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\.
Therapeutic Indication
N/A
Therapeutic Area (MeSH)
ATC Code
L01
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
EMA Name
Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
Medicine Name
Human IGG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech
Aliases
N/ANo risk management plan link.