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EU approval for Teva's contraceptive Zoely

Teva's new combined oral contraceptive Zoely has gained approval from the European Medicines Agency (EMA) for launch in the EU

Teva Pharmaceutical Industries gained approval today from the European Medicines Agency (EMA) for the launch of its new oral contraceptive, Zoely (nomegestrol acetate).

The drug is a combined oral contraceptive (COC), and once launched, will be available in a 24 day active and 4 day placebo dosing regimen. It is approved for use in the EU.

The EMA's Committee for Medicinal Products for Human Use (CHMP) recommended the drug in March, 2011, stating that there is a "favourable benefit to risk balance for Zoely." The CHMP is an advisory body to the EMA.

The approval of Zoely covers the 27 EU member States as well as Norway, Iceland and Liechtenstein, with Teva holding the exclusive marketing rights in France, Belgium and Spain. The first launch of Zoely is expected before the end of 2011.

2nd August 2011


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