrawn

This medicine is now withdrawn from use in the European Union.

Overview

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

List item

Pandemrix : EPAR - Summary for the public (PDF/122.93 KB)

First published: 22/12/2009
Last updated: 10/06/2016
EMA/684025/2012
- Bulgarian
  (PDF/167.25 KB)
- Croatian
  (PDF/130.83 KB)
- Czech
  (PDF/143.01 KB)
- Danish
  (PDF/133.72 KB)
- Dutch
  (PDF/131.32 KB)
- Estonian
  (PDF/120.64 KB)
- Finnish
  (PDF/122.5 KB)
- French
  (PDF/148.75 KB)
- German
  (PDF/125.39 KB)
- Greek
  (PDF/173.86 KB)
- Hungarian
  (PDF/167.66 KB)
- Italian
  (PDF/121.53 KB)
- Latvian
  (PDF/143.99 KB)
- Lithuanian
  (PDF/176.22 KB)
- Maltese
  (PDF/160.07 KB)
- Polish
  (PDF/166.63 KB)
- Portuguese
  (PDF/127.26 KB)
- Romanian
  (PDF/151.59 KB)
- Slovak
  (PDF/153.08 KB)
- Slovenian
  (PDF/143.17 KB)
- Spanish
  (PDF/126.22 KB)
- Swedish
  (PDF/136.25 KB)

This EPAR was last updated on 10/06/2016

Authorisation details

Product details
Name	Pandemrix
Agency product number	EMEA/H/C/000832
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

Publication details
Marketing-authorisation holder	GlaxoSmithKline Biologicals S.A.
Revision	23
Date of issue of marketing authorisation valid throughout the European Union	20/05/2008
Contact address	Rue de l'Institut, 89 B-1330 Rixensart Belgium

Product information

28/04/2016 Pandemrix - EMEA/H/C/000832 - II/0079

List item

Pandemrix : EPAR - Product Information (PDF/1.11 MB)

First published: 23/12/2009
Last updated: 10/06/2016
- Bulgarian
  (PDF/1.58 MB)
- Croatian
  (PDF/949.96 KB)
- Czech
  (PDF/1.21 MB)
- Danish
  (PDF/1.36 MB)
- Dutch
  (PDF/1.2 MB)
- Estonian
  (PDF/1.07 MB)
- Finnish
  (PDF/1.19 MB)
- French
  (PDF/1.09 MB)
- German
  (PDF/1.2 MB)
- Greek
  (PDF/1.66 MB)
- Hungarian
  (PDF/1.77 MB)
- Icelandic
  (PDF/1.19 MB)
- Italian
  (PDF/1003.34 KB)
- Latvian
  (PDF/1.08 MB)
- Lithuanian
  (PDF/1.23 MB)
- Maltese
  (PDF/1.37 MB)
- Norwegian
  (PDF/1.21 MB)
- Polish
  (PDF/1.67 MB)
- Portuguese
  (PDF/1.01 MB)
- Romanian
  (PDF/1.3 MB)
- Slovak
  (PDF/1.27 MB)
- Slovenian
  (PDF/1.19 MB)
- Spanish
  (PDF/1.2 MB)
- Swedish
  (PDF/1.47 MB)

Other EU languages available icon 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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

List item

Pandemrix : EPAR - All Authorised presentations (PDF/472.78 KB)

First published: 01/10/2009
Last updated: 27/10/2015
- Bulgarian
  (PDF/589.98 KB)
- Czech
  (PDF/578.21 KB)
- Danish
  (PDF/516.06 KB)
- Dutch
  (PDF/472.76 KB)
- Estonian
  (PDF/473.26 KB)
- Finnish
  (PDF/464.32 KB)
- French
  (PDF/514.55 KB)
- German
  (PDF/472.76 KB)
- Greek
  (PDF/593.22 KB)
- Hungarian
  (PDF/582.28 KB)
- Italian
  (PDF/513.09 KB)
- Latvian
  (PDF/578.43 KB)
- Lithuanian
  (PDF/556.74 KB)
- Maltese
  (PDF/580.98 KB)
- Polish
  (PDF/572.59 KB)
- Portuguese
  (PDF/518.31 KB)
- Romanian
  (PDF/562.05 KB)
- Slovak
  (PDF/576.85 KB)
- Slovenian
  (PDF/485.18 KB)
- Spanish
  (PDF/515.28 KB)
- Swedish
  (PDF/476.27 KB)

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.

Assessment history

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

List item

Pandemrix : EPAR - Public assessment report (PDF/1.04 MB)

First published: 03/06/2008
Last updated: 27/10/2015

Pandemrix

Table of contents

Overview

Pandemrix : EPAR - Summary for the public (PDF/122.93 KB)

Authorisation details

Product information

Pandemrix : EPAR - Product Information (PDF/1.11 MB)

Pandemrix : EPAR - All Authorised presentations (PDF/472.78 KB)

Pharmacotherapeutic group

Therapeutic indication

Assessment history

Changes since initial authorisation of medicine

Pandemrix : EPAR - Procedural steps taken and scientific information after authorisation (PDF/210.28 KB)

Pandemrix-H-C-832-II-0079 : EPAR - Assessment Report - Variation (PDF/3.42 MB)

Pandemrix-H-C-832-P46-0099 : EPAR - Assessment Report (PDF/672.8 KB)

Pandemrix-H-C-832-P46-0102-0103 : EPAR - Assessment Report (PDF/2.49 MB)

Pandemrix-H-C-832-II-0069 : EPAR - Assessment Report - Variation (PDF/1.22 MB)

Pandemrix-H-C-832-II-0061 : EPAR - Assessment Report - Variation (PDF/1.5 MB)

Pandemrix-H-C-832-II-0051 : EPAR - Assessment Report - Variation (PDF/910.71 KB)

Pandemrix-H-C-832-A20-0045 : EPAR - Assessment Report - Article 20 (PDF/837.01 KB)

Pandemrix-H-C-832-II-0052 : EPAR - Assessment Report - Variation (PDF/907.88 KB)

Pandemrix-H-C-832-II-0048: EPAR - Assessment Report - Variation (PDF/990.93 KB)

Pandemrix-H-C-832-II-0046 : EPAR - Assessment Report - Variation (PDF/1.02 MB)

Pandemrix-H-C-832-SW-0041 : EPAR - Assessment Report - Variation (PDF/937.3 KB)

Pandemrix-H-C-832-II-0033 : EPAR - Assessment Report - Variation (PDF/1.54 MB)

Pandemrix-H-C-832-II-0034 : EPAR - Assessment Report - Variation (PDF/773.43 KB)

Pandemrix-H-C-832-II-0032 : EPAR - Assessment Report - Variation (PDF/765.38 KB)

Pandemrix-H-C-832-II-0028 : EPAR - Assessment Report - Variation (PDF/850.31 KB)

Pandemrix-H-C-832-II-0026 : EPAR - Assessment Report - Variation (PDF/518.55 KB)

Pandemrix-H-C-832-II-0023 : EPAR - Assessment Report - Variation (PDF/640.06 KB)

Pandemrix-H-C-832-II-0024 : EPAR - Assessment Report - Variation (PDF/575.62 KB)

Pandemrix-H-C-832-II-0025 : EPAR - Assessment Report - Variation (PDF/1.61 MB)

Pandemrix-H-C-832-II-0019 : EPAR - Assessment Report - Variation (PDF/676.51 KB)

Pandemrix-H-C-832-PU-0017 : EPAR - Assessment Report - Variation (PDF/1.76 MB)

Pandemrix-H-C-832-II-0005 : EPAR - Assessment Report - Variation (PDF/909.87 KB)

Initial marketing-authorisation documents

Pandemrix : EPAR - Public assessment report (PDF/1.04 MB)

News

More information on Pandemrix

Public statement on Pandemrix: Expiry of the marketing authorisation in the European Union (PDF/67.01 KB)

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