Mycophenolate REMS

Prescriber
Overview

Patient
Overview

Other Healthcare
Professionals Overview

REMS
Materials

Report a
Pregnancy

Additional
Resources

FAQs

Prescribers

Resources and Educational Materials for Prescribers

Your REMS Materials:

Patient Information Brochure: What You Need To Know About Mycophenolate

For prescribers to give to female patients of reproductive potential
Contains the tools and materials to help patients understand the components of the Mycophenolate REMS

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Healthcare Provider Brochure

For prescribers
Contains information on the risks associated with exposure to mycophenolate during pregnancy, the components of the Mycophenolate REMS, and what you can do to help ensure the successful implementation of the program

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Dear Healthcare Provider (DHCP) Letter

For prescribers
Contains important information about the Mycophenolate REMS

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Dear Healthcare Provider (DHCP) Letter for Centers

For healthcare centers
Contains important information about the Mycophenolate REMS for healthcare centers

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Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients

For prescribers to give to female patients of reproductive potential

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Prescriber Training Confirmation Form

For prescribers
This form can be used to document training in the Mycophenolate REMS. The form can be filled out and mailed or faxed to document your training.

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CellCept Medication Guide

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Myfortic Medication Guide

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Generic Medication Guides

Drug Name	Generic Name	Company	Links
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Accord Healthcare, Inc.	Medication Guide
Mycophenolate Mofetil for Injection, USP	Mycophenolate Mofetil	Akorn, Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Alkem Laboratories, Ltd.	Medication Guide
Mycophenolate Mofetil powder, for suspension	Mycophenolate Mofetil	Alkem Laboratories, Ltd.	Medication Guide
Mycophenolate Mofetil Capsule	Mycophenolate Mofetil	Concord Biotech Limited	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Hikma Pharmaceuticals USA Inc.	Medication Guide
Mycophenolate Mofetil Capsule	Mycophenolate Mofetil	Hisun Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Tablet	Mycophenolate Mofetil	Hisun Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Jubilant Cadista Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Mylan Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil for Injection, USP	Mycophenolate Mofetil	Par Pharmaceutical.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Strides Pharma Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Sandoz Incorporated	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Teva Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Capsule	Mycophenolate Mofetil	Vintage Pharmaceuticals, LLC.	Approved, but not currently marketed
Mycophenolate Mofetil Tablet	Mycophenolate Mofetil	Vintage Pharmaceuticals, LLC.	Approved, but not currently marketed
Mycophenolate Mofetil for Oral Suspension	Mycophenolate Mofetil	VistaPharm, Inc.	Medication Guide
Mycophenolate Mofetil Injection, Powder, Lyophilized, for Solution	Mycophenolate Mofetil	Zydus Pharmaceuticals (USA) Inc.	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	Accord Healthcare, Inc.	Medication Guide
Mycophenolate Sodium Tablet, Delayed Release	Mycophenolic Acid	Apotex Corp.	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	Teva Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Tablet	Mycophenolate Mofetil	Concord Biotech Limited	Medication Guide
Mycophenolate Mofetil for Injection, USP	Mycophenolate Mofetil	Mylan Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil for Injection USP	Mycophenolate Mofetil	Meitheal Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil for Injection USP	Mycophenolate Mofetil	Amneal Pharmaceuticals LLC	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	AMTA LABS LIMITED	Medication Guide

The Mycophenolate Applicants attest that this page will only include Medication Guides from the list of approved application numbers and applicants on the FDA approved REMS website.

Patients

Resources and Educational Materials for Patients

Your REMS Materials:

Patient Information Brochure: What You Need To Know About Mycophenolate

For female patients of reproductive potential
Helps patients understand the program and how to comply with its requirements

View to Print or Save

Mycophenolate Pregnancy Registry Frequently Asked Questions for Patients

For prescribers to give to female patients of reproductive potential

View to Print or Save

Other Healthcare Professionals

Resources and Educational Materials for Other Healthcare Professionals

Your REMS Materials:

Patient Information Brochure: What You Need To Know About Mycophenolate

For prescribers to give to female patients of reproductive potential
Contains the tools and materials to help patients understand the components of the Mycophenolate REMS

View to Print or Save

Healthcare Provider Brochure

For prescribers
Contains information on the risks associated with exposure to mycophenolate during pregnancy, the components of the Mycophenolate REMS, and what you can do to help ensure the successful implementation of the program

View to Print or Save

CellCept Medication Guide

View to Print or Save

Myfortic Medication Guide

View to Print or Save

Generic Medication Guides

Drug Name	Generic Name	Company	Links
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Accord Healthcare, Inc.	Medication Guide
Mycophenolate Mofetil for Injection, USP	Mycophenolate Mofetil	Akorn, Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Alkem Laboratories, Ltd.	Medication Guide
Mycophenolate Mofetil powder, for suspension	Mycophenolate Mofetil	Alkem Laboratories, Ltd.	Medication Guide
Mycophenolate Mofetil Capsule	Mycophenolate Mofetil	Concord Biotech Limited	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Hikma Pharmaceuticals USA Inc.	Medication Guide
Mycophenolate Mofetil Capsule	Mycophenolate Mofetil	Hisun Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Tablet	Mycophenolate Mofetil	Hisun Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Jubilant Cadista Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Mylan Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil for Injection, USP	Mycophenolate Mofetil	Par Pharmaceutical.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Strides Pharma Inc.	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Sandoz Incorporated	Medication Guide
Mycophenolate Mofetil Capsule/Tablet	Mycophenolate Mofetil	Teva Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Capsule	Mycophenolate Mofetil	Vintage Pharmaceuticals, LLC.	Approved, but not currently marketed
Mycophenolate Mofetil Tablet	Mycophenolate Mofetil	Vintage Pharmaceuticals, LLC.	Approved, but not currently marketed
Mycophenolate Mofetil for Oral Suspension	Mycophenolate Mofetil	VistaPharm, Inc.	Medication Guide
Mycophenolate Mofetil Injection, Powder, Lyophilized, for Solution	Mycophenolate Mofetil	Zydus Pharmaceuticals (USA) Inc.	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	Accord Healthcare, Inc.	Medication Guide
Mycophenolate Sodium Tablet, Delayed Release	Mycophenolic Acid	Apotex Corp.	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	Mylan Pharmaceuticals Inc.	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	Teva Pharmaceuticals USA, Inc.	Medication Guide
Mycophenolate Mofetil Tablet	Mycophenolate Mofetil	Concord Biotech Limited	Medication Guide
Mycophenolate Mofetil for Injection, USP	Mycophenolate Mofetil	Mylan Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil for Injection USP	Mycophenolate Mofetil	Meitheal Pharmaceuticals Inc.	Medication Guide
Mycophenolate Mofetil for Injection USP	Mycophenolate Mofetil	Amneal Pharmaceuticals LLC	Medication Guide
Mycophenolic Acid Tablet, Delayed Release	Mycophenolic Acid	AMTA LABS LIMITED	Medication Guide

The Mycophenolate Applicants attest that this page will only include Medication Guides from the list of approved application numbers and applicants on the FDA approved REMS website.


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