- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On the 23 March 2010 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Arepanrix, pandemic influenza vaccine (H1N1)v (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 Arepanrix was GlaxoSmithKline Biologicals S.A. The European Commission was notified by a letter dated 22 November 2010 of the MAH’s decision to voluntarily withdraw the marketing authorisation as of the Commission Decision date for Arepanrix for commercial reasons. Arepanrix was not marketed in any European country.
On 13 December 2010 the European Commission issued a decision to withdraw the marketing authorisation for Arepanrix. Pursuant to this decision the European Public Assessment Report for Arepanrix is updated to reflect that the marketing authorisation is no longer valid.
Product information
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).
Product details
- Name of medicine
- Arepanrix
- 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)v (split virion, inactivated, adjuvanted)
- Therapeutic area (MeSH)
- Influenza, Human
- Immunization
- Disease Outbreaks
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
Influenza vaccinesTherapeutic indication
Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance