Intanza
influenza vaccine (split virion, inactivated)
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Intanza has been withdrawn at the request of the marketing authorisation holder.
This EPAR was last updated on 04/09/2018
Authorisation details
| Product details | |
|---|---|
| Name |
Intanza
|
| Agency product number |
EMEA/H/C/000957
|
| 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) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Sanofi Pasteur Europe
|
| Revision |
18
|
| Date of issue of marketing authorisation valid throughout the European Union |
24/02/2009
|
| Contact address |
2 Avenue Pont Pasteur
69007 Lyon France |
Product information
07/09/2017 Intanza - EMEA/H/C/000957 - II/0054
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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Pharmacotherapeutic group
Pharmacotherapeutic group
Vaccines
Therapeutic indication
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.