Teva Pharmaceutical Industries has received positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for its experimental contraceptive pill, NOMAC-E2 with combination of 1.5mg of 17-beta-estradiol with 2.5mg of nomegestrol acetate in a 24/4 monophasic regimen.
Teva Pharma said that the positive opinion was based on the significant results from the clinical trials evaluating, NOMAC-E2.
NOMAC-E2 is a monophasic regimen containing an estrogen which is structurally identical to the major estrogen produced by the ovaries of healthy non pregnant women, combined with a selective progesterone analogue (nomegestrol acetate).
If approved for marketing by the European Commission, NOMAC-E2 will be marketed by Teva/Theramex in select European markets.
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