Approved Risk Evaluation and Mitigation Strategies (REMS)
Shared System REMS
REMS last update:
What is the purpose of the REMS?
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
What assessment is available to the REMS?
| Assessment Plan |
|---|
| REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
| Date | Summary of change |
|---|---|
| 12/16/2015 | |
| 05/07/2014 | Changes outlined in the November 25, 2013 letter, including removal of the Medication Guide as an element of the REMS and modification of the elements to assure safe use. |
| 09/16/2013 | Revised package insert and Medication Guide to change the description of the tablets to reflect a change in the imprint on the tablets from “SB” to “GSK” for all tablet strengths of Avandia. |
| 01/25/2013 |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.