Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Twinrix Paediatric   

   This product is authorized under a different brandname in the EU in the folowing languages:
   - Twinrix Pædiatrisk (DA)
   - Twinrix Kinder (DE)
   - Twinrix Παιδιατρικό (EL)
   - Twinrix Pediátrico (ES)
   - Twinrix Junior (ET)
   - Twinrix Enfant (FR)
   - Twinrix Gyermek (HU)
   - Twinrix Pediatrico (IT)
   - Twinrix Junior (PL)
   - Twinrix Pediátrico (PT)
   - Twinrix Pediatric (RO)
   - Twinrix za otroke (SL)
Auth. number : EU/1/97/029
INN : 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 infants, children and adolescents from 1 year up to and including 15 years 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
11/02/1997 Centralised - Authorisation EMEA/H/C/129 (97)344 of 10/02/1997
20/11/1997 Centralised - Variation EMEA/H/C/129/II/2 (97)3574 of 19/11/1997
08/01/1999 Centralised - Notification EMEA/H/C/129/N/6 (1998)4522 of 22/12/1998
28/01/1999 Centralised - Variation EMEA/H/C/129/I/5 (1999)159 of 26/01/1999
27/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/13
11/10/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/I/14
08/03/2001 Centralised - Variation EMEA/H/C/129/I/18 (2001)311 of 05/03/2001
23/03/2001 Centralised - Variation EMEA/H/C/129/II/15 (2001)611 of 20/03/2001
17/05/2001 Centralised - Notification EMEA/H/C/129/N/17 (2001)914 of 03/05/2001
31/08/2001 Centralised - Variation EMEA/H/C/129/II/20 (2001)2133 of 30/08/2001
02/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/19
14/11/2001 Centralised - Renewal EMEA/H/C/129/R/21 (2001)3520 of 09/11/2001
27/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/I/22
27/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/I/26
20/12/2001 Centralised - Variation EMEA/H/C/129/I/23 (2001)4345 of 18/12/2001
08/02/2002 Centralised - Variation EMEA/H/C/129/I/24, 25 (2002)496 of 06/02/2002
03/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/28
15/04/2002 Centralised - Variation EMEA/H/C/129/II/27 (2002)1443 of 11/04/2002
27/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/I/32
29/10/2002 Centralised - Variation EMEA/H/C/129/II/29 (2002)4298 of 24/10/2002
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/33
23/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/I/38
03/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/34
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/35
27/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/36
17/12/2003 Centralised - Notification EMEA/H/C/129/N/39 (2003)5057 of 15/12/2003
17/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IA/40
17/08/2004 Centralised - Notification EMEA/H/C/129/N/41
Updated with Decision(2006)3921 of 28/08/2006
03/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IA/44
15/09/2005 Centralised - Notification EMEA/H/C/129/N/45
Updated with Decision(2006)3921 of 28/08/2006
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/43
03/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/42
31/08/2006 Centralised - Renewal EMEA/H/C/129/R/46 (2006)3921 of 28/08/2006
22/11/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/48
09/01/2007 Centralised - Variation EMEA/H/C/129/II/47 (2007)21 of 04/01/2007
07/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IA/51
24/01/2008 Centralised - Variation EMEA/H/C/129/II/49 (2008)334 of 22/01/2008
18/02/2008 Corrigendum EMEA/H/C/129/II/49
07/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IA/52
23/06/2008 Centralised - Variation EMEA/H/C/129/II/50 (2008)3083 of 19/06/2008
07/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IA/53
05/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IA/54
19/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IB/56
06/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/55
23/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IB/57
21/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IB/58
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/59
07/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/60
17/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/WS/1
08/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/61
09/11/2010 Centralised - Variation EMEA/H/C/129/II/63, 64 (2010)7829 of 05/11/2010
06/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/II/62
18/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IG/52/G
29/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/129/IG/51/G
17/01/2012 Centralised - Variation EMEA/H/C/129/WS/153, EMEA/H/C/129/II/65 (2012)186 of 13/01/2012
27/11/2013 Centralised - Notification EMEA/H/C/129/N/85