Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


EXPIRED  

Product information

Invented name: Tritanrix HepB
Auth. number : EU/1/96/014
Active substance : DTPW-Hepatitis B
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J07 - Vaccines
Pharmacological subgroup: J07C - Bacterial and viral vaccines, combined
Chemical subgroup: J07CA - Bacterial and viral vaccines, combined
Chemical substance: J07CA05 - Diphtheria-hepatitis B-pertussis-tetanus
(See WHO ATC Index)
Indication: Active immunisation against diphtheria, tetanus, pertussis and hepatitis B (HBV) in infants from 6 weeks 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
19/07/1996 Centralised - Authorisation EMEA/H/C/93 (96)1991 of 19/07/1996
26/09/1997 Centralised - Variation EMEA/H/C/93/I/1 (97)2893 of 25/09/1997
31/10/1997 Centralised - Variation EMEA/H/C/93/I/2 (97)3330 of 30/10/1997
10/11/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/3
14/10/1998 Centralised - Notification EMEA/H/C/93/N/1 (1998)3099 of 09/10/1998
30/06/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/5
03/08/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/7
03/08/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/6
29/03/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/8
01/02/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/11
14/03/2001 Centralised - Variation EMEA/H/C/93/II/9 (2001)319 of 13/03/2001
07/05/2001 Centralised - Variation EMEA/H/C/93/II/10 (2001)912 of 03/05/2001
18/05/2001 Centralised - Notification EMEA/H/C/93/N/12 (2001)1237 of 17/05/2001
07/09/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/13
07/09/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/16
08/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/15
23/11/2001 Centralised - Renewal EMEA/H/C/93/R/14 (2001)3592 of 21/11/2001
06/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/17
31/01/2002 Centralised - Variation EMEA/H/C/93/I/18 (2002)398 of 29/01/2002
26/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/19
14/10/2002 Centralised - Notification EMEA/H/C/93/N/25 (2002)3940 of 10/10/2002
04/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/21
25/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/I/27
07/10/2003 Centralised - Notification EMEA/H/C/93/N/28 (2003)3611 of 03/10/2003
16/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IA/30
21/06/2004 Centralised - Variation EMEA/H/C/93/II/29 (2004)2243 of 17/06/2004
22/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/31
02/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IB/32
23/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/34
23/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/35
12/09/2005 Centralised - Notification EMEA/H/C/93/N/38
Updated with Decision(2006)3559 of 28/07/2006
26/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/36
16/11/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IB/37
03/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/33
03/08/2006 Centralised - Renewal EMEA/H/C/93/R/39 (2006)3559 of 28/07/2006
27/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/40
14/08/2007 Centralised - Variation EMEA/H/C/93/II/42 (2007)3934 of 10/08/2007
25/10/2007 Centralised - Variation EMEA/H/C/93/II/41 (2007)5273 of 23/10/2007
10/12/2007 Centralised - Variation EMEA/H/C/93/II/43 (2007)6270 of 06/12/2007
24/04/2008 Centralised - Variation EMEA/H/C/93/II/44 (2008)1685 of 22/04/2008
08/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IA/45
21/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IA/46
18/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IA/51
21/11/2008 Centralised - Variation EMEA/H/C/93/IA/50
Updated with Decision(2009)594 of 27/01/2009
26/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/47
29/01/2009 Centralised - Variation EMEA/H/C/93/II/49 (2009)594 of 27/01/2009
02/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/55
21/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IB/56
22/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/WS/1
11/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IB/58
11/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IB/59
26/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/II/57
23/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/93/IG/52/G
20/09/2012 Centralised - Variation (rejected) EMEA/H/C/93/II/61
01/01/2014 Centralised - Withdrawal