Humenza

Withdrawn

This medicine's authorisation has been withdrawn

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

Overview

On 8 June 2010 the European Commission issued a conditional marketing authorisation valid throughout the European Union for the medicinal product Humenza (pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)), which had been approved for prophylaxis of influenza in an officially declared pandemic situation. The marketing authorisation holder (MAH) responsible for Humenza was Sanofi Pasteur S.A. 

The European Commission was notified by a letter dated 5 May 2011 of the MAH’s decision to voluntarily withdraw the marketing authorisation for commercial reasons. Humenza was not marketed in any EU country. 

On 14 June 2011 the European Commission issued a decision to withdraw the marketing authorisation for Humenza. 

Pursuant to this decision the European Public Assessment Report for Humenza is updated to reflect that the marketing authorisation is no longer valid.

Humenza : EPAR - Summary for the public

Product information

Humenza : EPAR - Product Information

Humenza : EPAR - All Authorised presentations

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
• Withdrawal of marketing authorisation:
  14/06/2011

Assessment history

Initial marketing authorisation documents

Humenza : EPAR - Public assessment report

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

AdoptedReference Number: EMA/CHMP/31616/2010