#SFHS2607856ADecree of 26 March 2026 amending the list of pharmaceutical specialties approved for use by public authorities and various public services
AI-generated summary for informational purposes only. Not legal advice. See the original source for the authoritative text.
This French decree extends the approved indications for multiple Aldactone and generic Spironolactone products to include the treatment of hirsutism in adults, either alone or in combination with other drugs. The change applies specifically to the listed presentations of spironolactone 25 mg, 50 mg, and 75 mg tablets manufactured by Pfizer. These products are now reimbursed or approved for this new therapeutic use when prescribed within public health facilities, hospitals, and various public services in France. The update takes effect following publication in the Journal Officiel and modifies the existing positive list of approved pharmaceutical specialties for collective use.
AI-generated summary. May contain errors. Refer to official sources for legal decisions.
Key Changes
- Extension of indication for listed spironolactone products to include treatment of hirsutism in adults (alone or in combination)
- Approval applies to 11 specific CIP-coded presentations of Aldactone and Spironolactone Pfizer 25 mg, 50 mg and 75 mg tablets
- All listed products are in tablet form, some scored, in packs of 30, 90 or 100 tablets
+ 3 more changes with Pro
Obligations
What this law requires
Publish the full text of this decree in the Journal Officiel de la République française
Update the official list of pharmaceutical specialties approved for use by public authorities and public services to include the new indication of hirsutism treatment for the specified Aldactone and Spironolactone products
Authorize reimbursement and coverage for Aldactone 25 mg, 50 mg, and 75 mg tablets (Pfizer) and generic Spironolactone (Pfizer) 25 mg, 50 mg, and 75 mg tablets when prescribed for treatment of hirsutism in adults, either alone or in combination with other medications
Recognize and apply the new therapeutic indication for hirsutism treatment to all nine specific pharmaceutical presentations listed in the Annex, identified by their CIP codes
Implement the decree modifications effective from the date of publication in the Journal Officiel de la République française