Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Pumarix   
Auth. number : EU/1/10/664
INN : Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BB - Influenza vaccines
Chemical substance: J07BB02 - Influenza, purified antigen
(See WHO ATC Index)
Indication: Prophylaxis of influenza in an officially declared pandemic situation
Marketing Authorisation Holder: GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
08/03/2011 Centralised - Authorisation EMEA/H/C/1212 (2011)1605 of 04/03/2011
11/01/2012 Centralised - Variation EMEA/H/C/1212/WS/153 (2012)92 of 09/01/2012
22/08/2012 Centralised - Variation EMEA/H/C/1212/IB/4
Updated with Decision(2012)7924 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7924 of 29/10/2012
03/03/2014 Centralised - Modification EMEA/H/C/1212/PSUV/9 (2014)1475 of 28/02/2014