Dimethyl fumarate Teva (dimethyl fumarate)
Generic
- Region
- 🇪🇺 EU
- Active substance
- dimethyl fumarate
- Company
- Teva GmbH
- Status
- Revoked
- Therapeutic area
- Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
- CHMP opinion
- Thu 13 Oct 2022
- EU approval
- Mon 12 Dec 2022
- Designations
- Generic
- Application
- EMEA/H/C/005963
- ATC
- L04AX07
- Official record
- www.ema.europa.eu
Indication
Dimethyl fumarate Teva 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
- 🇪🇺 Tecfidera Authorised · Biogen Netherlands B.V.
- 🇪🇺 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 Accord Revoked · Accord Healthcare S.L.U.
- 🇪🇺 Dimherity Application withdrawn · Sandoz GmbH
Follow Dimethyl fumarate Teva
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.