Pumarix

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

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The marketing authorisation for Pumarix has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Pumarix : EPAR - Summary for the public BG = bălgarski 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public ES = español 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public CS = čeština 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public DA = dansk 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public DE = Deutsch 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public ET = eesti keel 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public EL = elliniká 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public EN = English 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public FR = français 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public IT = italiano 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public LV = latviešu valoda 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public LT = lietuvių kalba 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public HU = magyar 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public MT = Malti 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public NL = Nederlands 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public PL = polski 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public PT = português 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public RO = română 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public SK = slovenčina 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public SL = slovenščina 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public FI = suomi 05/04/2011 17/03/2015
Pumarix : EPAR - Summary for the public SV = svenska 05/04/2011 17/03/2015

This EPAR was last updated on 17/03/2015 .

Authorisation details

Product details

Product details for Pumarix
NamePumarix
Agency product numberEMEA/H/C/001212
Active substance

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

International non-proprietary name (INN) or common name

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

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

There were "exceptional circumstances" concerning the approval of this medicine. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicine for which authorisation is being sought, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data.

Publication details

Publication details for Pumarix
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.
 

Revision4
Date of issue of marketing authorisation valid throughout the European Union04/03/2011

Contact address:

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

Product information

Product information

28/02/2014  Pumarix -EMEA/H/C/001212 -P46/0016

Name Language First published Last updated
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - Product Information SV = svenska 05/04/2011 17/03/2015

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
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015
Pumarix : EPAR - All Authorised presentations SV = svenska 05/04/2011 17/03/2015

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation.

Pandemic-influenza vaccine should be used in accordance with official guidance.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Pumarix : EPAR - Public assessment report SV = svenska 05/04/2011 17/03/2015
CHMP summary of positive opinion for Pumarix SV = svenska 19/11/2010 17/03/2015

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Pumarix