RegulatoryOfficial

ANSM lets French pharmacists swap Rifinah for two single-agent TB medicines amid shortage

🇫🇷 ANSM · Tue 10 Nov 2026

France's medicines agency has issued an exceptional, temporary substitution recommendation after Sanofi production problems disrupted European supplies of the fixed-dose rifampicin/isoniazid tablet.

The French medicines agency ANSM has published a temporary recommendation allowing pharmacists to replace Rifinah 300 mg/150 mg coated tablets when the product is unavailable. The notice, dated 10 November 2026, follows supply tensions that the agency says are being observed across Europe.

ANSM attributes the shortage to production difficulties at Sanofi. The company told the agency in early October of problems at its manufacturing site, which have delayed deliveries of Rifinah, a combination of rifampicin 300 mg and isoniazid 150 mg indicated for tuberculosis in all its forms, including pulmonary disease.

Under the recommendation, one Rifinah tablet can be replaced by one capsule of rifampicin alone (Rifadine 300 mg or Rimactan 300 mg) plus one tablet of isoniazid alone (Rimifon 150 mg). Pharmacists may dispense the substitute without the patient presenting a new prescription, following the arrangements set out in the recommendation, which was drawn up in consultation with healthcare professional representatives.

ANSM has also introduced capped distribution to spread available stock more evenly across the country, so that as many patients as possible can be supplied. The agency asks pharmacists to check doses and administration instructions to ensure the treatment remains equivalent, and to explain to patients how to take the two replacement medicines and confirm they understand. Prescribers are advised to write prescriptions using the international non-proprietary name (INN) to ease substitution, and to tell patients that replacement with products containing the same active substances should not affect their TB treatment.

The source does not state how long the measure will last or when normal Rifinah supply is expected to resume. ANSM's separate supply-tension page for Rifinah, first published on 22 March 2024, was last updated on 16 October 2026.

What it means for your team

  • Supply and market-access teams should note the capped distribution in France and the European scope of the Sanofi-related shortage, with no recovery date given.
  • Marketing authorisation holders for Rifadine, Rimactan and Rimifon may face higher demand as pharmacists start dispensing them together in place of Rifinah.
  • Pharmacovigilance and quality teams may wish to watch for dosing or administration errors linked to moving from one fixed-dose tablet to two separate products.
  • Prescribing by INN is now being encouraged to ease substitution at the pharmacy.

Official source: ANSM ↗

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

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