Teva Pharmaceuticals Europe BV, a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd. , and MSD (known as Merck in the United States and Canada) , today announced that ZOELY(TM), a new oral contraceptive (nomegestrol acetate 2.5 mg /17beta-estradiol 1.5 mg), has been granted Marketing Authorization by the European Commission for the prevention of pregnancy in women.
ZOELY is a combined oral contraceptive (COC) tablet containing a unique monophasic combination of two hormones; nomegestrol acetate, a highly selective progesterone-derived progestin and 17beta estradiol, an estrogen that is similar to the one naturally present in a woman's body. This innovative combination will be made available to women in a regimen that contains twenty-four days of active pills and four days of placebo pills. ZOELY is more than 99 percent effective in preventing pregnancy when used as directed.
"The approval of ZOELY further reinforces MSD's longstanding commitment to providing women with greater choice in contraceptive options," said Terrie Curran, general manager and global franchise leader, Women's Health, MSD. "We're delighted to add ZOELY to our robust women's health portfolio through the strong collaborative relationship we have established with our colleagues at Théramex, now a subsidiary of Teva."
"The EU Marketing Authorization for ZOELY marks an important step in creating a strong women's healthcare franchise for Teva in Europe," said Christophe Hubert, vice-president Women's Health Teva Europe and president of Théramex, Teva's Women's Health specialist subsidiary. "The acquisition of Théramex in January this year gives us a platform to leverage our capability in women's healthcare, and the launch of ZOELY is part of our developing business in this area."
The Marketing Authorization of ZOELY applies to all 27 European Union (EU) Member States plus the EEA-EFTA states (Iceland, Liechtenstein and Norway).