Health

#SFHS2608108ADecree of 30 March 2026 on the delisting of pharmaceutical specialties from the list of medicines approved for public authorities under Article L. 5123-2 of the Public Health Code

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

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

🇬🇧 English

This French decree removes two long-acting injectable risperidone products (OKEDI 100 mg and OKEDI 75 mg) manufactured by Laboratoires ROVI from the official list of medicines approved for use by public authorities and various public services. The delisting takes effect four days after the decree's publication in the Journal officiel. These products are powder and solvent for prolonged-release injectable suspension in pre-filled syringes. After the effective date, these specific presentations can no longer be purchased or reimbursed under the public collective-use medicines framework governed by Article L. 5123-2 of the Public Health Code.

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

Key Changes

  • Two OKEDI risperidone presentations (100 mg and 75 mg prolonged-release injectables) are removed from the approved public authority medicines list
  • Delisting takes effect on the 4th day following publication in the Journal officiel
  • Radiation applies to codes CIP 34009 302 487 5 and 34009 302 487 4

+ 2 more changes with Pro

Obligations

What this law requires

high

Remove OKEDI 100 mg (risperidone) powder and solvent for prolonged-release injectable suspension (CIP code 34009 302 487 5 1) from the official list of medicines approved for public authorities and public services

Public health authorities managing the approved medicines list under Article L. 5123-2
operational
high

Remove OKEDI 75 mg (risperidone) powder and solvent for prolonged-release injectable suspension (CIP code 34009 302 487 4 4) from the official list of medicines approved for public authorities and public services

Public health authorities managing the approved medicines list under Article L. 5123-2
operational
high

Cease purchasing of OKEDI 100 mg and OKEDI 75 mg products under the public collective-use medicines framework effective four days after publication in the Journal officiel

Public authorities and public services purchasing medicines under Article L. 5123-2
prohibition
high

Cease reimbursement of OKEDI 100 mg and OKEDI 75 mg products under the public collective-use medicines framework effective four days after publication in the Journal officiel

Public authorities and reimbursement bodies administering the collective-use medicines framework
prohibition
high

Publish this decree in the Journal officiel de la République française

Issuing government authority
disclosure

Affected Parties

Laboratoires ROVIFrench public hospitals and healthcare facilities+3 more…

Tags

pharmaceutical regulation,drug delisting,risperidone