Drugs / Kepivance
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Kepivance | — | 2016-04-01 | europa.eu ↗ |
| Label expansion | US (FDA) | KEPIVANCE | — | 2011-11-14 | fda.gov ↗ |
| Approved | EU (EMA) | Kepivance | — | 2005-10-25 | europa.eu ↗ |
| Approved | US (FDA) | KEPIVANCE | — | 2004-12-15 | fda.gov ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00352703 | Apr 2006 → Apr 2007 | non-Hodgkin lymphoma, plasma cell myeloma | Swedish Orphan Biovitrum | Completed | No outcome recorded |
Press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2010-03-23 | Sobi, Inc. | Swedish Orphan Biovitrum updates European Kepivance® label sobi.com ↗ |
| 2008-09-15 | Sobi, Inc. | Biovitrum to Acquire Kepivance® and Stemgen® and Exclusively LicenseKineret® from Amgen sobi.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Kepivance | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00352703 ↗ |
| Known as | Palifermin | “Kepivance (Palifermin)” NCT00352703 ↗ |
| Route | Intravenous | “60 μg/kg/day IV for 3 consecutive days before the conditioning regimen and 3 consecutive days after the peripheral blood stem cell transplantation.” NCT00352703 ↗ |