View Mifeprex's Regulatory Information at Drugs@FDA
REMS last update: 03/29/2016
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).
Healthcare Providers who prescribe and dispense Mifeprex must
|To be able to prescribe||
Patients who are prescribed Mifeprex
Distributors that distribute Mifeprex must
|To be able to distribute||
|At all times||
What materials are included in the REMS?
The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:
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.