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SUBLOCADE REMS Program Fact Sheet How to Obtain SUBLOCADE What is the SUBLOCADE REMS (Risk Evaluation and Mitigation Strategy) Program? A REMS is a strategy to manage known or potential risks associated.

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How to fill out the Sublocade Rems Program online

This guide provides a step-by-step approach to completing the Sublocade Rems Program online. By following these instructions, you will be able to navigate the form with ease and ensure compliance with necessary guidelines.

Follow the steps to complete the Sublocade Rems Program form effectively.

  1. Press the ‘Get Form’ button to obtain the Sublocade Rems Program form and open it in the designated editor.
  2. Begin by providing the required details about your healthcare setting. Include the name and address of the facility, ensuring that all information is accurate and up to date.
  3. Designate an authorized representative for your healthcare setting. This person will be responsible for completing and submitting the enrollment form.
  4. Complete the training compliance section by noting the staff members who have been trained in the proper procedures for dispensing Sublocade.
  5. Verify and establish the processes in place for ensuring that Sublocade is dispensed directly to healthcare providers, not to patients.
  6. Review all entered information for accuracy and completeness before submission.
  7. Once all information is confirmed, save your changes. You can then choose to download, print, or share the completed form as needed.

Complete your Sublocade Rems Program document online today for a smooth and efficient process.

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Related content

Sublocade ( extended-release) NDA ... - FDA
Disclaimer: This webpage provides general information about REMS programs to various REMS...
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sublocade ( extended release injection)
dispense sublocade are subject to the. Sublocade REMS (risk evaluation and mitigation...
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Related links form

GA WC-102b 2011 GA WC-102b 2007 GA WC-200a 2011 GA WC-200b 2011

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The recommended target dosage of sublingual film during maintenance is 16 mg/4 mg /naloxone/day as a single daily dose. Dosages higher than 24 mg/6 mg daily have not been demonstrated to provide a clinical advantage.

The FTC says that these companies violated antitrust laws by preventing patients from choosing lower-priced generic versions of the drug. In May 2021, the FTC sent payments totaling more than $59 million to people who filed a valid claim.

The goal of the REMS is to mitigate the risk of serious harm or death that could result from intravenous self-administration.

Is there a REMS for ? Yes, a REMS has been implemented as part of the FDA requirements to ensure that the benefits of treatment with outweigh the potential risks, particularly risks of accidental overdose, misuse, and abuse.

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.

If you have Medicare Part B, your supplemental, commercial insurance may cover all or part of your medication costs, including Sublocade. If you have Medicare Part C, there is an out-of-pocket maximum that you will pay, depending on your plan's benefits and other expenses you have in the year.

Yes, Sublocade () is classified by the DEA as a schedule 3 controlled substance with moderate abuse potential. Medicines in schedule 3 have a potential for abuse less than those in schedule 1 and 2 (for example, heroin or ).

What drug tier is / naloxone typically on? Medicare prescription drug plans typically list / naloxone on Tier 2 of their formulary. Generally, the higher the tier, the more you have to pay for the medication.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
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
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
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 WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
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