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What is Ryeqo Risk Management Summary about?

This document summarizes the risk management plan for Ryeqo, which contains relugolix, estradiol, and norethisterone acetate and is used to treat moderate to severe symptoms of uterine fibroids. Potential risks include loss of bone mineral density, though clinical trials found no meaningful difference compared to placebo, and embryo-fetal toxicity seen in animal studies. No important identified risks were found. The risk management plan outlines routine risk minimization measures like warnings in labeli

Author

Umaima faiz

Language

EN