Intanza

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Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

The marketing authorisation for Intanza has been withdrawn at the request of the marketing authorisation holder.

Intanza : EPAR - Summary for the public

English (EN) (547.43 KB - PDF)

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български (BG) (637.89 KB - PDF)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

First published: 07/04/2009Last 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: 28/04/2009Last updated: 04/09/2018
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español (ES) (1 MB - PDF)

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

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

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

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

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

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

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

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

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

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

First published: 28/04/2009Last updated: 04/09/2018
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lietuvių kalba (LT) (891.45 KB - PDF)

First published: 28/04/2009Last updated: 04/09/2018
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magyar (HU) (1.44 MB - PDF)

First published: 28/04/2009Last updated: 04/09/2018
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Malti (MT) (1.5 MB - PDF)

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

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

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

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

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

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

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

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

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

First published: 28/04/2009Last 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: 07/04/2009Last updated: 04/09/2018
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español (ES) (540.21 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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čeština (CS) (546.42 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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dansk (DA) (539.59 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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Deutsch (DE) (531.18 KB - PDF)

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

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

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

First published: 07/04/2009Last updated: 04/09/2018
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hrvatski (HR) (543.3 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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íslenska (IS) (540.06 KB - PDF)

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

italiano (IT) (540.42 KB - PDF)

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

latviešu valoda (LV) (557.31 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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lietuvių kalba (LT) (524.28 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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magyar (HU) (556.81 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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Malti (MT) (549.14 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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Nederlands (NL) (531.06 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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norsk (NO) (530.41 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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polski (PL) (548.37 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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português (PT) (530.41 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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română (RO) (532.7 KB - PDF)

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

slovenčina (SK) (548.64 KB - PDF)

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

slovenščina (SL) (544.53 KB - PDF)

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

Suomi (FI) (538.06 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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svenska (SV) (529.92 KB - PDF)

First published: 07/04/2009Last updated: 04/09/2018
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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
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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More information on Intanza

Public statement on Intanza: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/567363/2018

English (EN) (65.77 KB - PDF)

First published: Last updated:
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