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

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

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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.

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

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

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

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

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