Mylotarg (gemtuzumab ozogamicin)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- gemtuzumab ozogamicin
- Company
- Pfizer Europe MA EEIG
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 22 Feb 2018
- EU approval
- Thu 19 Apr 2018
- Designations
- Orphan
- Application
- EMEA/H/C/004204
- Official record
- www.ema.europa.eu
Indication
Mylotarg is indicated for combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of patients age 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia (APL).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mylotarg Refused · Wyeth Europa Ltd
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.