Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Twinrix Adult   

   This product is authorised under a different brandname in the EU in the folowing languages:
   - Twinrix Voksen (DA)
   - Twinrix Erwachsene (DE)
   - Twinrix για Ενήλικες (EL)
   - Twinrix Adultos (ES)
   - Twinrix Adulte (FR)
   - Twinrix Felnőtt (HU)
   - Twinrix Adulti (IT)
   - Twinrix Adulto (PT)
   - Twinrix za odrasle (SL)
   - Twinrix Vuxen (SV)
Auth. number : EU/1/96/020
Active substance : Hepatitis A and hepatitis B vaccine
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: Indicated for use in non immune adults and adolescents 16 years of age and above who are at risk of both hepatitis A and hepatitis B infection.
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
23/09/1996 Centralised - Authorisation EMEA/H/C/112 (96)2573 of 20/09/1996
16/09/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/1
07/11/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/4
07/11/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/3
18/11/1997 Centralised - Variation EMEA/H/C/112/II/2 (97)3559 of 17/11/1997
08/01/1999 Centralised - Notification EMEA/H/C/112/N/6 (1998)4523 of 22/12/1998
14/01/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/7
28/01/1999 Centralised - Variation EMEA/H/C/112/I/5 (1999)151 of 26/01/1999
18/05/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/8
09/07/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/9
14/09/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/11
14/09/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/10
29/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/12
27/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/13
11/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/14
30/01/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/16
22/03/2001 Centralised - Variation EMEA/H/C/112/II/15 (2001)574 of 20/03/2001
18/05/2001 Centralised - Notification EMEA/H/C/112/N/17 (2001)1236 of 17/05/2001
21/09/2001 Centralised - Variation EMEA/H/C/112/II/19 (2001)2132 of 30/08/2001
02/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/18
12/11/2001 Centralised - Renewal EMEA/H/C/112/R/20 (2001)3516 of 09/11/2001
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/23
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/21
19/12/2001 Centralised - Variation EMEA/H/C/112/I/22 (2001)4203 of 17/12/2001
03/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/25
15/04/2002 Centralised - Variation EMEA/H/C/112/II/24 (2002)1444 of 11/04/2002
02/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/27-28
27/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/29
29/10/2002 Centralised - Variation EMEA/H/C/112/II/26 (2002)4293 of 24/10/2002
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/30
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/I/35
03/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/31
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/33
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/32
03/02/2004 Centralised - Variation EMEA/H/C/112/II/36 (2004)301 of 30/01/2004
17/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IA/37
17/08/2004 Centralised - Notification EMEA/H/C/112/N/38
Updated with Decision(2006)3923 of 28/08/2006
03/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IA/41
15/09/2005 Centralised - Notification EMEA/H/C/112/N/42
Updated with Decision(2006)3923 of 28/08/2006
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/40
03/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/39
31/08/2006 Centralised - Renewal EMEA/H/C/112/R/43 (2006)3923 of 28/08/2006
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/45
09/01/2007 Centralised - Variation EMEA/H/C/112/II/44 (2007)27 of 04/01/2007
26/07/2007 Centralised - Variation EMEA/H/C/112/II/46 (2007)3663 of 24/07/2007
07/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IA/49
21/01/2008 Centralised - Variation EMEA/H/C/112/II/47 (2008)294 of 17/01/2008
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IA/51
23/06/2008 Centralised - Variation EMEA/H/C/112/II/48, 50 (2008)3084 of 19/06/2008
30/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IA/52
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IA/53
19/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IB/55
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/54
23/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IB/56
21/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IB/57
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/58
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/59
17/03/2010 Centralised - Variation EMEA/H/C/112/II/60 (2010)1777 of 15/03/2010
17/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/WS/1
08/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/61
06/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/II/62
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IG/52/G
29/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/112/IG/51/G
27/06/2011 Centralised - Variation EMEA/H/C/112/II/63 (2011)4623 of 23/06/2011
17/01/2012 Centralised - Variation EMEA/H/C/112/II/64, EMEA/H/C/112/WS/153 (2012)187 of 13/01/2012
11/01/2014 Centralised - Notification EMEA/H/C/112/N/84
Updated with Decision(2015)8813 of 02/12/2015
14/01/2015 Centralised - Variation EMEA/H/C/112/IB/103
Updated with Decision(2015)8813 of 02/12/2015
12/11/2015 Centralised - Notification EMEA/H/C/112/N/108
Updated with Decision(2015)8813 of 02/12/2015
04/12/2015 Centralised - Yearly update (2015)8813 of 02/12/2015