This is a summary of the European public assessment report (EPAR) for HBVaxPro. 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 HBVaxPro.
Therapeutic Indication
### Therapeutic indication **5 micrograms** HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals from birth through 15 years of age considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. **10 micrograms** HBVaxPro is indicated for active immunisation against hepatitis-B-virus infection caused by all known subtypes in individuals 16 years of age or more considered at risk of exposure to hepatitis-B virus. The specific at-risk categories to be immunised are to be determined on the basis of the official recommendations. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis-B infection. **40 micrograms** HBVaxPro is indicated for the active immunisation against hepatitis-B-virus infection caused by all known subtypes in predialysis and dialysis adult patients. It can be expected that hepatitis D will also be prevented by immunisation with HBVaxPro as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.
Therapeutic Area (MeSH)
ATC Code
J07BC01
ATC Item
hepatitis B, purified antigen
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| hepatitis B, recombinant surface antigen | N/A | hepatitis b, recombinant surface antigen |
EMA Name
HBVaxPro
Medicine Name
HBVaxPro
Aliases
N/ANo risk management plan link.
