Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech

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human IgG1 monoclonal antibody specific for human interleukin-1 alpha

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 medicine ‘Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech’, intended for intended for treating debilitating symptoms of advanced colorectal cancer. The company that applied for authorisation is XBiotech Germany GmbH.

The company requested a re-examination of the opinion. After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 14 September 2017.

This EPAR was last updated on 13/11/2017

Application details

Product details
Name
Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
Active substance
human IgG1 monoclonal antibody specific for human interleukin-1 alpha
International non-proprietary name (INN) or common name
human IgG1 monoclonal antibody specific for human interleukin-1 alpha
Therapeutic area (MeSH)
Colorectal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01
Application details
Marketing-authorisation applicant
XBiotech Germany GmbH
Date of opinion
18/05/2017
Date of refusal of marketing authorisation
14/09/2017

Assessment history

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