Drugs / Rosiglitazone/metformin
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT00069836 | Oct 2003 → Nov 2004 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2011-02-07 | GlaxoSmithKline | Regulatory GSK revises US Avandia label to include new restrictions on use gsk.com ↗
GlaxoSmithKline (GSK) today announced revised US prescribing information and medication guides for all rosiglitazone-containing medicines (Avandia®, Avandamet® and Avandaryl®) to include additional safety information and restrictions on the use of these medicines. |
| 2010-09-22 | GlaxoSmithKline | Regulatory GSK regulatory update on Avandia following EMA and FDA reviews gsk.com ↗
In the European Union*, the EMA has suspended the marketing authorisation for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2011-02-07 | GlaxoSmithKline | GSK revises US Avandia label to include new restrictions on use gsk.com ↗ |
| 2010-09-22 | GlaxoSmithKline | GSK regulatory update on Avandia following EMA and FDA reviews gsk.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Rosiglitazone/metformin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00069836 ↗ |
| Known as | AVANDAMET | “AVANDAMET capsules contain a fixed dose of AVANDIA and metformin.” NCT00069836 ↗ |