Reason for request

Inclusion on list of products reimbursed by National Health Insurance and approved for hospital use for the extension of the indication to cover "Maintenance treatment of moderate to severe atopic dermatitis for the prevention of flares and the prolongation of flare-free intervals in patients experiencing a high frequency of disease exacerbations (i.e. occurring four or more times per year) who have had an initial response to a maximum of 6 weeks treatment of twice daily tacrolimus ointment (lesions cleared, almost cleared or mildly affected)". And Examination of the results of the post-marketing study performed at the request of the transparency Committee.

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Clinical Benefit

Insufficient

The actual benefit of PROTOPIC 0.03 % in children and adults, and by PROTOPIC 0.1 % in adults, is insufficient in the extension of the indication for maintenance treatment of atopic dermatitis, as stated by Marketing Authorisation, to justify reimbursed reimbursement by public funds.


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