Mylotarg
Refused
gemtuzumab ozogamicin
Medicine
Human
Refused
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.