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 |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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09/08/2023 | |
05/18/2022 | Revised to reflect editorial changes. |
05/05/2022 | Modified to make changes to the Prescriber Education Slide Deck to align with the REMS modification approved October 18, 2021 and add a link on the REMS website to the “Letter for Healthcare Providers” and to update the Terms of Use page version and date information. |
10/18/2021 | Modified to:
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08/05/2019 | Revised website screenshots to remove individual applicant names. |
11/22/2016 | Modified to reflect the inclusion of an additional ANDA into the alosetron REMS. |
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.