Primavax
Withdrawn
This medicine's authorisation has been withdrawn
diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed)
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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.
Product information
27/07/2000
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Primavax
- Active substance
- Diphtheria toxoid
- hepatitis B, recombinant surface antigen
- tetanus toxoid
- International non-proprietary name (INN) or common name
- diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed)
- Therapeutic area (MeSH)
- Hepatitis B
- Tetanus
- Immunization
- Diphtheria
- Anatomical therapeutic chemical (ATC) code
- J07CA
Pharmacotherapeutic group
VaccinesTherapeutic 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.
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