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U.S. Department of Health and Human Services

Safety

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CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

[UPDATE 03/24/2009] FDA and Novartis notified healthcare professionals of the introduction of a Myfortic Medication Guide to provide important safety information in language that patients can easily comprehend. By May 15, 2009, a copy of the Myfortic Medication Guide will be enclosed with every Myfortic bottle. Pharmacists are required to distribute a copy of the Medication Guide with every Myfortic prescription.

[Posted 02/12/2009] FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

[March 2009 - Dear Healthcare Professional Letter - Myfortic - Novartis]
[December 2008 - Prescribing Information - Myfortic - Novartis]
[March 2009 - Medication Guide - Myfortic - Novartis]
[January 2009 - Dear Healthcare Provider Letter - Roche]

[January 2009 - Dear Pharmacist Letter - Roche]

[December 2008 - Medication Guide - Roche]

[May 2008 - Prescribing Information - Roche]