This is a summary of the European public assessment report (EPAR) for Vaxelis. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Vaxelis. For practical information about using Vaxelis, patients should read the package leaflet or contact their doctor or pharmacist.
Therapeutic Indication
### Therapeutic 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.
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 |
|---|---|---|
| Diphtheria toxoid | N/A | 白喉类毒素 |
| tetanus toxoid | N/A | 破伤风类毒素 |
| hepatitis B surface antigen produced in yeast cells | N/A | hepatitis b surface antigen produced in yeast cells |
| poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein. | N/A | inactivated poliovirus vaccine |
| Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3 | N/A | Bordetella pertussis pertactin antigen |
EMA Name
Vaxelis
Medicine Name
Vaxelis
Aliases
N/A
