#SFHS2535352AMinisterial Order of December 22, 2025, Amending the List of Approved Pharmaceutical Specialties for Public Use
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This law adds a new pharmaceutical product to the list of medicines approved for use in public institutions in France. The medicine, Amphotericin B Liposomal Medipha, is approved for specific therapeutic uses including treating certain fungal infections where other treatments fail or are intolerable. This impacts health institutions in terms of procurement and insurance coverage for these uses.
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Key Changes
- Addition of a new pharmaceutical product to the approved list
- Specific therapeutic uses defined for the new product
- Insurance coverage for these uses in public institutions
Obligations
What this law requires
Public health institutions and services must include Amphotericin B Liposomal Medipha (CIP code 34009 551 107 1 2) on their approved pharmaceutical procurement lists
Health insurance (assurance maladie) must provide coverage for Amphotericin B Liposomal Medipha only for the specific therapeutic indications listed in the medicine's market authorization as of the publication date of this order
Coverage is restricted to invasive Aspergillus fungal infections as an alternative therapy only when voriconazole treatment has failed or is intolerable
Coverage for invasive Candida infections is limited to cases of renal impairment (serum creatinine >220 micromol/l or creatinine clearance <25 ml/min) or pre-existing persistent renal dysfunction meeting these same thresholds
Coverage for neuro-meningeal cryptococcosis applies only to HIV-infected patients