FDA MedWatch - 2009 Safety Alerts for Human Medical Products: "CellCept (mycophenolate mofetil)
Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
[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.
[January 2009 - Dear Healthcare Provider Letter - Roche]
[January 2009 - Dear Pharmacist Letter - Roche]
[December 2008 - Medication Guide - Roche]
[May 2008 - Prescribing Information - Roche]"
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