On 20 July 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 Onzeald, intended for the treatment of advanced breast cancer that has spread to the brain. The company that applied for authorisation is Nektar Therapeutics UK Limited. 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 9 November 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
Onzeald
Medicine Name
Onzeald
Aliases
N/ANo risk management plan link.
