Approved Risk Evaluation and Mitigation Strategies (REMS)Contact Us | REMS Basics | | Data Files
View Addyi's Regulatory Information at Drugs@FDA
REMS last update: 08/18/2015
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 product-specific REMS website or the approved REMS materials for more information.
Healthcare Providers who prescribe Addyi must
Patients who are prescribed Addyi
Outpatient pharmacies that dispense Addyi must
Inpatient pharmacies that dispense Addyi must
Wholesalers that distribute Addyi must
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:
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