Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Adjupanrix   
Auth. number : EU/1/09/578
INN : Purified antigen fractions of inactivated split virions A/VietNam/1194/2004 NIBRG-14 (H5N1)
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. Pandemic influenza vaccine should be used in accordance with official guidance.
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
21/10/2009 Centralised - Authorisation EMEA/H/C/1206 (2009)8263 of 19/10/2009
29/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1206/IB/1
27/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1206/IB/2
03/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/1206/IA/3
23/02/2011 Centralised - Variation (refusal) EMEA/H/C/1206/IG/33/G
21/04/2011 Centralised - Variation EMEA/H/C/1206/II/4 (2011)2857 of 18/04/2011
26/08/2011 Centralised - Variation EMEA/H/C/1206/IB/9
Updated with Decision(2011)8673 of 22/11/2011
24/11/2011 Centralised - Variation EMEA/H/C/1206/II/11 (2011)8673 of 22/11/2011
27/12/2011 Centralised - Variation EMEA/H/C/1206/WS/153, 161/G (2011)10090 of 22/12/2011
20/06/2012 Centralised - Variation EMEA/H/C/1206/IA/25
Updated with Decision(2012)7997 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7997 of 31/10/2012
04/03/2014 Centralised - Modification EMEA/H/C/1206/PSUV/32 (2014)1461 of 28/02/2014
06/03/2014 Centralised - Variation EMEA/H/C/1206/IB/33/G
Updated with Decision(2014)3533 of 22/05/2014
27/05/2014 Centralised - 2-Monthly update EMEA/H/C/1206/II/35 (2014)3533 of 22/05/2014
26/06/2014 Centralised - Variation EMEA/H/C/1206/II/34
22/07/2014 Centralised - Renewal EMEA/H/C/1206/R/36 (2014)5252 of 18/07/2014