#SFHS2612392AFrance adds ADAFLEX melatonin tablets to reimbursable medicines list
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
ADAFLEX melatonin tablets in six strengths, from 0.5 mg to 5 mg, will be reimbursable by French health insurance for a specific use: insomnia in children and adolescents aged 6 to 17 with ADHD, when sleep hygiene measures have not worked. The change mainly affects prescribers, pharmacies, patients, families, and the manufacturer H.A.C. Pharma. Reimbursement applies only to the listed therapeutic indication and takes effect four days after publication in the French Official Journal.
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Key Changes
- Adds six ADAFLEX melatonin tablet presentations to the list of medicines reimbursable by French health insurance
- Limits reimbursement to insomnia in children and adolescents aged 6 to 17 with ADHD when sleep hygiene measures have been insufficient
- Sets the effective date as the fourth day after publication in the French Official Journal
Obligations
What this law requires
French health insurance reimbursement for ADAFLEX melatonin tablets must be limited to treatment of insomnia in children and adolescents aged 6 to 17 with ADHD where sleep hygiene measures have been insufficient.
The listed ADAFLEX melatonin presentations of 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg, and 5 mg tablets supplied in B/30 HDPE child-safety bottles by H.A.C. Pharma must be treated as reimbursable medicines only under the indication specified in the annex.