Drugs / SynflorixTM
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01340898 | Jan 2012 → Aug 2014 | meningococcal infection | GlaxoSmithKline | Completed | Met primary |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2017-06-27 | GlaxoSmithKline | Regulatory GSK receives CHMP positive opinion for Synflorix pneumococcal vaccine four-dose vial gsk.com ↗
GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a new four-dose vial presentation of its Synflorix pneumococcal vaccine. |
| 2015-07-27 | GlaxoSmithKline | Regulatory GSK’s Synflorix™ receives CHMP positive opinion for major label extension gsk.com ↗
GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the expansion of the SynflorixTM European label. |
| 2015-03-26 | GlaxoSmithKline | Regulatory GSK receives approval for Encruse® Ellipta® in Japan for the treatment of COPD gsk.com ↗
Synflorix™, a pneumococcal conjugate paediatric vaccine, was also approved today by the MHLW, with an indication for the prevention of invasive infectious diseases and pneumonia caused by pneumococcus (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-06-27 | GlaxoSmithKline | GSK receives CHMP positive opinion for Synflorix pneumococcal vaccine four-dose vial gsk.com ↗ |
| 2015-07-27 | GlaxoSmithKline | GSK’s Synflorix™ receives CHMP positive opinion for major label extension gsk.com ↗ |
| 2015-03-26 | GlaxoSmithKline | GSK receives approval for Encruse® Ellipta® in Japan for the treatment of COPD gsk.com ↗ |
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SynflorixTM | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01340898 ↗ |