This is a summary of the European public assessment report (EPAR) for Hexyon. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Hexyon. For practical information about using Hexyon, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic 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.
Therapeutic Area (MeSH)
ATC Code
J07CA09
ATC Item
diphtheria-haemophilus influenzae B-pertussis-poliomyelitis-tetanus-hepatitis B
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| filamentous haemagglutinin | N/A | Bordetella pertussis filamentous hemagglutinin antigen (formaldehyde inactivated) |
| hepatitis B surface antigen | N/A | 乙型肝炎病毒表面抗原 |
| pertussis toxoid | N/A | Bordetella pertussis toxoid antigen (formaldehyde, glutaraldehyde inactivated) |
| Diphtheria toxoid | N/A | 白喉类毒素 |
| tetanus protein | N/A | Meningococcal Polysaccharide Tetanus Protein Conjugate(Sanofi Pasteur) |
| poliovirus (inactivated) type 2 (MEF-1 strain) produced on Vero cells | N/A | inactivated poliovirus vaccine |
| poliovirus (inactivated) type 3 (Saukett strain) produced on Vero cells | N/A | inactivated poliovirus vaccine |
| Haemophilus influenzae type B polysaccharide (polyribosylribitol phosphate) | N/A | haemophilus influenzae type b |
| poliovirus (inactivated) type 1 (Mahoney strain) produced on Vero cells | N/A | inactivated poliovirus vaccine |
| tetanus toxoid adsorbed on aluminium hydroxide, hydrated | N/A | Adsorbed Tetanus Toxoid(Takeda Pharmaceutical) |
EMA Name
Hexyon
Medicine Name
Hexyon
Aliases
N/ANo risk management plan link.
