Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ambirix   
Auth. number : EU/1/02/224
Active substance : Inactivated hepatitis A virus, Hepatitis B surface antigen (rDNA)
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: J07BC20 - Combinations
(See WHO ATC Index)
Indication: Ambirix is indicated in non-immune children and adolescents from 1 year up to and including 15
years of age for protection against hepatitis A and hepatitis B infection.
Protection against hepatitis B infections may not be obtained until after the second dose.
Therefore:
- Ambirix should be used only when there is a relatively low risk of hepatitis B infection during
the vaccination course.
- It is recommended that Ambirix should be administered in settings where completion of the
two-dose vaccination course can be assured.
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
05/09/2002 Centralised - Authorisation EMEA/H/C/426 (2002)3319 of 30/08/2002
09/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/1
09/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/2
09/01/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/3
06/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/4
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/I/9
02/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/5
30/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/6
30/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/7
16/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IA/11
05/04/2004 Centralised - Variation EMEA/H/C/426/II/10 (2004)1327 of 31/03/2004
15/09/2005 Centralised - Notification EMEA/H/C/426/N/14
Updated with Decision(2007)16 of 03/01/2007
26/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/13
03/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/12
27/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/17
09/01/2007 Centralised - Variation EMEA/H/C/426/II/15 (2007)16 of 03/01/2007
11/09/2007 Centralised - Renewal EMEA/H/C/426/R/18 (2007)4255 of 07/09/2007
07/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IA/19
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IA/20
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IA/21
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IA/22
19/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IB/24
02/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/23
23/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IB/25
18/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IB/26
19/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/27
05/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/28
22/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/WS/1
29/09/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/30
02/11/2010 Centralised - Variation EMEA/H/C/426/II/32 (2010)7616 of 28/10/2010
01/12/2010 Centralised - Variation EMEA/H/C/426/II/29 (2010)8559 of 26/11/2010
04/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/II/31
23/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/IG/51/G
23/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/426/I/52/G
27/12/2011 Centralised - Variation EMEA/H/C/426/WS/153 (2011)10101 of 22/12/2011
08/02/2012 Centralised - Variation EMEA/H/C/426/II/34 (2012)762 of 06/02/2012
24/07/2012 Centralised - Renewal EMEA/H/C/426/R/42 (2012)5274 of 20/07/2012
12/12/2013 Centralised - Notification EMEA/H/C/426/N/53
Updated with Decision(2015)4853 of 08/07/2015
24/07/2014 Centralised - Variation EMEA/H/C/426/II/62
Updated with Decision(2015)4853 of 08/07/2015
10/07/2015 Centralised - Yearly update (2015)4853 of 08/07/2015
12/11/2015 Centralised - Notification EMEA/H/C/426/N/75
Updated with Decision(2017)6900 of 09/10/2017
10/11/2016 Centralised - Variation EMEA/H/C/426/II/77
Updated with Decision(2017)6900 of 09/10/2017
11/10/2017 Centralised - Yearly update (2017)6900 of 09/10/2017