IDflu

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (split virion, inactivated)

Overview

On 19 March 2018, the European Commission withdrew the marketing authorisation for IDflu (influenza vaccine (split virion, inactivated)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Pasteur SA, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

IDflu was granted marketing authorisation in the EU on 24 February 2009 for prophylaxis of influenza in individuals 18 years of age and over. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014. The product had not been marketed in the EU since 2015. IDflu was a duplicate application to Intanza, which is authorised in the EU to prevent influenza in individuals 60 years of age and over, especially in those who are at increased risk of associated complications. 

IDflu is an identical product to Vaxigrip and is similar to VaxigripTetra, which are marketed in several EU countries. The marketing authorisation holder will maintain the marketing authorisation for these vaccines. 

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Assessment Report (EPAR) for IDflu is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

IDflu : EPAR - Summary for the public

Product information

IDflu : EPAR - Product Information

IDflu : EPAR - All Authorised presentations

Product details

• Name of medicine:
  IDflu
• Active substance:
  influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
• International non-proprietary name (INN) or common name:
  influenza vaccine (split virion, inactivated)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
• Anatomical therapeutic chemical (ATC) code:
  J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in individuals 60 years of age and over, especially in those who run an increased risk of associated complications.
The use of IDflu should be based on official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/000966
• Marketing authorisation holder:
  Sanofi Pasteur S.A.

  2, avenue Pont Pasteur; F-69007 Lyon; France

• Marketing authorisation issued:
  24/02/2009
• Withdrawal of marketing authorisation:
  19/03/2018
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

IDflu : EPAR - Public assessment report

Committee for medicinal products for human use, summary of positive opinion for IDflu

Reference Number: EMEA/CHMP/642949/2008