Indications
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).
Composition
- Active substance
- gemtuzumab ozogamicin
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Medicine
- Mylotarg
- Active substance
- gemtuzumab ozogamicin
- Therapeutic area
- Leukemia, Myeloid, Acute
- Marketing authorisation holder
- Pfizer Europe MA EEIG
- Status
- Authorised
- EU authorisation
- 19 Apr 2018
- EMA product number
- EMEA/H/C/004204
EMA designations
- Orphan medicine
- Yes
- Conditional approval
- No
- Biosimilar
- No
- Generic
- No
- Accelerated assessment
- No
- Additional monitoring
- No
- Patient safety information
- No