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
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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 agentsAssessment history
Mylotarg : EPAR - Refusal public assessment report
English (EN)
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