Humenza

pandemic influenza vaccine (H1N1, split virion, inactivated, adjuvanted)

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The marketing authorisation for Humenza has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Humenza : EPAR - Summary for the public BG = bălgarski 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public ES = español 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public CS = čeština 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public DA = dansk 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public DE = Deutsch 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public ET = eesti keel 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public EL = elliniká 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public EN = English 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public FR = français 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public IT = italiano 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public LV = latviešu valoda 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public LT = lietuvių kalba 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public HU = magyar 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public MT = Malti 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public NL = Nederlands 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public PL = polski 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public PT = português 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public RO = română 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public SK = slovenčina 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public SL = slovenščina 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public FI = suomi 2010-07-08 2011-06-30
Humenza : EPAR - Summary for the public SV = svenska 2010-07-08 2011-06-30

This EPAR was last updated on 30/06/2011 .

Authorisation details

Product details

Product details for Humenza
NameHumenza
Agency product numberEMEA/H/C/001202
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 Influenza, HumanImmunizationDisease Outbreaks
Anatomical therapeutic chemical (ATC) code J07BB02
Conditional Approval

Sometimes, the CHMP recommends that a medicine be given ‘conditional approval’. This happens when the Committee has based its positive opinion on data which, while not yet comprehensive, indicate that the medicine’s benefits outweigh its risks.

The company is given obligations to fulfil, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a normal approval. Conditional approvals can only be granted for medicines that satisfy an ‘unmet medical need’, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.

Publication details

Publication details for Humenza
Marketing-authorisation holder

Sanofi Pasteur S.A.

Revision0
Date of issue of marketing authorisation valid throughout the European Union08/06/2010

Contact address:

Sanofi Pasteur S.A.
2, avenue Pont Pasteur
FR-69007 Lyon
France

Product information

Product information

14/06/2011  Humenza -EMEA/H/C/001202 --

Name Language First published Last updated
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - Product Information SV = svenska 2010-07-08 2011-06-30

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
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30
Humenza : EPAR - All Authorised presentations SV = svenska 2010-07-08 2011-06-30

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Humenza : EPAR - Public assessment report SV = svenska 2010-07-08 2011-06-30
Committee for Medicinal Products for Human Use positive summary of opinion for Humenza SV = svenska 2010-02-19 2011-06-30

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Humenza