Adlumiz

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anamorelin

Refused
This medicine was refused authorisation for use in the European Union.

Overview

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.

This EPAR was last updated on 30/11/2017

Application details

Product details
Name
Adlumiz
Active substance
anamorelin hydrochloride
International non-proprietary name (INN) or common name
anamorelin
Therapeutic area (MeSH)
  • Cachexia
  • Anorexia
  • Carcinoma, Non-Small-Cell Lung
Anatomical therapeutic chemical (ATC) code
V03
Application details
Date of opinion
14/09/2017
Date of refusal of marketing authorisation
16/11/2017

Assessment history

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