4.1 Therapeutic indications
Ambirix is indicated in non-immune children and adolescents from 1 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 (see section 5.1).
- 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.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).