Jylamvo (methotrexate)
- Region
- 🇪🇺 EU
- Active substance
- methotrexate
- Company
- Oresund Pharma ApS
- Status
- Authorised
- Therapeutic area
- Arthritis, Psoriatic; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Psoriasis; Arthritis, Rheumatoid; Arthritis
- CHMP opinion
- Thu 26 Jan 2017
- EU approval
- Wed 29 Mar 2017
- Application
- EMEA/H/C/003756
- ATC
- L04AX03
- Official record
- www.ema.europa.eu
Indication
In rheumatological and dermatological diseases Active rheumatoid arthritis in adult patients. Polyarthritic forms of active, severe juvenile idiopathic arthritis (JIA) in adolescents and children aged 3 years and over when the response to non-steroidal anti-inflammatory drugs (NSAIDs) has been inadequate. Severe, treatment-refractory, disabling psoriasis which does not respond sufficiently to other forms of treatment such as phototherapy, psoralen and ultraviolet A radiation (PUVA) therapy and retinoids, and severe psoriatic arthritis in adult patients. In oncology Maintenance treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children aged 3 years and over.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Nordimet Authorised · Nordic Group B.V.
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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.