HUMAN HEPATITIS B IMMUNOGLOBULIN LFB
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Opinions on drugs -
Posted on
Apr 25 2013
Reason for request
Inclusion
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Clinical Benefit
Substantial |
The actual benefit of HUMAN HEPATITIS B IMMUNOGLOBULIN LFB in the Marketing Authorisation indications is substantial. |
Clinical Added Value
important |
HUMAN HEPATITIS B IMMUNOGLOBULIN LFB provides a high level of improvement in actual benefit (level II) in hepatitis B immunoprophylaxis : - in accidental exposure in non-immunised people (including when vaccination is incomplete or unknown) ; - in haemodialysis patients pending vaccination being effective ; - in newborn babies of mothers carrying the hepatitis B virus ; - in patients who have not developed an immune response after vaccination against the hepatitis B virus (undetectable antibodies against hepatitis B) and who require continued protection against this disease. |
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