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

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

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

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.

This EPAR was last updated on 07/03/2016

Authorisation details

Product details
Name
Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
Agency product number
EMEA/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 (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02
Publication details
Marketing-authorisation holder
Novartis Vaccines and Diagnostics S.r.l.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
29/11/2010
Contact address
Via Fiorentina, 1
IT-53100 Siena
Italy

Product information

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

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.

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

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