Pandemrix

influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) A/California/7/2009 (H1N1)v like strain (x-179a)

  • Email
  • Help

About

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

Name Language First published Last updated
Pandemrix : EPAR - Summary for the public BG = bălgarski 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public ES = español 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public CS = čeština 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public DA = dansk 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public DE = Deutsch 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public ET = eesti keel 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public EL = elliniká 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public EN = English 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public FR = français 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public IT = italiano 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public LV = latviešu valoda 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public LT = lietuvių kalba 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public HU = magyar 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public MT = Malti 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public NL = Nederlands 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public PL = polski 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public PT = português 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public RO = română 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public SK = slovenčina 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public SL = slovenščina 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public FI = suomi 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public SV = svenska 2009-12-22 2016-06-10
Pandemrix : EPAR - Summary for the public HR = Hrvatski 2009-12-22 2016-06-10

This EPAR was last updated on 10/06/2016 .

Authorisation details

Product details

Product details for Pandemrix
NamePandemrix
Agency product numberEMEA/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) A/California/7/2009 (H1N1)v like strain (x-179a)

Therapeutic area Influenza, HumanImmunizationDisease Outbreaks
Anatomical therapeutic chemical (ATC) code J07BB02

Publication details

Publication details for Pandemrix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision23
Date of issue of marketing authorisation valid throughout the European Union20/05/2008

Contact address:

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

Product information

Product information

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

Name Language First published Last updated
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10
Pandemrix : EPAR - Product Information HR = Hrvatski 2009-12-23 2016-06-10

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 2009-10-01 2015-10-27

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

Name Language First published Last updated
Pandemrix : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-12-04 2016-06-10
Pandemrix-H-C-832-II-0079 : EPAR - Assessment Report - Variation HR = Hrvatski 2016-06-10  
Pandemrix-H-C-832-A20-0045 : EPAR - Assessment Report - Article 20 HR = Hrvatski 2011-11-25 2015-10-27
Pandemrix-H-C-832-II-0025 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-04 2015-10-27
Pandemrix-H-C-832-II-0019 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-11-16 2015-10-27
Pandemrix-H-C-832-II-0061 : EPAR - Assessment Report - Variation HR = Hrvatski 2013-12-09 2015-10-27
Pandemrix-H-C-832-II-0026 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-04 2015-10-27
Pandemrix-H-C-832-II-0024 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-04 2015-10-27
Pandemrix-H-C-832-II-0023 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-04 2015-10-27
Pandemrix-H-C-832-P46-0099 : EPAR - Assessment Report HR = Hrvatski 2015-03-17 2015-10-27
Pandemrix-H-C-832-II-0052 : EPAR - Assessment Report - Variation HR = Hrvatski 2011-11-25 2015-10-27
Pandemrix-H-C-832-PU-0017 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-10-02 2015-10-27
Pandemrix-H-C-832-II-0051 : EPAR - Assessment Report - Variation HR = Hrvatski 2011-11-25 2015-10-27
Pandemrix-H-C-832-II-0005 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-08-14 2015-10-27
Pandemrix-H-C-832-II-0046 : EPAR - Assessment Report - Variation HR = Hrvatski 2011-07-25 2015-10-27
Pandemrix-H-C-832-SW-0041 : EPAR - Assessment Report - Variation HR = Hrvatski 2010-10-04 2015-10-27
Pandemrix-H-C-832-II-0048: EPAR - Assessment Report - Variation HR = Hrvatski 2011-07-25 2015-10-27
Pandemrix-H-C-832-II-0028 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-23 2015-10-27
Pandemrix-H-C-832-II-0032 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-23 2015-10-27
Pandemrix-H-C-832-II-0034 : EPAR - Assessment Report - Variation HR = Hrvatski 2009-12-23 2015-10-27
Pandemrix-H-C-832-II-0033 : EPAR - Assessment Report - Variation HR = Hrvatski 2010-03-04 2015-10-27
Pandemrix-H-C-832-II-0069 : EPAR - Assessment Report - Variation HR = Hrvatski 2014-10-08 2015-10-27
Pandemrix-H-C-832-P46-0102-0103 : EPAR - Assessment Report HR = Hrvatski 2015-03-17 2015-10-27

Initial marketing-authorisation documents

Name Language First published Last updated
Pandemrix : EPAR - Public assessment report HR = Hrvatski 2008-06-03 2015-10-27
Committee for medicinal products for human use, summary of positive opinion for Pandemrix HR = Hrvatski 2008-02-21 2015-10-27

Withdrawn

This medicine is now withdrawn from use in the European Union

News

More information on Pandemrix