Doxolipad

doxorubicin hydrochloride

Opinion

Update of 1 March 2019:

The applicant for Doxolipad has requested a re-examination of the CHMP’s January 2019 opinion. Upon receipt of the grounds of the request, the CHMP will re-examine its opinion and issue a final recommendation.

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. It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.

Key facts

Name
Doxolipad
Agency product number
EMEA/H/C/004110
International non-proprietary name (INN) or common name
  • doxorubicin hydrochloride
Active substance
  • doxorubicin hydrochloride
Therapeutic area
Breast Neoplasms
Ovarian Neoplasms
Date opinion adopted
31/01/2019
Company name
TLC Biopharmaceuticals B.V.
Status
Negative
Application type
Initial authorisation

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