Focetria

Expired

This medicine's authorisation has expired

influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)

Overview

The marketing authorisation for Focetria (influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)) expired on 13 August 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. 

Novartis Vaccines and Diagnostics S.r.l. confirmed that it did not apply for renewal of the authorisation due to lack of demand for this product. 

Focetria was granted marketing authorisation in the European Union (EU) on 12 August 2010 for prophylaxis of influenza caused by A/H1N1v 2009 virus. The marketing authorisation was valid for a 5- year period. 

Novartis Vaccines and Diagnostics S.r.l. (now named Seqirus) is the marketing authorisation holder for another pandemic vaccine, Foclivia, which is authorised in the EU for pandemic preparedness. Seqirus will maintain the marketing authorisation for Foclivia. 

The European Public Assessment Report (EPAR) for Focetria is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Focetria : EPAR - Summary for the public

Product information

Focetria : EPAR - Product Information

Focetria : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Focetria
• Active substance:
  Influenza virus surface antigens (haemagglutinin and neuraminidase) of strain: A/California/7/2009 (H1N1)-derived strain used NYMC X-181
• International non-proprietary name (INN) or common name:
  influenza vaccine H1N1v (surface antigen, inactivated, adjuvanted)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Influenza vaccines

Therapeutic indication

Prophylaxis of influenza caused by A (H1N1v) 2009 virus.

Focetria should be used in accordance with official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000710
• Marketing authorisation holder:
  Novartis Vaccines and Diagnostics S.r.l.

  Via Fiorentina, 1; IT-53100 Siena; Italy

• Marketing authorisation issued:
  02/05/2007
• Expiry of marketing authorisation:
  13/08/2015
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Focetria : EPAR - Procedural steps taken and scientific information after authorisation

Focetria-H-C-710-PSUV-0033 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/26367/2015

Focetria-H-C-710-SW-0024 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/326579/2010

Focetria-H-C-710-II-0020 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/172703/2010

Focetria-H-C-710-II-0018 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMA/CHMP/842825/2009

Focetria-H-C-710-II-0015 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/759929/2009

Focetria-H-C-710-II-0013 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/759928/2009

Focetria-H-C-710-II-0011 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/704703/2009

Focetria-H-C-710-II-0010 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/704698/2009

Focetria-H-C-710-II-0009 : EPAR - Assessment Report - Variation

Adopted Reference Number: EMEA/CHMP/704696/2009

Initial marketing authorisation documents

Focetria : EPAR - Assessment Report

Focetria : EPAR - Procedural steps taken before authorisation

Focetria : EPAR - Scientific Discussion