Tavneos

Revoked

This medicine's authorisation has been revoked

avacopan

Overview

The marketing authorisation of Tavneos was revoked by the Commission Implementing Decision of 4 August 2026.

Tavneos : EPAR - Medicine Overview

Reference Number: EMA/686677/2021

Tavneos : EPAR - Risk management plan

Product information

Tavneos : EPAR - Product Information

Tavneos : EPAR - All authorised presentations

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).

Authorisation details

• EMA product number:
  EMEA/H/C/005523
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• 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; France

• Opinion adopted:
  11/11/2021
• Marketing authorisation issued:
  11/01/2022
• Revocation of marketing authorisation:
  04/08/2026
• Revision:
  9

Assessment history

Changes since initial authorisation of medicine

Tavneos : EPAR - Procedural steps taken and scientific information after authorisation

Tavneos : EPAR - Procedural steps taken and scientific information after authorisation (archive)

Tavneos-H-C-PSUSA-00010967/202403 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/517000/2024

Tavneos : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Reference Number: EMA/249662/2024

Tavneos-H-C-005523-P46-006 : EPAR - Assessment report

Adopted Reference Number: EMA/CHMP/286099/2023

Tavneos-H-C-005523-P46-003 - EPAR - Assessment report

Adopted Reference Number: EMA/CHMP/64582/2023

Initial marketing authorisation documents

Tavneos : EPAR - Public Assessment Report

Adopted Reference Number: EMA/708044/2021 Corr

Tavneos : EPAR - Orphan Medicine Assessment Report (initial authorisation)

Adopted Reference Number: EMADOC-1700519818-748110

CHMP summary of positive opinion for Tavneos

Adopted Reference Number: EMA/CHMP/624375/2021