| Product No | EMEA/H/C/003983 |
|---|---|
| Brand Name | Nordimet |
| Nonproprietary Name | methotrexate |
| API | Methotrexate |
| ATC Code | L04AX03 |
| Indications | 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,severe recalcitrant disabling psoriasis, which is not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, 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. |
| Orphan Drug | no |
| Generics | no |
| Marketing Authorization Holder | Nordic Group B.V. |
| Status | Authorised(授权) |
| Authorization Date | 2016-08-18 |
| Version | 18 |
| Condition Approval | no |
| Exceptions | no |
| Biosimilar | no |
| Details | 查看 (公众评估报告、授权细节、产品规格/剂型、标签、历史评估信息) |
Extended Information