Mylotarg

Refused

This medicine has been refused authorisation

gemtuzumab ozogamicin

Overview

On 20 September 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Mylotarg 5 mg powder for solution for infusion, intended for the treatment of acute myeloid leukaemia. The company that applied for authorisation is Wyeth Europa Ltd. The applicant requested a re-examination of the opin ion. After having considered the grounds for this request, the CHMP re-examined the initial opinion , and confirmed the refusal of the marketing authorisation on 24 January 2008.

Questions and answers on the recommendation for the refusal of the marketing authorization for Mylotarg

Product details

• Name of medicine:
  Mylotarg
• Active substance:
  gemtuzumab ozogamicin
• International non-proprietary name (INN) or common name:
  gemtuzumab ozogamicin
• Therapeutic area (MeSH):
  Leukemia, Myeloid, Acute
• Anatomical therapeutic chemical (ATC) code:
  L01XC05

Pharmacotherapeutic group

Antineoplastic agents

Application details

• EMA product number:
  EMEA/H/C/000705
• Orphan:

  This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

• Marketing authorisation applicant:
  Wyeth Europa Ltd
• Opinion adopted:
  24/01/2008
• Refusal of marketing authorisation:
  14/04/2008

Assessment history

Mylotarg : EPAR - Refusal public assessment report