On 5 February 1998, the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Primavax, which is a combined trivalent vaccine. The pharmaceutical company responsible for this medicinal product is Aventis Pasteur MSD S.N.C. On 18 May 2000, the Marketing Authorisation holder notified the European Commission about the Marketing Authorisation holder’s decision to withdraw the Marketing Authorisation for Primavax. On 27 July 2000, the European Commission adopted the decision, withdrawing the Marketing Authorisation for the medicinal product for human use “Primavax \- Diphtheria, Tetanus and Hepatitis B vaccine” EU/1/97/056/001\. Pursuant to this decision the European Public Assessment Report for Primavax has been removed from this website.
Therapeutic Indication
This vaccine is indicated for 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. This vaccine should not be administered to neonates. This vaccine is not intended for use in adolescents or adults.
Therapeutic Area (MeSH)
ATC Code
J07CA
ATC Item
N/A
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
EMA Name
Primavax
Medicine Name
Primavax
Aliases
N/ANo risk management plan link.