Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals

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

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The marketing authorisation for Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals has been withdrawn at the request of the marketing-authorisation holder.

Name Language First published Last updated
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public BG = bălgarski 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public ES = español 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public CS = čeština 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public DA = dansk 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public DE = Deutsch 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public ET = eesti keel 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public EL = elliniká 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public EN = English 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public FR = français 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public IT = italiano 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public LV = latviešu valoda 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public LT = lietuvių kalba 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public HU = magyar 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public MT = Malti 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public NL = Nederlands 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public PL = polski 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public PT = português 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public RO = română 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public SK = slovenčina 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public SL = slovenščina 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public FI = suomi 2009-08-17 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Summary for the public SV = svenska 2009-08-17 2012-03-21

This EPAR was last updated on 21/03/2012 .

Authorisation details

Product details

Product details for Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
NamePrepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
Agency product numberEMEA/H/C/001015
Active substance

split influenza virus, inactivated, containing antigen: A/VietNam/1194/2004 (H5N1) like strain used (NIBRG-14)

International non-proprietary name (INN) or common name

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

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

Publication details

Publication details for Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals
Marketing-authorisation holder

GlaxoSmithKline Biologicals S.A.

Revision3
Date of issue of marketing authorisation valid throughout the European Union26/09/2008

Contact address:

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

Product information

Product information

03/10/2011  Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals -EMEA/H/C/001015 -II/0013

Name Language First published Last updated
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - Product Information SV = svenska 2009-12-07 2012-03-21

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
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21
Prepandemic Influenza Vaccine (H5N1) (Split Virion, Inactivated, Adjuvanted) GlaxoSmithKline Biologicals : EPAR - All Authorised presentations SV = svenska 2008-10-23 2012-03-21

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunisation against H5N1 subtype of Influenza A virus.

This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).

Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 µg should be used in accordance with official guidance.

Assessment History

Withdrawn

This medicine is now withdrawn from use in the European Union

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