Zoely, a monophasic combination of 2 steroid hormones – 17-beta estradiol and nomegestrol acetate, will be made available in a convenient 24 day active and 4 day placebo dosing regimen.
Teva expects to launch Zoely in 2011.
Teva Europe president and CEO Gerard van Odijk said the EU marketing authorization for Zoely marks an important step in creating a strong women’s healthcare franchise for Teva in Europe.
"The acquisition of Theramex in January this year gives them a platform to leverage their capability in women’s healthcare, and the launch of Zoely is part of the developing business in this area," Odijk said.