Primary source: ANSM (France) - News feed
Translated From French
PV Bulletin does not take any responsibility for translation errors or omissions, though it has used the best available translation engine.
New medications were added to the regulated list including Fluconazole Noridem, Linezolide Demo, Teicoplanine, Vancomycine, Posaconazole (ELC and Olpha), and Azacitidine (Reddy Pharma).
This modification may influence compliance requirements for pharmacovigilance and reporting practices.
Pharmacovigilance systems must be updated to monitor and report on the newly added medications.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Pharmacovigilance systems must be updated to monitor and report on the newly added medications.
The ANSM has modified the list of health products stating the inclusion of new medications on 02/09/2026, which includes several antibiotics, antifungals, and anticancer medications.
What changed: New medications were added to the regulated list including Fluconazole Noridem, Linezolide Demo, Teicoplanine, Vancomycine, Posaconazole (ELC and Olpha), and Azacitidine (Reddy Pharma).
Why it matters: This modification may influence compliance requirements for pharmacovigilance and reporting practices.
Practical implication: Pharmacovigilance systems must be updated to monitor and report on the newly added medications.
Published from the regulator source ingestion pipeline after PV impact triage.
Focus on therapeutic equivalence evaluations for generics
Affected healthcare facilities and distributors must immediately check their stock, remove BD ChloraPrep applicators from all kits, apply over-labels indicating the need for component removal, and notify any customers if they have transferred or resold these products.
Affected users must identify, segregate, and quarantine the kits, add warning labels, and ensure the removal of the recalled components prior to use.
Companies must ensure compliance with the Irish language requirements and complete mandatory OMS registration before regulatory submissions to prevent delays.
