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New HTA Decisions in France
June 2020
Drug name
OZALIN® (midazolam)
Company
Nordic Pharma
Decision date
23/10/2019
Therapeutic area
Multiple Conditions
Therapeutic sub area
Official notice date
18/11/2019
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
No improvement (V)
Indication
OZALIN® is indicated in children 6 months to 17 years of age, for moderate sedation before a therapeutic or diagnostic procedure, or as a premedication before anesthesia.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of OZALIN® to be 'important' in the indications of the Marketing Authorisation. Given: - data from a non-comparative pharmacokinetic study in a small number of patients (n = 37); - the lack of efficacy and tolerance data versus an oral extemporaneous preparation based on HYPNOVEL® IV; it was concluded that OZALIN® does not provide any improvement in the medical service rendered (ASMR V) compared to the reference specialty HYPNOVEL® in the indications of the Marketing Authorisation.