Primavax (diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- diphtheria, tetanus and hepatitis B (rDNA) vaccine (adsorbed)
- Company
- Pasteur Mà¨rieux MSD
- Status
- Withdrawn
- Therapeutic area
- Hepatitis B; Tetanus; Immunization; Diphtheria
- EU approval
- Thu 05 Feb 1998
- Application
- EMEA/H/C/000156
- ATC
- J07CA
- Official record
- www.ema.europa.eu
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 boosteraccording to national vaccination policies.This vaccine should not be administered to neonates.This vaccine is not intended for use in adolescents or adults.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Infanrix Hexa Authorised · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Hexacima Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Hexyon Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Vaxelis Authorised · MCM Vaccine B.V.
- 🇪🇺 Tritanrix HepB Lapsed · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Infanrix Penta Lapsed · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Hexavac Withdrawn · Sanofi Pasteur MSD, SNC
- 🇪🇺 Quintanrix Withdrawn · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Infanrix HepB Withdrawn · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Triacelluvax Withdrawn · Chiron S.p.A.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.