Reason for request

Indication extension

Summary of opinion

Favourable opinion for reimbursement in measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (2 to 18 years) in whom active immunisation is contraindicated or not advised.

No clinical added value in the therapeutic strategy. 


Clinical Benefit

Substantial

The clinical benefit of FLEBOGAMMA DIF 50 mg/ml and 100 mg/ml (normal human immunoglobulin) solution for infusion is substantial in measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (2 to 18 years) in whom active immunisation is contraindicated or not advised.


Clinical Added Value

no clinical added value

The medicinal products FLEBOGAMMA DIF 50 mg/ml and 100 mg/ml (normal human immunoglobulin) provide no clinical added value (CAV V) in the management of measles pre-/post exposure prophylaxis for susceptible adults, children and adolescents (2 to 18 years) in whom active immunisation is contraindicated or not advised.


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