Mylotarg

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gemtuzumab ozogamicin

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

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.

This EPAR was last updated on 23/01/2008

Application details

Product details
Name
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
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

Application details
Marketing-autorisation applicant
Wyeth Europa Ltd
Date of opinion
23/01/2008
Date of refusal of marketing authorisation
13/04/2008

Assessment history

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