Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: HBVAXPRO   
Auth. number : EU/1/01/183
INN : Recombinant Hepatitis B virus small surface antigen (HbsAg)
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: This vaccine is indicated for active immunisation against hepatitis B virus infection caused by all known subtypes in children and adolescents (from birth through 15 years of age) considered at risk of exposure to hepatitis B virus.The specific at risk categories to be immunised are to be determined on the basis of the official recommendations.It can be expected that hepatitis D will also be prevented by immunisation with HBVAXPRO as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC
8 rue Jonas Salk, F-69007 Lyon, France

  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
04/05/2001 Centralised - Authorisation EMEA/H/C/373 (2001)873 of 27/04/2001
16/11/2001 Centralised - Variation EMEA/H/C/373/I/1 (2001)3539 of 15/11/2001
28/11/2001 Centralised - Variation EMEA/H/C/373/I/3
10/12/2001 Centralised - Variation EMEA/H/C/373/I/2
29/10/2002 Centralised - Variation EMEA/H/C/373/N/4 (2002)4292 of 23/10/2002
07/07/2004 Centralised - Variation EMEA/H/C/373/IA/6
Updated with Decision(2005)1061 of 29/03/2005
03/08/2004 Centralised - Variation EMEA/H/C/373/II/5
11/03/2005 Centralised - Variation EMEA/H/C/373/IA/8
Updated with Decision(2005)1345 of 25/04/2005
31/03/2005 Centralised - Variation (2005)1061 of 29/03/2005
27/04/2005 Centralised - Variation EMEA/H/C/373/II/7 (2005)1345 of 25/04/2005
20/07/2005 Centralised - Variation EMEA/H/C/373/IB/9
Updated with Decision(2006)506 of 13/02/2006
20/07/2005 Centralised - Variation EMEA/H/C/373/IA/13
Updated with Decision(2006)506 of 13/02/2006
20/07/2005 Centralised - Variation EMEA/H/C/373/IA/12
Updated with Decision(2006)506 of 13/02/2006
29/09/2005 Centralised - Variation EMEA/H/C/373/II/11
24/11/2005 Centralised - Variation EMEA/H/C/373/II/10
16/02/2006 Centralised - Variation (2006)506 of 13/02/2006
03/07/2006 Centralised - Variation EMEA/H/C/373/IA/17
04/08/2006 Centralised - Variation EMEA/H/C/373/IB/18
08/08/2006 Referral EMEA/H/C/373/A-20 (2006)3636 of 04/08/2006
08/08/2006 Centralised - Renewal EMEA/H/C/373/R/14 (2006)3637 of 04/08/2006
23/08/2006 Centralised - Variation EMEA/H/C/373/II/16 (2006)3836 of 21/08/2006
31/08/2006 Centralised - Variation EMEA/H/C/373/IB/19
14/03/2007 Centralised - Variation EMEA/H/C/373/N/20
Updated with Decision(2007)6873 of 21/12/2007
18/12/2007 Centralised - Variation EMEA/H/C/373/IA/23, 24, 25
Updated with Decision(2008)6047 of 13/10/2008
26/12/2007 Centralised - Variation EMEA/H/C/373/II/22 (2007)6873 of 21/12/2007
31/01/2008 Centralised - Variation EMEA/H/C/373/II/21
29/04/2008 Centralised - Variation EMEA/H/C/373/II/26
15/10/2008 Centralised - Variation (2008)6047 of 13/10/2008
22/01/2010 Centralised - Variation EMEA/H/C/373/II/27 (2010)412 of 20/01/2010
07/04/2010 Centralised - Variation EMEA/H/C/373/IA/28/G
Updated with Decision(2010)6100 of 31/08/2010
02/09/2010 Centralised - Variation EMEA/H/C/373/IA/28/G (2010)6100 of 31/08/2010
22/03/2011 Centralised - Renewal EMEA/H/C/373/R/29 (2011)1878 of 17/03/2011
28/03/2011 Centralised - Variation EMEA/H/C/373/II/30 (2011)2079 of 24/03/2011
29/04/2011 Centralised - Variation EMEA/H/C/373/II/31
31/08/2011 Centralised - Variation EMEA/H/C/373/II/33 (2011)6237 of 26/08/2011
18/07/2012 Centralised - Variation EMEA/H/C/373/N/37
11/07/2013 Centralised - Variation EMEA/H/C/373/N/38
12/03/2014 Centralised - Variation EMEA/H/C/373/IB/40