Optaflu

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

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This is a summary of the European public assessment report (EPAR) for Optaflu. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Optaflu.

What is Optaflu?

Optaflu is a vaccine, which is available as a suspension for injection in a pre-filled syringe. The vaccine contains ‘surface antigens’ from three different strains (types) of influenza (flu) virus: A/California/7/2009 (H1N1)pdm09-like strain; A/Switzerland/9715293/2013 (H3N2)–like strain; and B/Phuket/3073/2013-like strain.

What is Optaflu used for?

Optaflu is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications from the disease. The use of the vaccine should be based on official recommendations.

The vaccine can only be obtained with a prescription.

How is Optaflu used?

Optaflu is given as one injection of 0.5 ml into the muscle at the top of the arm.

How does Optaflu work?

Optaflu is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Optaflu contains fragments from the surface of three different strains of flu virus. When a person is given the vaccine, the immune system recognises the virus fragments as ‘foreign’ and makes antibodies against them. In the future, the immune system will be able to produce antibodies more quickly when it is exposed to any of these virus strains. The antibodies will then help to protect against the disease caused by these strains of the flu virus.

Each year, the World Health Organization (WHO) makes recommendations on which flu strains should be included in vaccines for the upcoming flu season. Optaflu contains fragments (surface antigens) of the virus strains that are expected to cause flu in the upcoming season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU), need to be included in Optaflu before the vaccine can be used.

The viruses used to obtain the surface antigen that are included in Optaflu are grown in mammalian cells, unlike those used for other flu vaccines, which are grown in hen’s eggs.

How has Optaflu been studied?

The ability of Optaflu to trigger the production of antibodies (immunogenicity) was first assessed using a formulation of the vaccine that included the virus strains expected to cause flu in the 2004/2005 season. The vaccine’s effectiveness was assessed in one main study involving 2,654 adults, around half of whom were elderly (over 60 years of age). The effects of Optaflu were compared to those of a similar flu vaccine that was made in eggs. The study compared the ability of the two vaccines to trigger the production of antibodies (immunogenicity), by comparing antibody levels before injection and three weeks afterwards.

The immunogenicity and safety of subsequent formulations of the vaccine have also been examined in studies.

What benefit has Optaflu shown during the studies?

In the original main study, both Optaflu and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains, as defined in criteria laid down by the CHMP for flu vaccines. The two vaccines were similar in triggering the production of antibodies, both in adults 60 years of age and below, and in the elderly.

Later seasonal formulations of Optaflu have been shown to bring about similar antibody responses against the three flu strains included in the vaccine to those seen in the main study.

What is the risk associated with Optaflu?

The most common side effects with Optaflu (seen in more than 1 patient in 10) are headache, reddening of the skin, muscle pain, pain at the site of injection, malaise (feeling unwell) and fatigue (tiredness). These side effects usually disappear within one to two days without treatment. For the full list of all side effects reported with Optaflu, see the package leaflet.

People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered. For the full list of restrictions, see the package leaflet.

Why has Optaflu been approved?

The CHMP decided that Optaflu’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Optaflu?

A risk management plan has been developed to ensure that Optaflu is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Optaflu, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Optaflu

The European Commission granted a marketing authorisation valid throughout the European Union for Optaflu on 1 June 2007.

For more information about treatment with Optaflu, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

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

This EPAR was last updated on 18/03/2016 .

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 used A/Brisbane/10/2010 wild type Victoria/361/2011 (H3N2) - like strain used (NYMC X-223A) derived from A/Texas/50/2012 B/Massachusetts/2/2012

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

Novartis Influenza Vaccines Marburg GmbH

Revision15
Date of issue of marketing authorisation valid throughout the European Union01/06/2007

Contact address:

Novartis Influenza Vaccines Marburg GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany

Product information

Product information

22/01/2016  Optaflu -EMEA/H/C/000758 -PSUSA/1745/201504

Name Language First published Last updated
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016
Optaflu : EPAR - Product Information HR = Hrvatski 11/05/2009 18/03/2016

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 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015
Optaflu : EPAR - All Authorised presentations HR = Hrvatski 12/09/2008 22/09/2015

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 01/08/2007  
Optaflu : EPAR - Scientific Discussion HR = Hrvatski 01/08/2007  

Authorised

This medicine is approved for use in the European Union