EMA 撤销 Tavneos（avacopan）在欧盟的上市许可
Human medicines European public assessment report (EPAR): Tavneos, avacopan, Date of authorisation: 11/01/2022, Revision: 9, Status: Revoked
欧盟委员会于 2026 年 8 月 4 日通过实施决定，撤销 Tavneos（avacopan）的上市许可。该药此前于 2022 年 1 月 11 日获批，与利妥昔单抗或环磷酰胺方案联用，治疗成人严重活动性肉芽肿性多血管炎（GPA）或显微镜下多血管炎（MPA）。EMA 页面显示其最新产品信息相关程序为 PSUSA/00010967/202403，日期为 2025 年 1 月 15 日。
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation of Tavneos was revoked by the Commission Implementing Decision of 4 August 2026.
Product information
Latest procedure affecting product information:PSUSA/00010967/202403
15/01/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
Name of medicine
Tavneos
Active substance
avacopan
International non-proprietary name (INN) or common name
avacopan
Therapeutic area (MeSH)
- Microscopic Polyangiitis
- Wegener Granulomatosis
Anatomical therapeutic chemical (ATC) code
L04
Pharmacotherapeutic group
Immunosuppressants
Therapeutic indication
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).
EMA product number
EMEA/H/C/005523
PRIME: priority medicine
This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.
Marketing authorisation holder
Vifor Fresenius Medical Care Renal Pharma France
100-101 Terrasse Boieldieu
Tour Franklin- La Défense 8
92042 Paris la Défense Cedex
FranceOpinion adopted
11/11/2021
Marketing authorisation issued
11/01/2022
Revocation of marketing authorisation
04/08/2026
Revision
9
More information on Tavneos
This page was last updated on 30/10/2026
来源：EMA What's New · ema.europa.eu