Pandemrix

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

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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 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public ES = español 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public CS = čeština 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public DA = dansk 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public DE = Deutsch 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public ET = eesti keel 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public EL = elliniká 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public EN = English 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public FR = français 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public IT = italiano 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public LV = latviešu valoda 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public LT = lietuvių kalba 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public HU = magyar 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public MT = Malti 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public NL = Nederlands 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public PL = polski 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public PT = português 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public RO = română 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public SK = slovenčina 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public SL = slovenščina 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public FI = suomi 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public SV = svenska 22/12/2009 27/10/2015
Pandemrix : EPAR - Summary for the public HR = Hrvatski 22/12/2009 27/10/2015

This EPAR was last updated on 27/10/2015 .

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.

Revision22
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

13/08/2015  Pandemrix -EMEA/H/C/000832 -II/0078

Name Language First published Last updated
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix : EPAR - Product Information HR = Hrvatski 23/12/2009 27/10/2015

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 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015
Pandemrix : EPAR - All Authorised presentations HR = Hrvatski 01/10/2009 27/10/2015

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 04/12/2009 27/10/2015
Pandemrix-H-C-832-II-0025 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009 27/10/2015
Pandemrix-H-C-832-II-0033 : EPAR - Assessment Report - Variation HR = Hrvatski 04/03/2010 27/10/2015
Pandemrix-H-C-832-II-0019 : EPAR - Assessment Report - Variation HR = Hrvatski 16/11/2009 27/10/2015
Pandemrix-H-C-832-II-0061 : EPAR - Assessment Report - Variation HR = Hrvatski 09/12/2013 27/10/2015
Pandemrix-H-C-832-A20-0045 : EPAR - Assessment Report - Article 20 HR = Hrvatski 25/11/2011 27/10/2015
Pandemrix-H-C-832-II-0024 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009 27/10/2015
Pandemrix-H-C-832-II-0026 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009 27/10/2015
Pandemrix-H-C-832-II-0023 : EPAR - Assessment Report - Variation HR = Hrvatski 04/12/2009 27/10/2015
Pandemrix-H-C-832-II-0052 : EPAR - Assessment Report - Variation HR = Hrvatski 25/11/2011 27/10/2015
Pandemrix-H-C-832-II-0051 : EPAR - Assessment Report - Variation HR = Hrvatski 25/11/2011 27/10/2015
Pandemrix-H-C-832-II-0005 : EPAR - Assessment Report - Variation HR = Hrvatski 14/08/2009 27/10/2015
Pandemrix-H-C-832-PU-0017 : EPAR - Assessment Report - Variation HR = Hrvatski 02/10/2009 27/10/2015
Pandemrix-H-C-832-P46-0099 : EPAR - Assessment Report HR = Hrvatski 17/03/2015 27/10/2015
Pandemrix-H-C-832-II-0048: EPAR - Assessment Report - Variation HR = Hrvatski 25/07/2011 27/10/2015
Pandemrix-H-C-832-SW-0041 : EPAR - Assessment Report - Variation HR = Hrvatski 04/10/2010 27/10/2015
Pandemrix-H-C-832-II-0046 : EPAR - Assessment Report - Variation HR = Hrvatski 25/07/2011 27/10/2015
Pandemrix-H-C-832-II-0032 : EPAR - Assessment Report - Variation HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix-H-C-832-II-0028 : EPAR - Assessment Report - Variation HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix-H-C-832-II-0034 : EPAR - Assessment Report - Variation HR = Hrvatski 23/12/2009 27/10/2015
Pandemrix-H-C-832-II-0069 : EPAR - Assessment Report - Variation HR = Hrvatski 08/10/2014 27/10/2015
Pandemrix-H-C-832-P46-0102-0103 : EPAR - Assessment Report HR = Hrvatski 17/03/2015 27/10/2015

Initial marketing-authorisation documents

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

Withdrawn

This medicine is now withdrawn from use in the European Union

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