Image by LaMography / Moni Lazar
Hungarian pharmaceutical company Gedeon Richter says the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending approval of its drug RYEQO for the treatment of symptoms of uterine fibroids , according to a State News Wire MTI report.
The European Commission will consider the CHMP recommendation and a final decision on the marketing authorization application is expected in about two months, paving the way for sales of RYEQO in all states of the European Economic Area.
RYEQO contains 40 mg of relugolix, which reduces the amount of estrogen and other hormones produced by the ovaries, 1 mg of estradiol, which may reduce the risk of bone loss, and 0.5 mg of norethisterone acetate, a progestin needed when women with a uterus are taking estrogen. .
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