Mylotarg (gemtuzumab ozogamicin)
Orphan
- Region
- 🇪🇺 EU
- Active substance
- gemtuzumab ozogamicin
- Company
- Wyeth Europa Ltd
- Status
- Refused
- Therapeutic area
- Leukemia, Myeloid, Acute
- CHMP opinion
- Thu 24 Jan 2008
- Designations
- Orphan
- Application
- EMEA/H/C/000705
- ATC
- L01XC05
- Official record
- www.ema.europa.eu
Indication
re-induction treatment of CD33-positive AML adult patients in first relapse who are not candidates for other intensive re-induction chemotherapy regimens (e.g. high-dose Ara-C) and meet at least one of the following criteria: duration of first remission <12 months, or age >60 years.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Mylotarg Authorised · Pfizer Europe MA EEIG
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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.