Fluenz

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influenza vaccine (live attenuated, nasal)

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Fluenz has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 03/12/2014

Authorisation details

Product details
Name
Fluenz
Agency product number
EMEA/H/C/001101
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
MedImmune LLC
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
27/01/2011
Contact address
Lagelandseweg 78
NL-6545 CG Nijmegen
The Netherlands

Product information

21/10/2013 Fluenz - EMEA/H/C/001101 - IAIN/0056

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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