Drugs / Pumarix
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Pumarix | — | 2015-02-11 | europa.eu ↗ |
| Approved | EU (EMA) | Pumarix | — | 2011-03-04 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT00510874 | Jul 2007 → Jun 2008 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2012-03-05 | GlaxoSmithKline | Regulatory Regulatory Update: GSK announces submissions for two influenza vaccines gsk.com ↗
A regulatory application has also been submitted to the U.S. FDA seeking approval for an H5N1 influenza vaccine. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2012-03-05 | GlaxoSmithKline | Regulatory Update: GSK announces submissions for two influenza vaccines gsk.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 | Pumarix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00510874 ↗ |
| Modality | Vaccine | “candidate influenza vaccine” NCT00510874 ↗ |
| Route | Intramuscular | “Two doses administered intramuscularly (IM)” NCT00510874 ↗ |