Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


NOT RENEWED  

Product information

Invented name: Procomvax
Auth. number : EU/1/99/104
INN : Haemophilus b conjugate (Meningococcal Protein conjugate) and Hepatitis B vaccine
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: J07CA08 - Hemophilus influenzae B and hepatitis B
(See WHO ATC Index)
Indication: Procomvax is indicated for vaccination against invasive disease caused by Haemophilus influenza type B and against infection caused by all known sybtypes of hepatitis B virus in infants 6 weeks to 15 months of age
Marketing Authorisation Holder: Sanofi Pasteur MSD, SNC
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
14/05/1999 Centralised - Authorisation EMEA/H/C/231 (1999)1257 of 07/05/1999
03/08/1999 Centralised - Variation EMEA/H/C/231/II/1
03/08/1999 Centralised - Variation EMEA/H/C/231/II/2
04/10/1999 Centralised - Variation EMEA/H/C/231/I/3 (1999)3121 of 30/09/1999
27/03/2000 Centralised - Variation EMEA/H/C/231/N/6 (2000)763 of 20/03/2000
04/05/2000 Centralised - Variation EMEA/H/C/231/I/5
20/07/2000 Centralised - Variation EMEA/H/C/231/I/8 (2000)1795 of 11/07/2000
14/11/2000 Centralised - Variation EMEA/H/C/231/II/7
14/11/2000 Centralised - Variation EMEA/H/C/231/II/9
21/06/2001 Centralised - Variation EMEA/H/C/231/II/10
14/08/2001 Centralised - Variation EMEA/H/C/231/N/12 (2001)2115 of 13/08/2001
07/09/2001 Centralised - Variation EMEA/H/C/231/II/11
14/10/2002 Centralised - Variation EMEA/H/C/231/N/13 (2002)3926 of 10/10/2002
09/01/2003 Centralised - Variation EMEA/H/C/231/II/13
02/10/2003 Centralised - Variation EMEA/H/C/231/II/14
02/08/2004 Centralised - Variation EMEA/H/C/231/II/16
04/08/2004 Centralised - Renewal EMEA/H/C/231/R/15 (2004)3048 of 02/08/2004
23/02/2005 Centralised - Variation EMEA/H/C/231/II/17
15/03/2005 Centralised - Variation EMEA/H/C/231/IA/18
Updated with Decision(2005)4086 of 13/10/2005
22/09/2005 Centralised - Variation EMEA/H/C/231/II/19
18/10/2005 Centralised - Variation (2005)4086 of 13/10/2005
03/07/2006 Centralised - Variation EMEA/H/C/231/IA/21
02/08/2006 Referral EMEA/H/C/231/A-20 (2006)3560 of 28/07/2006
04/08/2006 Centralised - Variation EMEA/H/C/231/IB/22
31/08/2006 Centralised - Variation EMEA/H/C/231/IB/23
22/02/2007 Centralised - Variation EMEA/H/C/231/IA/25
12/09/2007 Centralised - Variation EMEA/H/C/231/N/26
Updated with Decision(2007)6417 of 11/12/2007
13/12/2007 Centralised - Variation EMEA/H/C/231/II/28 (2007)6417 of 11/12/2007
30/01/2008 Centralised - Variation EMEA/H/C/231/I/27
14/05/2009 Centralised - Withdrawal