Optaflu
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Table of contents
Withdrawn
This medicine is now withdrawn from use in the European Union.
Overview
The marketing authorisation for Optaflu has expired following the marketing authorisation holder's decision not to apply for a renewal.
This EPAR was last updated on 27/06/2017
Authorisation details
| Product details | |
|---|---|
| Name |
Optaflu
|
| Agency product number |
EMEA/H/C/000758
|
| Active substance |
influenza virus surface antigens (haemagglutinin and neuraminidase), inactivated, of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain(A/Brisbane/10/2010, wild type)A/Switzerland/9715293/2013 (H3N2) - like strain(A/South Australia/55/2014, wild type)B/Phuket/3073/2013–like strain(B/Utah/9/2014, wild type)
|
| International non-proprietary name (INN) or common name |
influenza vaccine (surface antigen, inactivated, prepared in cell cultures)
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
J07BB02
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
Seqirus GmbH
|
| Revision |
16
|
| Date of issue of marketing authorisation valid throughout the European Union |
01/06/2007
|
| Contact address | |
Product information
12/12/2016 Optaflu - EMEA/H/C/000758 - T/0091
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 for adults, especially in those who run an increased risk of associated complications.
Optaflu should be used in accordance to official guidance.