miércoles, 4 de noviembre de 2015

REMS@FDA: Approved Risk Evaluation and Mitigation Strategies (REMS) website updated

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REMS@FDA has been updated with the following new or updated information. This information can be found on the following REMS-specific webpage(s):

1.   ThalomidRevlimid, and Pomalyst REMS modified on (October 27, 2015) to remove an ICD-10 code from the Patient Prescription Forms.
2.   ER/LA opioid analgesics shared system REMS modified (on October 23, 2015) to add Belbuca product information.
3.   Sabril REMS revised (on October 22, 2015).
4.   Extraneal REMS modified (on October 16, 2015) to align the REMS with the revised label approved in the December 9, 2014, Supplement Approval letter (S-028) for the conversion of the Extraneal label to the Physician’s Labeling Rule.

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