Vaxelis (diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed))
- Region
- 🇪🇺 EU
- Active substance
- diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
- Company
- MCM Vaccine B.V.
- Status
- Authorised
- Therapeutic area
- Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B
- CHMP opinion
- Thu 17 Dec 2015
- EU approval
- Mon 15 Feb 2016
- Application
- EMEA/H/C/003982
- ATC
- J07CA09
- Official record
- www.ema.europa.eu
Indication
Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.
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
- 🇪🇺 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- 🇪🇺 Hexavac Withdrawn · Sanofi Pasteur MSD, SNC
- 🇪🇺 Quintanrix Withdrawn · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Infanrix HepB Withdrawn · GlaxoSmithKline Biologicals S.A.
- 🇪🇺 Triacelluvax Withdrawn · Chiron S.p.A.
- 🇪🇺 Primavax Withdrawn · Pasteur Mà¨rieux MSD
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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.