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 Diagnostic expired on 28 November 2015 following the decision of the marketing authorisation holder, Novartis Vaccines and Diagnostics S.r.l., not to apply for a renewal of the marketing authorisation. 

The vaccine contained haemagglutinin and neuraminidase of influenza virus H5N1 A/Vietnam/1194/2004. Novartis Vaccines and Diagnostics S.r.l. (now named Seqirus) confirmed that it did not apply for renewal of the authorisation due to lack of demand for this product. 

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic was granted marketing authorisation in the European Union (EU) on 29 November 2010 for immunisation against the H5N1 subtype of influenza A virus. The marketing authorisation was valid for a 5-year period. 

Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic was a duplicate application to Aflunov, which is authorised in the EU. The marketing authorisation holder (Seqirus) will maintain the marketing authorisation for Aflunov. 

The European Public Assessment Report (EPAR) for Prepandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted) Novartis Vaccines and Diagnostic is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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

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

Adopted Reference Number: EMA/CHMP/597536/2010