Approved Risk Evaluation and Mitigation Strategies (REMS)

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Tysabri (natalizumab)
BLA #125104
REMS last update: 10/14/2016

View the Tysabri Prescribing Information and Medication Guide at DailyMed.
View Tysabri's Regulatory Information at Drugs@FDA

What do participants need to know?

See the application holder(s) REMS Website or the approved REMS materials for more information. A general overview of the REMS is currently under development.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:

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.

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