Tavneos
avacopan
Table of contents
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).
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Tavneos : EPAR - Medicine Overview (PDF/120.14 KB)
First published: 26/01/2022
EMA/686677/2021 -
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Tavneos : EPAR - Risk management plan summary (PDF/148.11 KB)
First published: 26/01/2022
Authorisation details
Product details | |
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Name |
Tavneos
|
Agency product number |
EMEA/H/C/005523
|
Active substance |
Avacopan
|
International non-proprietary name (INN) or common name |
avacopan
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L04
|
Additional 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. |
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. |
Publication details | |
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Marketing-authorisation holder |
Vifor Fresenius Medical Care Renal Pharma France
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
11/01/2022
|
Contact address |
100-101 Terrasse Boieldieu |
Product information
25/11/2022 Tavneos - EMEA/H/C/005523 - IB/0004
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).
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).