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Approved Risk Evaluation and Mitigation Strategies (REMS)

Pomalidomide
Shared System REMS
REMS last update: 10/30/2020

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Pomalidomide (Info at Drugs@FDA) ANDA 210249 EUGIA PHARMA 10/30/2020
Pomalidomide (Info at Drugs@FDA) ANDA 210111 BRECKENRIDGE 10/30/2020
Pomalidomide (Info at Drugs@FDA) ANDA 210275 MYLAN 01/26/2022
Pomalidomide (Info at Drugs@FDA) ANDA 209956 TEVA PHARMS USA 05/04/2022

What is the purpose of the REMS?

The goals of the Pomalidomide REMS are as follows:

  1. To prevent the risk of embryo-fetal exposure to pomalidomide.
  2. To inform prescribers, patients, and pharmacists on the serious risks and safe-use conditions for pomalidomide.

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.

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

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
10/30/2020 Approval of the Shared System 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.

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