On 18 May 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Adlumiz, intended for the treatment of anorexia, cachexia or unintended weight loss in patients with non-small cell lung cancer. The company that applied for authorisation is Helsinn Birex Pharmaceuticals 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 14 September 2017.
Questions and answers on refusal of the marketing authorisation for Adlumiz (anamorelin hydrochloride) (PDF/78.75 KB)Adopted
First published: 19/05/2017
Last updated: 30/11/2017
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11 to 14 September 201715/09/2017