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Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals
Auth. number : EU/1/08/478
INN : Prepandemic 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: Active immunisation against H5N1 subtype of Influenza A virus.
This indication is based on immunogenicity data from healthy subjects from the age of 18 years onwards following administration of two doses of vaccine prepared from A/VietNam/1194/2004 NIBRG-14 (H5N1) (see section 5.1).
Prepandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted) GlaxoSmithKline Biologicals 3.75 μg 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 continues to be 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
30/09/2008 Centralised - Authorisation EMEA/H/C/1015 (2008)5588 of 26/09/2008
05/02/2009 Centralised - Variation EMEA/H/C/1015/IA/5
Updated with Decision(2009)5595 of 07/07/2009
27/05/2009 Centralised - Variation EMEA/H/C/1015/II/6
01/07/2009 Centralised - Variation EMEA/H/C/1015/II/10
01/07/2009 Centralised - Variation EMEA/H/C/1015/II/9
09/07/2009 Centralised - Variation EMEA/H/C/1015/II/1, 2, 7 (2009)5595 of 07/07/2009
14/09/2009 Centralised - Variation EMEA/H/C/1015/IB/14
16/09/2009 Centralised - Variation EMEA/H/C/1015/II/12
16/09/2009 Centralised - Variation EMEA/H/C/1015/II/11
01/10/2009 Centralised - Variation EMEA/H/C/1015/IB/16
07/10/2009 Centralised - Variation EMEA/H/C/1015/II/8
07/10/2009 Centralised - Variation EMEA/H/C/1015/II/15
09/11/2009 Centralised - Variation EMEA/H/C/1015/II/13 (2009)8713 of 05/11/2009
29/06/2010 Centralised - Variation EMEA/H/C/1015/IB/17
05/10/2011 Centralised - Withdrawal (2011)7175 of 03/10/2011