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Hexyon (diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed))

Region

🇪🇺 EU

Active substance

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)

Company

Sanofi Winthrop Industrie

Status

Authorised

Therapeutic area

Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria

CHMP opinion

Thu 21 Feb 2013

EU approval

Wed 17 Apr 2013

Application

EMEA/H/C/002796

ATC

J07CA09

Official record

www.ema.europa.eu

Indication

Hexyon (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of this vaccine 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
• 🇪🇺 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• 🇪🇺 Hexavac Withdrawn · Sanofi Pasteur MSD, SNC
• 🇪🇺 Quintanrix Withdrawn · GlaxoSmithKline Biologicals S.A.
• 🇪🇺 Infanrix HepB Withdrawn · GlaxoSmithKline Biologicals S.A.
• 🇪🇺 Triacelluvax Withdrawn · Chiron S.p.A.
• 🇪🇺 Primavax Withdrawn · Pasteur Mà¨rieux MSD

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.