Table of contents
This medicine was refused authorisation for use in the European Union.
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.
Questions and answers on the refusal of the marketing authorisation for Onzeald (etirinotecan pegol) (PDF/65.82 KB)Adopted
First published: 21/07/2017
Last updated: 10/11/2017
This EPAR was last updated on 02/02/2018
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Nektar Therapeutics UK Limited
|Date of opinion||
|Date of refusal of marketing authorisation||