Bayer reintroduces Diane-35 onto the French market


WEBWIRE – Thursday, January 16, 2014

Berlin – Following the confirmation of the positive benefit-risk profile by the European Medicines Agency (EMA), Bayer is reintroducing Diane-35 onto the French market in agreement with the French health authority (ANSM). The product had been withdrawn from the French market after a suspension of the marketing authorization as required by the ANSM on May 21st, 2013.

Based on the request of the ANSM at the beginning of 2013, the EMA conducted a review of the benefit-risk profile of Diane-35 and its generics. At the end of July 2013, the EMA concluded that the benefits of Diane-35 outweighed the risks for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. However, when used for acne, Diane-35 should only be used if other treatments, such as those applied to the skin and antibiotics, have failed.

Bayer has collaborated closely with the ANSM in order to ensure a proper handling of the medicine and will continue to do so.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), 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, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 54,900 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.

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