On 31 January 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Doxolipad, intended for the treatment of breast and ovarian cancer. The company that applied for authorisation is TLC Biopharmaceuticals B.V.
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 29 May 2019.
Questions and answers on the refusal of the marketing authorisation for Doxolipad (doxorubicin) (PDF/112.87 KB)Adopted
First published: 01/02/2019
Last updated: 26/08/2019
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TLC Biopharmaceuticals B.V.
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