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Patient Name: APPROPRIATE USE CHECKLIST: BUPRENORPHINECONTAINING TRANSMUCOSAL PRODUCTS FOR OPIOID DEPENDENCE This checklist is a useful reminder of the safe use conditions and monitoring requirements.

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They are required when certain specific risks exist that might otherwise limit the approvability and use of medications. At this time, there are 76 REMS approved by the FDA, and a link below can be used to access a full list of REMS.

Which pain medicines are included in this REMS? The branded and generic drug products subject to this REMS include all the following: Oral dosage forms containing: codeine and codeine analogs, , , , meperidine, , , , , , .

FDA determines if a REMS is necessary. The agency may seek information from outside experts or other participants (e.g., patients and health care providers), or may seek advice through an FDA advisory committee in making this determination.

Types of REMS Requirements. REMS include a risk mitigation goal, and are comprised of information communicated to and/or required activities to be undertaken by one or more participants (e.g., health care providers, pharmacists, patients) who prescribe, dispense or take the medication.

The drug products subject to the -containing Transmucosal products for Opioid Dependence (BTOD) REMS include: ® () sublingual tablets and generic equivalents. ® ( and naloxone) sublingual tablets and sublingual films and generic equivalents.

Which pain medicines are included in this REMS? Oral dosage forms containing: codeine and codeine analogs, , , , meperidine, , , , , , . Intranasal .

These medications are , esketamine (Spravato) and for extended-release injectable suspension (® Relprevv™).

Risk Evaluation and Mitigation Strategies (REMS)

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232