Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1208933
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Name of medicinal product:
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AMBIRIX
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Active substances:
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ATC code:
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J07BC80
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Dosage form:
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suspension for injection
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Route of administration:
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intramuscular use
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Strengh:
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1annus+1annus 1ml
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Amount in package:
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1ml 10TK
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Legal status for supply*:
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Subject to medicinal prescription
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Class of active substance:
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|
Additional information:
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Indication:
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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).
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.
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Safety features:
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Yes
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Summary of product characteristics (SPC):
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|
Package information leaflet (PIL):
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EST
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Labelling:
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Last imported to Estonia:
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Never imported to Estonia
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Marketing authorization holder:
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Glaxosmithkline Biologicals
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Marketing authorization number:
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EU/1/02/224
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Marketing authorization issued on:
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August 30, 2002
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Marketing authorization expires on:
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Unlimited
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Marketing authorization procedure type:
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Centralised
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Reference price:
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|
Under reference price:
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|
Reference price of daily dose:
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Description
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Additional condition
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Ei ole lubatud väljastada korduvretsepti
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Entry/Changing date:
June 15, 2023
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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