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.
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-authorisation applicant |
Wyeth Europa Ltd
|
| Date of opinion |
24/01/2008
|
| Date of refusal of marketing authorisation |
14/04/2008
|
Assessment history
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List item
Mylotarg : EPAR - Refusal public assessment report (PDF/371.18 KB)
First published: 17/04/2008
Last updated: 17/04/2008 -
List item
Questions and answers on the recommendation for the refusal of the marketing authorization for Mylotarg (PDF/35.14 KB)
First published: 24/01/2008
Last updated: 24/01/2008 -