Drugs / Vasovist
Vasovist
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Ablavar (previously Vasovist) | — | 2011-10-18 | europa.eu ↗ |
| Approved | US (FDA) | ABLAVAR | — | 2008-12-22 | fda.gov ↗ |
| Approved | EU (EMA) | Ablavar (previously Vasovist) | — | 2005-10-03 | europa.eu ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00296855 | Feb 2006 → Feb 2007 | peripheral arterial disease | Bayer | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02243059 | Sep 2014 | ovarian neoplasm | Maastricht University Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT00668824 | Mar 2007 → Jul 2008 | congenital heart disease | Guy's Hospital | Unknown | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT00415805 Comparator | Dec 2006 → Dec 2008 | arterial disorder | Bracco Diagnostics, Inc | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Vasovist | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00296855 ↗ |
| Known as | BAY86-5283 | “Vasovist (BAY86-5283, MS-325)” NCT00296855 ↗ |
| Known as | gadofosveset | “Vasovist (gadofosveset), a contrast agent not yet available on the market” NCT00296855 ↗ |
| Known as | Gadofosveset trisodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02243059 ↗ |
| Known as | MS-325 | “Vasovist (BAY86-5283, MS-325)” NCT00296855 ↗ |
| Modality | Diagnostic / imaging agent | “two MRA contrast agents” NCT00415805 ↗ |
| Route | Intravenous | “single IV bolus injection of Vasovist” NCT00296855 ↗ |