Intanza

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (split virion, inactivated)

Overview

The marketing authorisation for Intanza has been withdrawn at the request of the marketing authorisation holder.

Intanza : EPAR - Summary for the public

Product information

Intanza : EPAR - Product Information

Latest procedure affecting product information: II/0054

07/09/2017

This medicine’s product information is available in all official EU languages.
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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).

Intanza : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Intanza
• 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 Intanza should be based on official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/000957
• Marketing authorisation holder:
  Sanofi Pasteur Europe

  2 Avenue Pont Pasteur; 69007 Lyon; France

• Marketing authorisation issued:
  24/02/2009
• Revision:
  18

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Intanza : EPAR - Public assessment report

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

Reference Number: EMEA/CHMP/642748/2008