Doxolipad

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doxorubicin

Refused
This medicine was refused authorisation for use in the European Union.

Overview

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.
 

This EPAR was last updated on 26/08/2019

Application details

Product details
Name
Doxolipad
Active substance
doxorubicin hydrochloride
International non-proprietary name (INN) or common name
doxorubicin
Therapeutic area (MeSH)
  • Breast Neoplasms
  • Ovarian Neoplasms
Anatomical therapeutic chemical (ATC) code
L01DB01
Application details
Marketing-authorisation applicant
TLC Biopharmaceuticals B.V.
Date of opinion
29/05/2019
Date of refusal of marketing authorisation
08/08/2019

Assessment history

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