Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Primavax
Auth. number : EU/1/97/056
Active substance : diphteria, tetanus and hepatitis B (recombinant) vaccine, adsorbed
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: J07CA07 - diphtheria-hepatitis B-tetanus
(See WHO ATC Index)
Indication: Active immunization against hepatitis B; caused by all known subtypes, diphtheria and tetanus in infants for primary vaccination, for booster according to national vaccination policies
Marketing Authorisation Holder: Aventis Pasteur MSD
8 rue Jonas Salk, 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
10/02/1998 Centralised - Authorisation EMEA/H/C/156 (1998)254 of 05/02/1998
09/06/1998 Centralised - Variation EMEA/H/C/156/I/1 (1998)1498 of 08/06/1998
03/08/2000 Centralised - Withdrawal (2000)2335 of 27/07/2000