Fluenz
influenza vaccine (live attenuated, nasal)
Table of contents
Overview
The marketing authorisation for Fluenz has been withdrawn at the request of the marketing authorisation holder.
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) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB03
|
Additional 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.