Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Fendrix   
Auth. number : EU/1/04/299
INN : Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed)
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07B - Viral vaccines
Chemical subgroup: J07BC - Hepatitis vaccines
Chemical substance: J07BC01 - Hepatitis B, purified antigen
(See WHO ATC Index)
Indication: indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes for patients with renal insufficiency (including pre-haemodialysis and haemodialysis patients), from the age of 15 years onwards
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
04/02/2005 Centralised - Authorisation EMEA/H/C/550 (2005)290 of 02/02/2005
26/09/2005 Centralised - Variation EMEA/H/C/550/II/1
22/11/2005 Centralised - Variation EMEA/H/C/550/II/2
07/02/2006 Centralised - Variation EMEA/H/C/550/N/3
Updated with Decision(2009)1583 of 02/03/2009
22/11/2006 Centralised - Variation EMEA/H/C/550/II/4
03/05/2007 Centralised - Variation EMEA/H/C/550/II/5
27/01/2009 Centralised - Variation EMEA/H/C/550/II/6
04/03/2009 Centralised - Variation EMEA/H/C/550/II/7 (2009)1583 of 02/03/2009
27/04/2009 Centralised - Variation EMEA/H/C/550/II/8
07/05/2009 Centralised - Variation EMEA/H/C/550/IA/11
05/06/2009 Centralised - Variation EMEA/H/C/550/II/9
30/06/2009 Centralised - Variation EMEA/H/C/550/II/10
18/08/2009 Centralised - Variation EMEA/H/C/550/IB/13
14/12/2009 Centralised - Renewal EMEA/H/C/550/R/12 (2009)10232 of 10/12/2009
02/08/2010 Centralised - Variation EMEA/H/C/550/II/14 (2010)5392 of 28/07/2010
29/03/2011 Centralised - Variation EMEA/H/C/550/IG/51/G
21/12/2011 Centralised - Variation EMEA/H/C/550/WS/153 (2011)9941 of 19/12/2011
19/12/2013 Centralised - Variation EMEA/H/C/550/IAIN/31