Intanza

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Withdrawn

This medicine's authorisation has been withdrawn

influenza vaccine (split virion, inactivated)
Medicine Human Withdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 3 August 2018, the European Commission withdrew the marketing authorisation for Intanza (influenza vaccine (split virion, inactivated)) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Pasteur Europe, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Intanza was granted marketing authorisation in the EU on 24 February 2009 for prophylaxis of influenza in individuals 60 years of age and over. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2013. There are other medicinal products similar to Intanza authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Intanza is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Intanza : EPAR - Summary for the public

English (EN) (547.43 KB - PDF)

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български (BG) (637.89 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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español (ES) (545.64 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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čeština (CS) (611.73 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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dansk (DA) (545.52 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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Deutsch (DE) (547.47 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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eesti keel (ET) (552.93 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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ελληνικά (EL) (635.18 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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français (FR) (547.7 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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hrvatski (HR) (567.46 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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italiano (IT) (544.82 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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latviešu valoda (LV) (610.29 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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lietuvių kalba (LT) (570.94 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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magyar (HU) (605.73 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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Malti (MT) (615.9 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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Nederlands (NL) (545.14 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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polski (PL) (608.34 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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português (PT) (545.74 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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română (RO) (571.27 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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slovenčina (SK) (613.61 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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slovenščina (SL) (601.13 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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Suomi (FI) (544.59 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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svenska (SV) (545.64 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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Product information

Intanza : EPAR - Product Information

English (EN) (1.04 MB - PDF)

First published: Last updated:
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български (BG) (1.47 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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español (ES) (1 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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čeština (CS) (1.31 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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dansk (DA) (974.04 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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Deutsch (DE) (1.01 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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eesti keel (ET) (965.77 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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ελληνικά (EL) (1.7 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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français (FR) (839.69 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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hrvatski (HR) (992.86 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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íslenska (IS) (1.02 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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italiano (IT) (951.14 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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latviešu valoda (LV) (1.25 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
View

lietuvių kalba (LT) (891.45 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
View

magyar (HU) (1.44 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
View

Malti (MT) (1.5 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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Nederlands (NL) (980.56 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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norsk (NO) (1004.45 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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polski (PL) (1.22 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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português (PT) (783.19 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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română (RO) (875.4 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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slovenčina (SK) (1.6 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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slovenščina (SL) (1.53 MB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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Suomi (FI) (785.83 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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svenska (SV) (779.44 KB - PDF)

First published: 28/04/2009 Last updated: 04/09/2018
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Latest procedure affecting product information:II/0054
07/09/2017
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Intanza : EPAR - All Authorised presentations

English (EN) (509.45 KB - PDF)

First published: Last updated:
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български (BG) (566.72 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

español (ES) (540.21 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

čeština (CS) (546.42 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

dansk (DA) (539.59 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

Deutsch (DE) (531.18 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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eesti keel (ET) (539.24 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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ελληνικά (EL) (567.85 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
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français (FR) (506.88 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

hrvatski (HR) (543.3 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

íslenska (IS) (540.06 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

italiano (IT) (540.42 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

latviešu valoda (LV) (557.31 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

lietuvių kalba (LT) (524.28 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

magyar (HU) (556.81 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

Malti (MT) (549.14 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

Nederlands (NL) (531.06 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

norsk (NO) (530.41 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

polski (PL) (548.37 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

português (PT) (530.41 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

română (RO) (532.7 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

slovenčina (SK) (548.64 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

slovenščina (SL) (544.53 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

Suomi (FI) (538.06 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

svenska (SV) (529.92 KB - PDF)

First published: 07/04/2009 Last updated: 04/09/2018
View

Product details

Name of medicine
Intanza
Active substance
influenza virus (inactivated, split) of the following strains:A/California/7/2009 (H1N1)pdm09 - like strain (A/California/7/2009, NYMC X-179A)A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)
International non-proprietary name (INN) or common name
influenza vaccine (split virion, inactivated)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
Anatomical therapeutic chemical (ATC) code
J07BB02

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.

Authorisation details

EMA product number
EMEA/H/C/000957
Marketing authorisation holder
Sanofi Pasteur Europe

2 Avenue Pont Pasteur
69007 Lyon
France

Marketing authorisation issued
24/02/2009
Withdrawal of marketing authorisation
03/08/2018
Revision
18

Assessment history

Intanza : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (817.35 KB - PDF)

First published: Last updated:
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Intanza : EPAR - Public assessment report

English (EN) (1.11 MB - PDF)

First published: Last updated:
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Committee for medicinal products for human use, summary of positive opinion for Intanza

Reference Number: EMEA/CHMP/642748/2008

English (EN) (487.73 KB - PDF)

First published: Last updated:
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