Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Infanrix HepB
Auth. number : EU/1/97/048
INN : Diphteria, tetanus, acellular pertussis and 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 of infants
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
01/08/1997 Centralised - Authorisation EMEA/H/C/126 (97)2703 of 30/07/1997
05/11/1998 Centralised - Notification EMEA/H/C/126/N/1 (1998)3390 of 29/10/1998
02/08/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/II/10
22/03/2001 Centralised - Variation EMEA/H/C/126/II/11 (2001)609 of 20/03/2001
11/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/I/14
22/05/2001 Centralised - Notification EMEA/H/C/126/N/12 (2001)1240 of 18/05/2001
24/09/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/II/13
02/10/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/II/15
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/I/20
28/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/I/16
19/12/2001 Centralised - Variation EMEA/H/C/126/I/17 (2001)4205 of 17/12/2001
08/02/2002 Centralised - Variation EMEA/H/C/126/I/18, 19 (2002)497 of 06/02/2002
27/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/I/22
17/01/2003 Centralised - Renewal EMEA/H/C/126/R/21 (2003)321 of 15/01/2003
10/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/II/23
18/09/2003 Centralised - Notification EMEA/H/C/126/N/27 (2003)3343 of 16/09/2003
03/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/I/26
24/11/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/II/25
17/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/126/IA/28
27/04/2005 Centralised - Withdrawal (2005)1343 of 25/04/2005