JAKAFI® (Ruxolitinib) 15mg
| Product Overview | |
| Generic Name | JAKAFI® (Ruxolitinib) 15mg |
| Brand Name(s) | Jakafi®, Jakavi® |
| Product Type | Originator Brand |
| Form | 60 Oral tablets; |
| Strength | 15mg immediate release |
| Therapeutic Class | Janus kinase inhibitor; selective JAK1/JAK2 inhibitor |
| ATC Code | L01EJ01 |
| Manufacturing & Regulatory | |
| Manufacturer | INCYTE Corp |
| Country | U.S. |
| GMP Compliance | FDA/EMA/WHO-GMP |
| COFEPRIS | 010.000.6094.00 |
| Free Sale Certificate | may obtain export certificate from regulatory authority |
| Logistics & Export | |
| MOQ | 2 units |
| Shelf Life | 24 Months |
| Storage | Store at 20–25 °C |
| Incoterms | EXW, HSN 30049099 |
| Lead Time | 7 - 10 Business Days |
| Documentation | |
| Certificate of Analysis (COA) | Supplied per batch upon request |
| SDS | Manufacturer provides standard SDS (biologic/aqueous injectable) |
| CTD Summary | Not publicly available |
Description
JAKAFI/JAKAVI® (ruxolitinib) 15mg x 60 tab is an oral JAK1/JAK2 inhibitor used mainly for intermediate/high-risk myelofibrosis, polycythemia vera after inadequate response/intolerance to hydroxyurea, and acute or chronic graft-versus-host disease after failure of prior therapy
