Organon (NYSE: OGN), a global health-care company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the MIUDELLA® (copper intrauterine system) Risk Evaluation and Mitigation Strategy (REMS) Program is now open for enrollment at www.miudellarems.com. The website enables healthcare providers, healthcare settings, and eligible specialty pharmacies to complete the certification and enrollment activities required to support the dispensing and insertion of MIUDELLA.
MIUDELLA is a hormone-free, copper intrauterine device (IUD) indicated for the prevention of pregnancy in females of reproductive potential for up to three years. The purpose of the MIUDELLA REMS is to mitigate the risk of complications due to the improper insertion of MIUDELLA by untrained healthcare providers.
Two certifications are required before MIUDELLA can be dispensed for insertion:
• Individual healthcare provider certification
• Separate healthcare setting certification
Healthcare providers who plan to insert MIUDELLA must individually complete REMS training and certification at www.miudellarems.com. Once certified, providers can manage affiliated healthcare settings through the HCP portal.
This morning’s news release concludes by saying, “a separate, independent certification is required for all practices and healthcare settings that purchase, dispense, or administer MIUDELLA, even if an individual provider at that setting is already certified. An authorized representative must complete the enrollment form and train all staff involved in dispensing on the REMS requirements.”
OGN shares nicked ahead 0.5 cents to $13.62.
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