Optaflu

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

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The marketing authorisation for Optaflu has expired following the marketing authorisation holder's decision not to apply for a renewal.

Name Language First published Last updated
Optaflu : EPAR - Summary for the public BG = bălgarski 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public ES = español 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public CS = čeština 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public DA = dansk 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public DE = Deutsch 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public ET = eesti keel 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public EL = elliniká 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public EN = English 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public FR = français 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public IT = italiano 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public LV = latviešu valoda 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public LT = lietuvių kalba 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public HU = magyar 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public MT = Malti 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public NL = Nederlands 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public PL = polski 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public PT = português 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public RO = română 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public SK = slovenčina 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public SL = slovenščina 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public FI = suomi 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public SV = svenska 2008-02-21 2015-12-02
Optaflu : EPAR - Summary for the public HR = Hrvatski 2008-02-21 2015-12-02

This EPAR was last updated on 27/06/2017 .

Authorisation details

Product details

Product details for Optaflu
NameOptaflu
Agency product numberEMEA/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 Influenza, HumanImmunization
Anatomical therapeutic chemical (ATC) code J07BB02

Publication details

Publication details for Optaflu
Marketing-authorisation holder

Seqirus GmbH

Revision16
Date of issue of marketing authorisation valid throughout the European Union01/06/2007

Contact address:

Seqirus GmbH
Emil-von-Behring Strasse 76
35041 Marburg
Germany

Product information

Product information

12/12/2016  Optaflu -EMEA/H/C/000758 -T/0091

Name Language First published Last updated
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13
Optaflu : EPAR - Product Information HR = Hrvatski 2009-05-11 2017-02-13

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.


Name Language First published Last updated
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 2008-09-12 2015-09-22

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Optaflu : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2007-08-01  
Optaflu : EPAR - Scientific Discussion HR = Hrvatski 2007-08-01  

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Optaflu