Tecfidera (dimethyl fumarate)
- Region
- 🇪🇺 EU
- Active substance
- dimethyl fumarate
- Company
- Biogen Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Multiple Sclerosis
- CHMP opinion
- Thu 21 Mar 2013
- EU approval
- Thu 30 Jan 2014
- Application
- EMEA/H/C/002601
- ATC
- L04AX07
- Official record
- www.ema.europa.eu
Indication
Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
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
- 🇪🇺 Skilarence Authorised · Almirall, S.A.
- 🇪🇺 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- 🇪🇺 Dimherity Application withdrawn · Sandoz GmbH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.