FLUCELVAX (surface antigen, inactivated, prepared in cell cultures) - In the prophylaxis of influenza influenza in adults and children from 6 months

Opinions on drugs - Posted on Jan 29 2026

Reason for request

Modification of the listing conditions

Summary of opinion

Favourable opinion for reimbursement in the prophylaxis of influenza in adults and children from 6 months of age and in accordance with the current vaccination recommendations (HAS opinion of 4 December 2025).

Clinical Benefit

Substantial

The clinical benefit of FLUCELVAX is substantial in the MA indication extension to children from 6 months of age.

Clinical Added Value

no clinical added value

The paediatric indication extension to children from 6 months of age is not of a nature to modify the clinical added value (CAV V) compared to the previous opinion (opinion of 12/02/2025).