Fluenz

Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (live attenuated, nasal)

Overview

The marketing authorisation for Fluenz has been withdrawn at the request of the marketing authorisation holder.

Fluenz : EPAR - Summary for the public

Reference Number: EMA/CHMP/682933/2010

Product information

Fluenz : EPAR - Product Information

Latest procedure affecting product information: IAIN/0056

21/10/2013

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).

Fluenz : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Fluenz
• Active substance:
  Reassortant influenza virus (live attenuated) of the following strains:A/California/7/2009 (H1N1)pdm09 like strain, A/Victoria/361/2011 (H3N2) like strain, B/Massachusetts/2/2012 like strain
• International non-proprietary name (INN) or common name:
  influenza vaccine (live attenuated, nasal)
• Therapeutic area (MeSH):
  • Influenza, Human
  • Immunization
• Anatomical therapeutic chemical (ATC) code:
  J07BB03

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in individuals 24 months to less than 18 years of age.

The use of Fluenz should be based on official recommendations.

Authorisation details

• EMA product number:
  EMEA/H/C/001101
• Marketing authorisation holder:
  MedImmune LLC

  Lagelandseweg 78; NL-6545 CG Nijmegen; The Netherlands

• Marketing authorisation issued:
  27/01/2011
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

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

Fluenz-H-C-1101-P46-27 : EPAR - Assessment Report

AdoptedReference Number: EMA/649861/2014

Fluenz-H-C-1101-P46-28.1 : EPAR - Assessment Report

AdoptedReference Number: EMA/649874/2014

Initial marketing authorisation documents

Fluenz : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Fluenz

AdoptedReference Number: EMA/CHMP/503333/2010