On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Eladynos, intended for the treatment of osteoporosis (a disease that makes bones fragile). The company that applied for authorisation is Radius International Ltd.
The company requested a re‑examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the marketing authorisation on 26 July 2018.
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Radius Health Ireland Ltd
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