Optaflu

RSS

influenza vaccine (surface antigen, inactivated, prepared in cell cultures)

Withdrawn
This medicine is now withdrawn from use in the European Union.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)
  • Influenza, Human
  • Immunization
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
Emil-von-Behring Strasse 76
35041 Marburg
Germany

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Vaccines

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.

Assessment history

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