French nod is latest approval for Mithra's Livial generic

30 May 2017

Women’s health specialist Mithra (Euronext Brussels: MITRA) has received a Marketing Authorization (MA) for the commercialization of Tibelia (tibolone), a generic version of Livial, in France.

This means that the Belgian company has now been given the go-ahead to market Tibelia in 15 European countries. It is already available in the UK, Spain, and the Netherlands, through existing supply and license deals signed in 2016, with launches in Italy, Finland and Sweden expected in coming months. Mithra expects to sign further agreements, including in France, in 2017.

Tibelia is a copy of a drug originally developed by US pharma giant Merck & Co (NYSE: MRK). It is a synthetic steroid for use in hormone replacement therapy. This includes the relief of postmenopausal symptoms, in addition to prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products.

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