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Outpatient Healthcare Settings

SPRAVATO® REMS Outpatient Healthcare Setting Enrollment

Outpatient Healthcare Settings must be certified in the SPRAVATO® REMS in order to prescribe product.

SPRAVATO® is intended for patient administration under the direct observation of a healthcare provider, due to risks of serious adverse outcomes resulting from sedation and dissociation caused by SPRAVATO administration, and abuse and misuse of SPRAVATO. SPRAVATO® is intended for use only in a certified Healthcare Setting.

Outpatient Healthcare Settings are required to enroll patients prior to patient treatment and submit Patient Monitoring Forms  after each patient treatment to the SPRAVATO® REMS.

Outpatient Healthcare Setting Enrollment is intended only for outpatient medical offices and clinics.
Emergency departments within hospitals are certified through the Inpatient Healthcare Setting enrollment.

How does my Outpatient Healthcare Setting become certified in the SPRAVATO® REMS?

Step 1: Designate an Authorized Representative to oversee implementation and compliance with the REMS requirements.

Step 2: Review the following materials:

  • SPRAVATO® Prescribing Information
  • SPRAVATO® REMS Program Overview

Step 3: Complete and submit the SPRAVATO® REMS Outpatient Healthcare Setting Enrollment Form to the REMS.

OnlineBy Fax

PDFs for Download: Resources for Outpatient Healthcare Settings

For SPRAVATO® REMS Program information contact: Phone: 1-855-382-6022 Fax: 1-877-778-0091

Healthcare providers should report suspected adverse events or product quality complaints associated with SPRAVATO® to Janssen at 1-800-JANSSEN (1-800-526-7736) or the FDA at 1-800-FDA-1088 or online at www.fda.gov/medwatch.

This site is published by Janssen Pharmaceuticals Inc., which is solely responsible for its contents. This site is intended for use by healthcare professionals in the United States and Puerto Rico. Janssen Pharmaceuticals, Inc. recognizes that the internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

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©Janssen Pharmaceuticals, Inc. 2020 08/2020