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

Expired

This medicine's authorisation has expired

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

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.

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Summary for the public

Reference Number: EMA/CHMP/670965/2010

Product information

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Product Information

Latest procedure affecting product information: PSUSA/10008

28/07/2015

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/002269
• Marketing authorisation holder:
  Novartis Vaccines and Diagnostics S.r.l.

  Via Fiorentina, 1; IT-53100 Siena; Italy

• Marketing authorisation issued:
  29/11/2010
• Expiry of marketing authorisation:
  28/11/2015
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Procedural steps taken and scientific information after authorisation

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics-H-C-PSUSA-00010008/201410 : EPAR - Scientific conclusions and grounds recommending the variation to the te...

Initial marketing authorisation documents

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics : EPAR - Public assessment report

CHMP summary of positive opinion for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostics

AdoptedReference Number: EMA/CHMP/597536/2010