Overview

The marketing authorisation for Humenza has been withdrawn at the request of the marketing authorisation holder.

Humenza : EPAR - Summary for the public

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Product information

Humenza : EPAR - Product Information

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română (RO) (693.71 KB - PDF)
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slovenščina (SL) (997.09 KB - PDF)
Suomi (FI) (579.58 KB - PDF)
svenska (SV) (600.72 KB - PDF)

Latest procedure affecting product information: -

14/06/2011

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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).

Humenza : EPAR - All Authorised presentations

български (BG) (376.55 KB - PDF)
español (ES) (259.23 KB - PDF)
čeština (CS) (281.68 KB - PDF)
dansk (DA) (259.63 KB - PDF)
Deutsch (DE) (260.52 KB - PDF)
eesti keel (ET) (259.14 KB - PDF)
ελληνικά (EL) (295.04 KB - PDF)
français (FR) (259.21 KB - PDF)
italiano (IT) (257.88 KB - PDF)
latviešu valoda (LV) (283.41 KB - PDF)
lietuvių kalba (LT) (273.45 KB - PDF)
magyar (HU) (282.62 KB - PDF)
Malti (MT) (283.55 KB - PDF)
Nederlands (NL) (259.53 KB - PDF)
polski (PL) (283.89 KB - PDF)
português (PT) (259.46 KB - PDF)
română (RO) (270.81 KB - PDF)
slovenčina (SK) (281.75 KB - PDF)
slovenščina (SL) (263.79 KB - PDF)
Suomi (FI) (258.94 KB - PDF)
svenska (SV) (259.94 KB - PDF)

Product details

Name of medicine
Humenza
Active substance
split influenza virus, inactivated, containing antigen*: A/California/7/2009 (H1N1)v like strain (X-179A)*propagated in eggs.
International non-proprietary name (INN) or common name
pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Therapeutic area (MeSH)
  • Influenza, Human
  • Immunization
  • Disease Outbreaks
Anatomical therapeutic chemical (ATC) code
J07BB02

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Prophylaxis of influenza in an officially declared pandemic situation.

Pandemic influenza vaccine should be used in accordance with Official Guidance.

Authorisation details

EMA product number
EMEA/H/C/001202

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Marketing authorisation holder
Sanofi Pasteur S.A.

2, avenue Pont Pasteur
FR-69007 Lyon
France

Marketing authorisation issued
08/06/2010

Assessment history

Humenza : EPAR - Public assessment report

Committee for Medicinal Products for Human Use positive summary of opinion for Humenza

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