New oral contraceptive regimen submitted for marketing authorization in the EU
For use outside the US only
Will support women in managing their menstrual cycle individually / Minimizes the number of bleedings / Innovative device, supporting women to follow an individualized intake regimen
Berlin, – Bayer HealthCare has submitted an application for marketing authorization in Europe for a new innovative oral contraceptive regimen based on YAZ® (ethinylestradiol/drospirenone) which enables women to manage their periods individually. The submission is based on positive data of an international Phase III study programme, which will be presented in due time at a scientific meeting. The Netherlands will serve as the reference member state in the decentralized procedure for gaining marketing authorization in European countries. Once approved, this new concept will enable women to schedule their periods flexibly according to their personal needs, while at the same time reducing the overall number of bleeding episodes per year. It is planned to supply the new product with an innovative tablet dispensing device which assists women in flexibly planning their cycles and which is also designed to support their intake regimen.
“Many women are interested in managing their menstrual cycle individually, and are looking for a way to minimize the number of bleedings. With our new contraceptive regimen we will address this need in addition to providing reliable contraception. Our clinical studies have shown that this new regimen enables women to individually adapt their cycle length and to have a maximum period-free interval of up to 120 days,” said Dr. Flemming Oernskov, Head of Women’s Healthcare & General Medicine at Bayer Healthcare.
The new regimen involves a daily intake for a minimum period of 24 days and up to a maximum period of 120 days. During this interval (day 25 to 120) women can schedule the 4-day tablet-free interval individually. A new cycle begins after each tablet-free interval. It has been shown that fewer bleeding episodes per year can help to reduce menstrual symptoms.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of more than EUR 15.9 billion (2009), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 53.400 employees and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.
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