Skilarence (dimethyl fumarate)
- Region
- 🇪🇺 EU
- Active substance
- dimethyl fumarate
- Company
- Almirall, S.A.
- Status
- Authorised
- Therapeutic area
- Psoriasis
- CHMP opinion
- Fri 21 Apr 2017
- EU approval
- Fri 23 Jun 2017
- Application
- EMEA/H/C/002157
- ATC
- L04AX07
- Official record
- www.ema.europa.eu
Indication
Skilarence is indicated for the treatment of moderate to severe plaque psoriasis in adults in need of systemic medicinal therapy.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Dimethyl fumarate Mylan Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Dimethyl fumarate Accord Authorised · Accord Healthcare Ltd
- 🇪🇺 Tecfidera Authorised · Biogen Netherlands B.V.
- 🇪🇺 Dimethyl fumarate Neuraxpharm Authorised · Neuraxpharm Pharmaceuticals S.L.
- 🇪🇺 Dimethyl fumarate Polpharma Revoked · Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- 🇪🇺 Dimethyl fumarate Mylan Revoked · Mylan Ireland Limited
- 🇪🇺 Dimethyl fumarate Neuraxpharm Revoked · Laboratorios Lesvi S.L.
- 🇪🇺 Dimethyl fumarate Teva Revoked · Teva GmbH
- 🇪🇺 Dimethyl fumarate Accord Revoked · Accord Healthcare S.L.U.
- 🇪🇺 Dimherity Application withdrawn · Sandoz GmbH
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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.