Nordimet (methotrexate)
- Region
- 🇪🇺 EU
- Active substance
- methotrexate
- Company
- Nordic Group B.V.
- Status
- Authorised
- Therapeutic area
- Arthritis, Psoriatic; Psoriasis; Arthritis, Juvenile Rheumatoid; Arthritis, Rheumatoid
- CHMP opinion
- Thu 23 Jun 2016
- EU approval
- Thu 18 Aug 2016
- Application
- EMEA/H/C/003983
- ATC
- L04AX03
- Official record
- www.ema.europa.eu
Indication
Nordimet is indicated for the treatment of: active rheumatoid arthritis in adult patients, polyarthritic forms of severe, active juvenile idiopathic arthritis (JIA), when the response to nonsteroidal anti-inflammatory drugs (NSAIDs) has been inadequate, moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, and severe psoriatic arthritis in adult patients, induction of remission in moderate steroid-dependent Crohn's disease in adult patients, in combination with corticosteroids and for maintenance of remission, as monotherapy, in patients who have responded to methotrexate.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Jylamvo Authorised · Oresund Pharma ApS
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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.