Infanrix Hexa (diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type-b (Hib) conjugate vaccine (adsorbed)
- Company
- GlaxoSmithKline Biologicals S.A.
- Status
- Authorised
- Therapeutic area
- Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
- CHMP opinion
- Thu 29 Jun 2000
- EU approval
- Mon 23 Oct 2000
- Application
- EMEA/H/C/000296
- ATC
- J07CA09
- Official record
- www.ema.europa.eu
Indication
Infanrix hexa is indicated for primary and booster vaccination of infants from the age of 6 weeks and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Haemophilus influenzae type b. The use of Infanrix hexa should be in accordance with official recommendations.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tritanrix HepB Lapsed · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Infanrix Penta Lapsed · GlaxoSmithKline Biologicals S.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.