Fingolimod 0.5mg
| Product Overview | |
| Generic Name | Fingolimod 0.5mg |
| Brand Name(s) | Tascenso ODT®, Gilenya® |
| Product Type | Generic |
| Form | 28 hard gelatin capsules |
| Strength | 0.5 mg |
| Therapeutic Class | Sphingosine-1-phosphate receptor modulator / immunomodulator |
| ATC Code | L04AE01 |
| Manufacturing & Regulatory | |
| Manufacturer | Sun, Teva |
| Country | Canada, India, Mexico |
| GMP Compliance | WHO-GMP |
| DMF/CEP | DMF 028165 |
| COFEPRIS | 010.000.5815.00 |
| Free Sale Certificate | Yes, available as COPP/CPP |
| Logistics & Export | |
| MOQ | 5 units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HS/HSN: 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Possible SDS for oral immunomodulator |
| CTD Summary | CTD proprietary; available under commercial agreement/license |
Description
Generic (Fingolimod) is used for relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in patients 10 years and older. It requires specialist supervision because of first-dose bradycardia/AV-conduction monitoring, infection risk, macular oedema, liver injury, malignancy risk and rebound disease activity after discontinuation.
