Health

#SFHS2612394AFrance adds ADAFLEX melatonin tablets to the approved public-sector medicines list

🇫🇷France··Other·Low Impact·View source ↗

AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.

🇬🇧 English

This order adds six ADAFLEX melatonin tablet presentations, from 0.5 mg to 5 mg, to France’s list of medicines approved for use by public institutions and public services. Health insurance coverage is limited to one use: insomnia in children and adolescents aged 6 to 17 with ADHD, when sleep hygiene measures have not worked. Hospitals, public healthcare buyers, prescribers, and pharmacies should apply this coverage limit when using or supplying these products.

AI-generated summary. May contain errors. Refer to official sources for legal decisions.

Key Changes

  • Adds six ADAFLEX melatonin tablet presentations to the approved list for public-sector use
  • Covers strengths from 0.5 mg to 5 mg in 30-tablet child-resistant bottles
  • Limits health insurance coverage to insomnia in children and adolescents aged 6 to 17 with ADHD after failed sleep hygiene measures

Obligations

What this law requires

medium

Public institutions and public services may use or procure the six listed ADAFLEX melatonin tablet presentations only as specialties approved on the official collectivités/public-services list, as modified by the annex to this order.

public healthcare institutionspublic services procuring medicineshospital pharmacies
Upon publication in the Journal officiel de la République française
licensing
high

Health insurance reimbursement for the listed ADAFLEX melatonin presentations must be limited to insomnia in children and adolescents aged 6 to 17 with ADHD where sleep hygiene measures have been insufficient.

health insurance bodiespublic healthcare institutionsprescriberspharmacies
operational

Affected Parties

Public hospitals and healthcare institutionsPublic-sector medicine purchasers+3 more…

Tags

pharmaceuticals,melatonin,ADHD…