Overview
The marketing authorisation for Pumarix has been withdrawn at the request of the marketing authorisation holder.
Pumarix : EPAR - Summary for the public
Product information
Pumarix : EPAR - Product Information
Latest procedure affecting product information: P46/0016
28/02/2014
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).
Pumarix : EPAR - All Authorised presentations
Product details
- Name of medicine
- Pumarix
- Active substance
- pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
- International non-proprietary name (INN) or common name
- pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
- Therapeutic area (MeSH)
- Influenza, Human
- Immunization
- Disease Outbreaks
- Anatomical therapeutic chemical (ATC) code
- J07BB02
Pharmacotherapeutic group
VaccinesTherapeutic indication
Prophylaxis of influenza in an officially declared pandemic situation.
Pandemic-influenza vaccine should be used in accordance with official guidance.
Assessment history
Pumarix : EPAR - Procedural steps taken and scientific information after authorisation
Pumarix-H-C-1212-P46-0016 : EPAR - Assessment Report
Pumarix-H-C-1212-PSUV-0009 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation