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Tavneos (avacopan)

PRIMEAdditional monitoring
Region
🇪🇺 EU
Active substance
avacopan
Company
Vifor Fresenius Medical Care Renal Pharma France
Status
Revoked
Therapeutic area
Microscopic Polyangiitis; Wegener Granulomatosis
CHMP opinion
Thu 11 Nov 2021
EU approval
Tue 11 Jan 2022
Designations
PRIME, Additional monitoring
Application
EMEA/H/C/005523
ATC
L04
Official record
www.ema.europa.eu

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).

Regulatory milestones

Tue 04 Aug 2026🇪🇺 Referral EC decision

Tavneos: EC decision

Article 20 procedures; European Commission final decision · source

Thu 16 Jul 2026🇪🇺 DHPC safety letter

Tavneos (avacopan): DHPC sent to healthcare professionals

Referral - Article 20 procedure; Microscopic Polyangiitis, Wegener Granulomatosis · source

Thu 25 Jun 2026🇪🇺 Referral opinion

Tavneos: CHMP opinion

Article 20 procedures; European Commission final decision · source

Thu 29 Jan 2026🇪🇺 Referral started

Tavneos: referral started

Article 20 procedures; European Commission final decision · source

Same substance in other markets

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.