Intanza

influenza vaccine (split virion, inactivated)

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This is a summary of the European public assessment report (EPAR) for Intanza. 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 Intanza.

What is Intanza?

Intanza is a vaccine, which is available as a suspension for injection in a pre‑filled syringe. The vaccine contains fragments of influenza (flu) viruses that have been inactivated (treated to prevent them causing infection). Intanza contains 15 micrograms of each of three different strains (varieties) of influenza virus (an H1N1 subtype, A/California/7/2009, NYMC X-179A; an H3N2 subtype, A/Hong Kong/4801/2014, NYMC X-263B; and a type B, B/Brisbane/60/2008, wild type).

What is Intanza used for?

Intanza is used to vaccinate adults aged 60 years and over 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 Intanza used?

Intanza is given as one ‘intradermal’ injection into the upper layer of the skin, using a special micro-injection system. The shoulder is the recommended site of injection.

How does Intanza work?

Intanza is a vaccine. Vaccines work by ‘teaching’ the immune system (the body’s natural defences) how to defend itself against a disease. Intanza contains fragments from 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 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. Fragments 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 Intanza before the vaccine can be used.

How has Intanza been studied?

The ability of Intanza to trigger the production of antibodies (immunogenicity) was first assessed in five main studies involving almost 9,000 people. Three studies looked at people aged 60 years and over, who were vaccinated with the 15-microgram strength. Two other studies looked at use of a lower strength in people under the age of 60.

In all studies, Intanza was compared with another flu vaccine given by injection into a muscle. In one study in people aged 60 years and over, Intanza was compared with a flu vaccine containing an adjuvant (a compound added to enhance the immune response). The studies compared the ability of the 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 Intanza shown during the studies?

In the five original studies, both Intanza and the comparator vaccine brought about adequate levels of antibodies for protection against all three flu strains. In people aged 60 years and over, the 15-microgram strength provided as good a level of protection as the comparator vaccines.

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

What is the risk associated with Intanza?

The most common side effects with Intanza (seen in more than 1 patient in 10) are headache, muscle pain  and local reactions at the site of the vaccination (redness, swelling, hardening of the skin, pain and itching). For the full list of all side effects reported with Intanza, see the package leaflet.

Intanza must not be used in people who are hypersensitive (allergic) to the active substances, to any of the other ingredients, or to any component that may be present in very small amounts such as egg (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol 9. People who have a fever or an acute (short-lived) infection should not receive the vaccine until they have recovered.

Why has Intanza been approved?

The CHMP decided that Intanza’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 Intanza?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intanza have been included in the summary of product characteristics and the package leaflet.

Other information about Intanza

The European Commission granted a marketing authorisation valid throughout the EU for Intanza on 24 February 2009.

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

Name Language First published Last updated
Intanza : EPAR - Summary for the public BG = bălgarski 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public ES = español 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public CS = čeština 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public DA = dansk 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public DE = Deutsch 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public ET = eesti keel 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public EL = elliniká 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public EN = English 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public FR = français 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public IT = italiano 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public LV = latviešu valoda 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public LT = lietuvių kalba 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public HU = magyar 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public MT = Malti 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public NL = Nederlands 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public PL = polski 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public PT = português 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public RO = română 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public SK = slovenčina 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public SL = slovenščina 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public FI = suomi 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public SV = svenska 2009-04-07 2016-09-30
Intanza : EPAR - Summary for the public HR = Hrvatski 2009-04-07 2016-09-30

This EPAR was last updated on 21/11/2016 .

Authorisation details

Product details

Product details for Intanza
NameIntanza
Agency product numberEMEA/H/C/000957
Active substance

A/California/7/2009 (H1N1)PDM09 - Derived strain used NYMC x-179a / A/Perth/16/2009 (H3N2) - like strain (A/Victoria/210/2009 reass. NYMC x-187) / B/Brisbane/60/2008

International non-proprietary name (INN) or common name

influenza vaccine (split virion, inactivated)

Therapeutic area Influenza, HumanImmunization
Anatomical therapeutic chemical (ATC) code J07BB02

Publication details

Publication details for Intanza
Marketing-authorisation holder

Sanofi Pasteur Europe

Revision16
Date of issue of marketing authorisation valid throughout the European Union24/02/2009

Contact address:

Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon
France

Product information

Product information

03/11/2016  Intanza -EMEA/H/C/000957 - T/0051

Name Language First published Last updated
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21
Intanza : EPAR - Product Information HR = Hrvatski 2009-04-28 2016-11-21

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
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30
Intanza : EPAR - All Authorised presentations HR = Hrvatski 2009-04-07 2016-09-30

Pharmacotherapeutic group

Vaccines

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Intanza : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 2009-05-11 2016-11-21

Initial marketing-authorisation documents

Name Language First published Last updated
Intanza : EPAR - Public assessment report HR = Hrvatski 2009-04-07  
Committee for medicinal products for human use, summary of positive opinion for Intanza HR = Hrvatski 2008-12-18  

Authorised

This medicine is approved for use in the European Union