Bayer Schering Pharma submits Visanne for registration in Europe

Published: 7-Jan-2009
Regulatory

Bayer Schering Pharma, Germany has submitted Visanne for the treatment of endometriosis for registration in Europe.


Bayer Schering Pharma, Germany has submitted Visanne for the treatment of endometriosis for registration in Europe.

The Netherlands will serve as the reference member state for the decentralised procedure to receive European-wide marketing authorisation.

Visanne contains 2mg of Dienogest and is administered orally once a day. In contrast to other drugs used for the treatment of this chronic gynecological disease, Visanne is for the long-term treatment of endometriosis. The current standard-therapy with GnRH analogue is only effective for short-term treatment due to severe side-effects such as decreased bone mineral density and hot flushes, the company said.

Phil Smits, head of Bayer Schering Pharma's Women's Healthcare business unit, said: "With the submission of Visanne we have reached another important strategic milestone in the development of innovative gynecological products geared towards improving women's health."

He added that as endometriosis is a long-lasting gynaecological condition that causes dramatic and recurrent pain, there is a need for an effective and well-tolerated treatment that can be used over a long period of time.

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