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The goal of the REMS for mifepristone is to mitigate the risk of serious complications associated with
mifepristone by:
Requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone
REMS Program.
Ensuring that mifepristone is only dispensed by or under the supervision of certified prescribers, or
by certified pharmacies on prescriptions issued by certified prescribers.
Informing patients about the risk of serious complications associated with mifepristone.
What do participants need to know?
For a general overview of the REMS for all REMS participants (e.g., healthcare providers, patients, and pharmacies ) refer to the REMS document under the REMS Material tab above.
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
03/23/2023
Modified to revise the Prescriber Agreement Forms to add space to allow for additional contact information on the forms, as well as a
revision to the GenBioPro, Inc. Prescriber Agreement Form to correct a typographical error.
01/03/2023
Modified according to the letter dated December 16, 2021. In addition, modified to:
Revise the REMS goal to align with the updated REMS requirements.
Replace serial number with recording of NDC and lot number of mifepristone
dispensed.
Make additional edits for clarification and consistency in the REMS Document and
REMS materials (Prescriber Agreement Forms, Patient Agreement Form, and
Pharmacy Agreement Forms).
05/14/2021
Modified to revise the Patient Agreement Form to include gender neutral language and minor revisions to the REMS document to be consistent with the revisions to the Patient
Agreement Form.
04/11/2019
Modified to establish a SSS REMS for the elements to
assure safe use and the implementation system required for the reference listed drug (RLD) Mifeprex and ANDAs referencing Mifeprex, called the Mifepristone REMS Program.
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.