Reason for request

Renewal of inclusion

-


Clinical Benefit

Insufficient

The Committee notes that this medicinal product has been refundable by
National Health Insurance since 1963 on the basis solely of pharmacological
data. However, taking into account the lack of any clinical data
demonstrating the efficacy of ethanolamine tenoate on nasal congestion
during acute nasopharyngitis, the actual benefit of RHINOTROPHYL, nasal
spray, solution remains insufficient in the Marketing Authorisation indication
for reimbursement by National Health Insurance.