Optaflu

Expired

This medicine's authorisation has expired

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Overview

The marketing authorisation for Optaflu [influenza vaccine (surface antigen, inactivated, prepared in cell cultures)] expired on 5 June 2017 following the decision of the marketing authorisation holder, Seqirus GmbH, not to apply for a renewal of the marketing authorisation. Seqirus GmbH confirmed that it did not apply for renewal of the authorisation due to commercial reasons. 

Optaflu was granted marketing authorisation in the European Union (EU) on 1 June 2007 for prophylaxis of influenza for adults. The marketing authorisation was valid for a 5-year period. It was subsequently renewed for an additional 5-year period in 2012. 

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Assessment Report (EPAR) for Optaflu is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Optaflu : EPAR - Summary for the public

Product information

Optaflu : EPAR - Product Information

Optaflu : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Optaflu
• Active substance:
  influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type)
• International non-proprietary name (INN) or common name:
  influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza for adults, especially in those who run an increased risk of associated complications.

Optaflu should be used in accordance to official guidance.

Authorisation details

• EMA product number:
  EMEA/H/C/000758
• Marketing authorisation holder:
  Seqirus GmbH

  Emil-von-Behring Strasse 76; 35041 Marburg; Germany

• Marketing authorisation issued:
  01/06/2007
• Expiry of marketing authorisation:
  05/06/2017
• Revision:
  16

Assessment history

Changes since initial authorisation of medicine

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

Optaflu-H-C-PSUSA-00001745-201504 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/146531/2016

Optaflu-H-C-758-P46-0052 : EPAR - Assessment Report

AdoptedReference Number: EMA/CHMP/538134/2015

Optaflu-H-C-758-P-46-0053 : EPAR - Assessment Report

AdoptedReference Number: EMA/250256/2015

Optaflu-H-C-758-PSUV-0070 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/26383/2015

Initial marketing authorisation documents

Optaflu : EPAR - Procedural steps taken before authorisation

Optaflu : EPAR - Scientific Discussion