Fluenz
Withdrawn
This medicine's authorisation has been withdrawn
influenza vaccine (live attenuated, nasal)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1st October 2014, the European Commission withdrew the marketing authorisation for Fluenz (influenza vaccine (live attenuated, nasal)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, MedImmune LLC, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Fluenz was granted marketing authorisation in the EU on 27 January 2011 for the prevention of influenza (flu). The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since the 2013-14 influenza season.
Fluenz is a trivalent (containing three strains of flu virus) influenza vaccine. It will be replaced by Fluenz Tetra, a tetravalent (four-strain) influenza vaccine which is authorised in the EU since 04 December 2013 for the same indication as Fluenz, i.e. prevention of influenza. MedImmune LLC will maintain the marketing authorisation for Fluenz Tetra.
The European Public Assessment Report (EPAR) for Fluenz is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IAIN/0056
21/10/2013
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).
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
VaccinesTherapeutic 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.
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