Approved Risk Evaluation and Mitigation Strategies (REMS)
Zinbryta (daclizumab)
BLA #761029
REMS last update: 05/01/2018
What is the purpose of the REMS?
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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05/01/2018 | Application revoked |
11/01/2017 | Modified to:
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03/10/2017 | Revised to make an editorial change and correct a typographical error(s). |
05/27/2016 | Approval of the REMS. |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.