Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Prepandrix   
Auth. number : EU/1/08/453
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 with H5N1 subtype strains.
Prepandrix 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
16/05/2008 Centralised - Authorisation EMEA/H/C/822 (2008)1964 of 14/05/2008
31/07/2008 Centralised - Variation EMEA/H/C/822/IA/2
Updated with Decision(2009)3135 of 21/04/2009
15/12/2008 Centralised - Variation EMEA/H/C/822/II/1
23/04/2009 Centralised - Variation (2009)3135 of 21/04/2009
01/07/2009 Centralised - Variation EMEA/H/C/822/II/8
08/07/2009 Centralised - Variation EMEA/H/C/822/II/5, 6, 9 (2009)5594 of 07/07/2009
11/08/2009 Centralised - Variation EMEA/H/C/822/X/4 (2009)6381 of 07/08/2009
04/09/2009 Centralised - Variation EMEA/H/C/822/II/12
04/09/2009 Centralised - Variation EMEA/H/C/822/II/11
14/09/2009 Centralised - Variation EMEA/H/C/822/IB/14
05/10/2009 Centralised - Variation EMEA/H/C/822/II/10
05/10/2009 Centralised - Variation EMEA/H/C/822/II/15
13/10/2009 Centralised - Variation EMEA/H/C/822/IB/16
21/10/2009 Centralised - Variation EMEA/H/C/822/II/13 (2009)8267 of 19/10/2009
29/06/2010 Centralised - Variation EMEA/H/C/822/IB/17
03/08/2010 Centralised - Variation EMEA/H/C/822/IB/24
Updated with Decision(2011)2948 of 20/04/2011
05/08/2010 Centralised - Variation EMEA/H/C/822/II/22
05/08/2010 Centralised - Variation EMEA/H/C/822/II/18
05/08/2010 Centralised - Variation EMEA/H/C/822/II/19
05/08/2010 Centralised - Variation EMEA/H/C/822/II/21
05/08/2010 Centralised - Variation EMEA/H/C/822/II/20
31/08/2010 Centralised - Variation EMEA/H/C/822/II/23 (2010)6020 of 26/08/2010
29/10/2010 Centralised - Variation EMEA/H/C/822/IB/25
02/03/2011 Centralised - Variation EMEA/H/C/822/IG/33/G
18/03/2011 Centralised - Variation EMEA/H/C/822/IG/52
28/04/2011 Centralised - Variation EMEA/H/C/822/II/26 (2011)2948 of 20/04/2011
24/11/2011 Centralised - Variation EMEA/H/C/822/II/29 (2011)8678 of 22/11/2011
27/12/2011 Centralised - Variation EMEA/H/C/822/WS/153, 161/G (2011)10082 of 22/12/2011
05/01/2012 Centralised - Variation EMEA/H/C/822/IB/39
Updated with Decision(2012)4708 of 03/07/2012
05/07/2012 Centralised - Variation (2012)4708 of 03/07/2012
17/01/2013 Centralised - Renewal EMEA/H/C/822/R/46 (2013)140 of 14/01/2013
04/03/2014 Centralised - Maintain EMEA/H/C/822/PSUV/49 (2014)1472 of 28/02/2014
06/03/2014 Centralised - Variation EMEA/H/C/822/IB/50/G
Updated with Decision(2014)3536 of 22/05/2014
27/05/2014 Centralised - Variation EMEA/H/C/822/II/52/G (2014)3536 of 22/05/2014
26/06/2014 Centralised - Variation EMEA/H/C/822/II/51