Quality & complianceOfficial

ANSM allows pharmacists to substitute Rifinah with two single-agent TB medicines amid supply tensions

🇫🇷 ANSM · Tue 10 Nov 2026

France's medicines agency has issued a temporary recommendation after Sanofi production problems disrupted European supplies of the rifampicin/isoniazid combination, and has capped distribution.

The French medicines agency ANSM has announced an exceptional, temporary measure to protect continuity of tuberculosis treatment after supply tensions on Rifinah (rifampicin/isoniazid). The agency says the tensions, observed at European level, stem from production difficulties at Sanofi. The notice was published on 10 November 2026.

ANSM says Sanofi told it in early October of problems at its production site, which caused delays in Rifinah deliveries. To limit the impact on patients, the agency has introduced capped distribution, intended to spread available stock more evenly across France so that as many patients as possible can be supplied.

In addition, and in consultation with healthcare professional representatives, ANSM has published a recommendation allowing pharmacists to replace Rifinah 300 mg/150 mg coated tablets directly if the product is unavailable. The substitute is a combination of a rifampicin-only medicine (Rifadine 300 mg capsule or Rimactan 300 mg capsule) and an isoniazid-only medicine (Rimifon 150 mg tablet). One Rifinah tablet corresponds to one capsule of Rifadine or Rimactan plus one tablet of Rimifon.

Pharmacists may make the swap without the patient presenting a new prescription, following the conditions set out in the recommendation. They are asked to check strengths and dosing instructions to ensure equivalent treatment, and to explain to patients how to take the two products and confirm they understand. Doctors are advised to prescribe by international non-proprietary name to ease substitution, and to tell patients that replacement with products containing the same active substances is possible without affecting their tuberculosis treatment. Rifinah is indicated for all forms of tuberculosis, including pulmonary disease.

What it means for your team

  • Supply-chain and market-access teams should note the capped distribution in France and the Sanofi production issue behind a shortage described as European in scope.
  • Pharmacy-facing teams should be aware that the substitution is explicitly exceptional and temporary, and tied to Rifinah being unavailable.
  • Prescribing by international non-proprietary name is advised, as it simplifies pharmacist substitution during shortages.
  • Pharmacovigilance and medical information teams may expect queries on dosing and administration of the two-product regimen, since pharmacists are asked to verify strengths and counsel patients.

Official source: ANSM ↗

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

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