HBVaxPro (hepatitis B vaccine (recombinant DNA))
- Region
- 🇪🇺 EU
- Active substance
- hepatitis B vaccine (recombinant DNA)
- Company
- Merck Sharp & Dohme B.V.
- Status
- Authorised
- Therapeutic area
- Hepatitis B; Immunization
- EU approval
- Fri 27 Apr 2001
- Application
- EMEA/H/C/000373
- ATC
- J07BC01
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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