Is Avacopan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Avacopan, including Tavneos (10 mg, Capsule, hard, SAR 28159.35).

Is Avacopan approved by the US FDA?

Drugs@FDA lists 1 application product line for Avacopan, including TAVNEOS (Prescription).

Is Avacopan authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Avacopan.

Are there safety signals or safety updates for Avacopan?

US FDA: 1 entry (latest 2024-06-03).

Active substance

Avacopan

SFDA 1
US FDA 1
EMA 2
Health Canada 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Tavneos	10 mg	Capsule, hard · Oral use	180 Bottle	SAR 28159.35	NCE · Prescription	Vifor Fresenius Medical Care Renal Pharma	Valid

Indications — CHI Daman Drug Formulary

GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
TAVNEOS	10MG	capsule · oral	CHEMOCENTRYX	Prescription	7 Oct 2021

EMA European Union — centrally authorised medicines

Vynpenta (previously AvacopanChemoCentryx) ChemoCentryx Ltd · Application withdrawn · ATC L04

Therapeutic indication (EMA)

Induction of response in adult patients with granulomatosis with polyangiitis (Wegener’s) (GPA) or microscopic polyangiitis (MPA)

Tavneos Vifor Fresenius Medical Care Renal Pharma France · Revoked · authorised 11 Jan 2022 · ATC L04

Therapeutic indication (EMA)

Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
TAVNEOS	02526662	10 MG	CAPSULE · ORAL	VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD

Safety signals and safety-related labeling changes

US FDA 3 Jun 2024 TAVNEOS — safety-related labeling change
Labeling sections changed: Drug Interactions

All safety entries for avacopan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.