PharmacovigilanceOfficial

ANSM reinstates compounded quetiapine substitution as 50 mg prolonged-release supply tightens again

🇫🇷 ANSM · Thu 22 Oct 2026

France's medicines agency has reactivated a temporary substitution framework and asked doctors not to start new patients on quetiapine PR 50 mg, citing manufacturing delays at Pharmathen in Greece.

ANSM has announced management measures for renewed supply tensions affecting quetiapine prolonged-release (PR) 50 mg in France. Manufacturing delays have hit availability since mid-October 2026, and the agency says it does not yet know when supply will return to normal. Cover for the 300 mg and 400 mg prolonged-release strengths is described as secure.

The agency links the problem to persistent manufacturing delays at the Greek site of Pharmathen. It says the situation is now worse because other manufacturers cannot make up the shortfall. New deliveries are expected in the coming weeks but will not fully meet demand for the 50 mg strength.

To protect continuity of treatment, ANSM is bringing back its framework for compounded immediate-release (IR) quetiapine, on the same terms as in earlier shortages. From 15 October 2026, if a 50 mg prolonged-release product is unavailable, a pharmacist may exceptionally and temporarily replace it with a compounded IR preparation at 50 mg, 100 mg or 150 mg. No new prescription is needed. ANSM has published a replacement recommendation dated 22 October 2026.

Pharmacists are reminded to follow an equivalence table. It maps one to five 50 mg prolonged-release tablets taken once daily to IR capsules of 50 mg, 100 mg or 150 mg, or combinations, taken in the evening at bedtime. ANSM adds that some patients may need the dose split into morning and evening, and that the IR form is not necessarily taken in the same way as the prolonged-release form.

For prescribers, ANSM asks doctors not to start new treatment with quetiapine PR 50 mg where a suitable alternative exists, except for a major depressive episode in bipolar disorder. For existing patients, it asks doctors to adapt management where possible, including through alternative treatments; the source text is cut off before the remaining detail. The agency has asked Pharmathen to speed up supply and asked marketing-authorisation holders to look for imports of equivalent medicines.

What it means for your team

  • Supply-chain and market-access teams should treat the 50 mg PR shortage as open-ended: ANSM gives no recovery date and says incoming volumes will fall short of demand.
  • Marketing-authorisation holders have been asked by ANSM to explore imports of equivalent products, which may require contingency planning and engagement with the agency.
  • Pharmacovigilance and quality teams may want to monitor for medication errors or tolerability issues linked to IR substitution, given ANSM's note that dosing patterns can differ from the PR form.
  • Medical affairs and customer-facing teams should be ready for queries on the new-initiation restriction and its bipolar depression exception.

Official source: ANSM ↗

Article written by VigiEye from the official source (ANSM). AI-assisted; check the source before acting.

More Pharmacovigilance All →