Doxolipad

doxorubicin

Opinion

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.

Key facts

Name
Doxolipad
Agency product number
EMEA/H/C/004110
International non-proprietary name (INN) or common name
  • doxorubicin
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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