Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics

prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

  • Email
  • Help

About

The marketing authorisation for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics has expired following the marketing-authorisation holder's decision not to apply for a renewal.

Name Language First published Last updated
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public BG = bălgarski 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public ES = español 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public CS = čeština 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public DA = dansk 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public DE = Deutsch 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public ET = eesti keel 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public EL = elliniká 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public EN = English 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public FR = français 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public IT = italiano 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public LV = latviešu valoda 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public LT = lietuvių kalba 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public HU = magyar 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public MT = Malti 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public NL = Nederlands 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public PL = polski 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public PT = português 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public RO = română 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public SK = slovenčina 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public SL = slovenščina 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public FI = suomi 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public SV = svenska 24/01/2011  

This EPAR was last updated on 07/03/2016 .

Authorisation details

Product details

Product details for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
NamePrepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Agency product numberEMEA/H/C/002269
Active substance

influenza virus surface antigens (haemagglutinin and neuraminidase) of strain A/Viet Nam/1194/2004 (H5N1)

International non-proprietary name (INN) or common name

prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted)

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

Publication details

Publication details for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Marketing-authorisation holder

Novartis Vaccines and Diagnostics S.r.l.

Revision2
Date of issue of marketing authorisation valid throughout the European Union29/11/2010

Contact address:

Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1
IT-53100 Siena
Italy

Product information

Product information

28/07/2015  Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics -EMEA/H/C/002269 -PSUSA/10008

Name Language First published Last updated
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information SV = svenska 24/01/2011 11/09/2015

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
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations SV = svenska 24/01/2011  

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 the vaccine containing A/Vietnam/1194/2004 (H5N1)-like strain.

Prepandemic influenza vaccine (H5N1) Novartis Vaccines and Diagnostic  should be used in accordance with official recommendations.

Assessment History

Withdrawn

This medicine is now withdrawn from use in the European Union

Related information