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Yaz approved in EU

Bayer Schering Pharma has revealed that its contraceptive drug Yaz has been approved for use across all European national markets

Bayer Schering Pharma has revealed that its contraceptive drug Yaz has been approved for use across all European national markets.

The contraceptive pill will be launched in Autumn 2008, the firm has announced. It has been available in the US since 2006 as the only oral contraceptive approved for three indications: contraception, treatment of acne and symptoms of PMDD (premenstrual dysphoric disorder).

"We are absolutely thrilled with the pan-European approval of Yaz, the latest member of our blockbuster drospirenone-based product family," said Dr Philip Smits, head of Bayer Schering Pharma's Business Unit Women's Healthcare. "Yaz offers women an innovative method of contraception with additional benefits, which other oral contraceptives do not have."

PMDD can produce symptoms such as mood swings, irritability, anxiety and headaches. The company hopes to gain approval for the additional indications ñ treatment of PMDD and acne - already in force in the US.

Friederike Lorenzen, spokesperson for Bayer Schering Pharma, said that predicted EU sales of the pill over the next five years are in "the low triple digit million Euro range," according to reports in the Turkish Media.

According to Lorenzen, global sales of Yaz were more than Ä1bn ($1.54bn) in 2007. In February 2008, Bayer Schering Pharma revealed that its portfolio of contraceptive pills - Yasminelle, Yaz and Yasmine - saw an increase in adjusted sales increase of 37 per cent in the same reporting year.

Yaz was approved for use in Holland by Dutch regulatory authorities in July 2007 for both contraceptive and acne treatment indications. The country acted as reference Member State prior to the granting of European-wide marketing authority.

6th May 2008

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