Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of Ryeqo (relugolix 40 mg, oestradiol 1.0 mg, and norethisterone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.
The European Commission will review the CHMP recommendation and a final decision on the marketing authorisation application is expected to be available in approximately two months.
The decision will be applicable to all member states of the European Economic Area.
