Dimethyl fumarate Polpharma (dimethyl fumarate)
Generic
- Region
- 🇪🇺 EU
- Active substance
- dimethyl fumarate
- Company
- Zaklady FarmaFarmaceutyczne Polpharma S.Aceutyczne Polpharma S.A.
- Status
- Revoked
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting
- CHMP opinion
- Thu 24 Feb 2022
- EU approval
- Fri 13 May 2022
- Designations
- Generic
- Application
- EMEA/H/C/005955
- ATC
- L04AX07
- Official record
- www.ema.europa.eu
Indication
Dimethyl fumarate Polpharma is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.
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.
- 🇪🇺 Skilarence Authorised · Almirall, S.A.
- 🇪🇺 Dimethyl fumarate Neuraxpharm Authorised · Neuraxpharm Pharmaceuticals S.L.
- 🇪🇺 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- 🇪🇺 Dimherity Application withdrawn · Sandoz GmbH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.