France's Agence nationale de sécurité du médicament (ANSM) has triggered the recall of all lots of Tavneos 10 mg, gélule (avacopan) still available on French territory from August 19, 2026, after the European Commission withdrew the medicine's Union marketing authorisation on August 4, 2026. From that date, Tavneos can no longer be prescribed or dispensed in France. Vifor Fresenius Medical Care Renal Pharma France, the marketing authorisation holder, is operating the lot recall under ANSM oversight.
The withdrawal closes a seven-month safety sequence. The European Medicines Agency (EMA) opened a review of avacopan on January 30, 2026, after a reassessment of the clinical study underpinning the authorisation concluded that the data no longer demonstrated sufficient benefit to offset known serious hepatic risks. The CHMP recommended revocation on June 26, 2026, the ANSM wrote to concerned healthcare professionals on July 16, 2026, and the Commission executed the revocation through an Implementing Decision of August 4, 2026 recorded in the Community Register. Tavneos had been authorised centrally since January 11, 2022 for adults with certain rare inflammatory diseases of the blood vessels (ANCA-associated vasculitis); about 600 patients were treated with it in France.
What must French pharmacists do from August 19, 2026?
City and hospital pharmacists must not dispense Tavneos under any circumstance from August 19, 2026. If a patient already on treatment presents for a renewal, the pharmacist must not dispense and must contact the prescriber immediately; if a patient arrives with a new initiation prescription, the pharmacist must refuse dispensing and direct the patient back to the prescriber for an alternative. Patients still on Tavneos must be contacted proactively and told to consult their prescriber without delay, and never to stop the treatment on their own initiative. The lot recall and distribution modalities set by Vifor France specify how wholesalers-répartiteurs and pharmacies must return affected stock.
What must prescribers do for patients still on Tavneos?
Prescribers must not initiate any new Tavneos treatment and must not renew existing ones. For the about 600 patients still exposed, the priority is a controlled switch: contact each patient as soon as possible to organise a transition to a suitable alternative therapeutic option. Abrupt cessation of avacopan without a relay treatment must be avoided because it can aggravate the underlying vasculitis. Hepatic surveillance of patients transitioning off Tavneos should be reinforced, consistent with the ANSM letter of July 16, 2026, which anticipated the withdrawal and asked prescribers to stop initiating, redirect patients, and step up liver monitoring.
Why was the EU marketing authorisation withdrawn?
The Commission decision follows the CHMP opinion that the benefit-risk balance of avacopan had become unfavourable. The reassessment of the pivotal clinical study found the available efficacy data insufficient to compensate for the known serious hepatotoxicity associated with the molecule. Because Tavneos was authorised under the centralised procedure (Regulation (EC) No 726/2004), the marketing authorisation is withdrawn at Union level, not nation by nation: the ANSM recall of August 19, 2026 is the national operationalisation of an EU-level revocation that took effect on August 4.
What is the deadline ladder and who is exposed to sanction?
The prohibition on prescription and dispensation is immediate from August 19, 2026: there is no transition window during which remaining stock may be dispensed. Continuing to prescribe, dispense or distribute a withdrawn centralised authorisation product exposes the operator to the French health police sanctions applicable to breaches of medicines regulations. The exposure is narrow but concrete: one marketing authorisation holder (Vifor France), French retail and hospital pharmacists handling the affected lots, ANCA vasculitis specialist prescribers, and wholesalers-répartiteurs in the distribution chain.
| Date | Authority and act |
|---|---|
| January 11, 2022 | EU centralised marketing authorisation granted for Tavneos (avacopan) |
| January 30, 2026 | EMA opens a safety review of avacopan |
| June 26, 2026 | CHMP recommends revocation of the authorisation |
| July 16, 2026 | ANSM letter to healthcare professionals: stop initiation, switch patients, reinforce hepatic monitoring |
| August 4, 2026 | European Commission Implementing Decision withdrawing the Union marketing authorisation |
| August 19, 2026 | French lot recall begins; prescription and dispensation prohibited |
Take advantage of this real-time watch
Verify whether your establishment holds or dispenses affected Tavneos lots, confirm that no new prescription or renewal has been processed since August 19, 2026, brief dispensing and medical affairs teams on the switch protocol and reinforced hepatic monitoring, and document the return of stock under the Vifor France recall modalities. Obsidian's per-jurisdiction regulatory monitoring surfaces national operational measures like this the moment the supervisor publishes them, even when the legal trigger was an EU-level act weeks earlier.
