PV Bulletin

Modification of List of Health Products by ANSM on 02/09/2026

ANSM decision on modifying the health products list under article L. 5126-6 of the public health code.

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.

PV Impact Brief

Urgency: HighConfidence: high

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.

Action needed

Pharmacovigilance systems must be updated to monitor and report on the newly added medications.

Relevant for
Regulatory Intelligence Lead
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Evidence and confidence

Confidence: highSource updated: Sep 2, 2026

Full briefing

Practical implication

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.

View original source

  • Source: ANSM (France) - News feed
  • Published at source: 2026-09-02T00:00:00.000Z
  • Discovered by monitor: 2026-09-02T21:40:23.165Z

Published from the regulator source ingestion pipeline after PV impact triage.

#Safety Signals#Other#Source-ingestion#Regulator-monitor#Translated From French#France#Ansm.sante.fr

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