Reason for request

Inclusion

-


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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