This is a summary of the European public assessment report (EPAR) for Ambirix. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Ambirix.
Therapeutic Indication
### Therapeutic indication Ambirix is for use in non-immune persons from one year up to and including 15 years of age for protection against hepatitis-A and hepatitis-B infection. Protection against hepatitis-B infections may not be obtained until after the second dose. Therefore: - Ambirix should be used only when there is a relatively low risk of hepatitis-B infection during the vaccination course; - it is recommended that Ambirix should be administered in settings where completion of the two-dose vaccination course can be assured.
Therapeutic Area (MeSH)
N/AATC Code
J07BC20
ATC Item
combinations
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
N/AINN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| hepatitis A virus (inactivated) | N/A | 甲肝疫苗 |
| hepatitis B surface antigen | N/A | 乙型肝炎病毒表面抗原 |
EMA Name
Ambirix
Medicine Name
Ambirix
Aliases
N/ANo risk management plan link.
