Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: Hexavac
Auth. number : EU/1/00/147
INN : diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis, hepatitis B (recombinant) and Haemophilus influenzae type b conjugate vaccine, adjuvanted
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: J07CA09 - Diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
(See WHO ATC Index)
Indication: active immunisation against diphtheria, tetanus, pertussis, hepatitis B caused by all known subtypes of viruses, poliomyelitis and invasive infections caused by Haemophilus influenzae type b
Marketing Authorisation Holder: Aventis Pasteur MSD
8 rue Jonas Salk, F-69007 Lyon, France

  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
26/10/2000 Centralised - Authorisation EMEA/H/C/298 (2000)2874 of 23/10/2000
16/07/2001 Centralised - Variation EMEA/H/C/298/I/3
16/07/2001 Centralised - Variation EMEA/H/C/298/I/4
16/07/2001 Centralised - Variation EMEA/H/C/298/I/5
25/10/2001 Centralised - Variation EMEA/H/C/298/II/1 (2001)2896 of 24/10/2001
07/11/2001 Centralised - Variation EMEA/H/C/298/II/6
23/04/2002 Centralised - Variation EMEA/H/C/298/I/11
06/05/2002 Centralised - Variation EMEA/H/C/298/II/10
02/07/2002 Centralised - Variation EMEA/H/C/298/I/8
02/07/2002 Centralised - Variation EMEA/H/C/298/I/7
02/07/2002 Centralised - Variation EMEA/H/C/298/II/9
11/07/2002 Centralised - Variation EMEA/H/C/298/I/12
16/01/2003 Centralised - Variation EMEA/H/C/298/II/13, 14 (2003)306 of 14/01/2003
05/08/2003 Centralised - Variation EMEA/H/C/298/I/15
13/08/2003 Centralised - Variation EMEA/H/C/298/I/16
03/02/2004 Centralised - Variation EMEA/H/C/298/II/17 (2004)297 of 29/01/2004
15/07/2004 Centralised - Variation EMEA/H/C/298/IA/18
09/08/2004 Centralised - Variation EMEA/H/C/298/N/20
Updated with Decision(2005)3614 of 19/09/2005
28/10/2004 Centralised - Variation EMEA/H/C/298/II/19
24/02/2005 Centralised - Variation EMEA/H/C/298/II/2
30/03/2005 Centralised - Variation EMEA/H/C/298/IA/23
Updated with Decision(2005)3614 of 19/09/2005
26/04/2005 Centralised - Variation EMEA/H/C/298/IA/25
Updated with Decision(2005)3614 of 19/09/2005
28/04/2005 Centralised - Variation EMEA/H/C/298/II/22
05/08/2005 Centralised - Variation EMEA/H/C/298/II/26
05/08/2005 Centralised - Variation EMEA/H/C/298/II/24
21/09/2005 Referral EMEA/H/C/298/A-18/655rev (2005)3614 of 19/09/2005
21/11/2005 Referral EMEA/H/C/298/Z/28 (2005)4544 of 17/11/2005
04/07/2012 Centralised - Withdrawal (2012)4591 of 28/06/2012