Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
human IgG1 monoclonal antibody specific for human interleukin-1 alpha
Table of contents
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 |
14/09/2017
|
Date of refusal of marketing authorisation |
08/12/2017
|
Assessment history
-
List item
Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech : EPAR - Scientific conclusions and grounds for refusal of the marketing authorisation for Human IGG1 monoclonal antibody specific for human ... (PDF/54.09 KB)
First published: 13/11/2017
Last updated: 13/11/2017 -
List item
Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech : EPAR - Refusal public assessment report (PDF/1.96 MB)
Adopted
First published: 13/11/2017
Last updated: 13/11/2017
EMA/CHMP/552293/2017