Tibelia®, First Tibolone-Based Hormone Therapy Approved in Canada - 15 May
The Canadian Health authorities have granted the Marketing Authorization for Tibelia®, the company’s tibolone-based product for use in Hormone Therapy (HT).
•First tibolone-based hormone treatment to be available in Canada, offering a true new option for women with a proven efficacy, tolerability and safety profile
•The introduction of Tibelia® in Canada plays a crucial role in the international commercial expansion strategy in key attractive markets like the United States
Liege, Belgium, 15 May 2019 – 7 :30 CEST – Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health today announces that Health Canada, the Canadian Health authorities, has approved Tibelia® (tibolone), indicated for the short-term treatment of vasomotor symptoms due to estrogen deficiency in postmenopausal women, more than one year after menopause. Developed by Mithra as bioequivalent version of Livial®, Tibelia® is a synthetic steroid that relieves postmenopausal symptoms and prevents osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products.