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 (killed). Intanza contains three different strains (types) of influenza virus (A/California/7/2009 (H1N1)pdm09-derived strain, A/Victoria/361/2011 (H3N2)-like strain and B/Massachusetts/02/2012).

What is Intanza used for?

Intanza is used to vaccinate adults against flu, especially those who are at an increased risk of developing complications of the disease. The use of the vaccine should be based on official recommendations. Adults up to the age of 59 years receive the lower strength (containing 9 micrograms of each virus strain). People aged 60 years and over receive the higher strength (15 micrograms of each virus strain).

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. These virus strains need to be included in Intanza before the vaccine can be used. Intanza currently contains fragments of the virus strains that are expected to cause flu in the 2013/2014 season, according to the recommendations from the WHO for the northern hemisphere and from the European Union (EU). The virus strains in Intanza will need to be replaced again before the vaccine can be used in subsequent seasons.

How has Intanza been studied?

The effectiveness of Intanza was first assessed in five main studies involving almost 9,000. Two of the studies looked at people under the age of 60 years, who were vaccinated with the 9‑microgram strength. The other three studies looked at people aged 60 years and over, who were vaccinated with the 15‑microgram strength.

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 the current formulation of the vaccine has been confirmed in 130 adults, 65 of whom were aged 60 years or older.

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 adults below 60 years, the 9‑microgram strength provided as good a level of protection as the intramuscular vaccine. In people aged 60 years and over, the 15‑microgram strength provided as good a level of protection as the comparator vaccines.

The current formulation of Intanza for the 2013/2014 season brought 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, myalgia (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.

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 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public ES = español 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public CS = čeština 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public DA = dansk 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public DE = Deutsch 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public ET = eesti keel 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public EL = elliniká 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public EN = English 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public FR = français 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public IT = italiano 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public LV = latviešu valoda 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public LT = lietuvių kalba 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public HU = magyar 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public MT = Malti 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public NL = Nederlands 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public PL = polski 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public PT = português 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public RO = română 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public SK = slovenčina 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public SL = slovenščina 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public FI = suomi 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public SV = svenska 07/04/2009 18/10/2013
Intanza : EPAR - Summary for the public HR = Hrvatski 07/04/2009 18/10/2013

This EPAR was last updated on 29/09/2014 .

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
A/Victoria/361/2011 (H3N2)-like strain
B/Massachusetts/02/2012

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 MSD, SNC

Revision12
Date of issue of marketing authorisation valid throughout the European Union24/02/2009

Contact address:

Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès
69007 Lyon
France

Product information

Product information

06/08/2014  Intanza -EMEA/H/C/000957 -II/0029

Name Language First published Last updated
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014
Intanza : EPAR - Product Information HR = Hrvatski 28/04/2009 29/09/2014

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 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  
Intanza : EPAR - All Authorised presentations HR = Hrvatski 07/04/2009  

Pharmacotherapeutic group

Vaccines

Therapeutic indication

9 micrograms/strain

Prophylaxis of influenza in adults up to 59 years of age, especially in those who run an increased risk of associated complications.

The use of Intanza should be based on official recommendations.

15 micrograms/strain

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 11/05/2009 29/09/2014

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union