The European Commission will review the CHMP recommendation and a final decision on the marketing authorization application, to be applicable to states in the European Economic Area, is expected "in the coming months".
Ryeqo was cleared by the EMA in July 2021 for treatment of uterine fibroids.
Ryeqo contains 40 mg relugolix, which reduces the amount of estrogen and other hormones produced by the ovaries, 1 mg estradiol, which may reduce the risk of bone loss, and 0.5mg norethisterone acetate, a progestin that is necessary when women with a uterus take estrogen.
Richter's Ryeqo sales came to EUR 6.3 million in H1 2023, the company's latest earnings report shows.
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