Tavneos

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avacopan

Authorised
This medicine is authorised for use in the European Union.

Overview

Tavneos is a medicine used to treat adults with severe, active granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) or microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels. Tavneos is used as part of a combined treatment also including the medicines rituximab or cyclophosphamide.

Tavneos contains the active substance avacopan.

GPA and MPA are rare, and Tavneos was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (GPA: 19 November 2014; MPA: 19 November 2014).

This EPAR was last updated on 25/11/2022

Authorisation details

Product details
Name
Tavneos
Agency product number
EMEA/H/C/005523
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
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

OrphanOrphan

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.

Publication details
Marketing-authorisation holder
Vifor Fresenius Medical Care Renal Pharma France
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
11/01/2022
Contact address

100-101 Terrasse Boieldieu
Tour Franklin- La Défense 8
92042 Paris la Défense Cedex
France

Product information

25/11/2022 Tavneos - EMEA/H/C/005523 - IB/0004

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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).

Assessment history

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