EMEA-003044-PIP01-21
Key facts
| Active substance |
Anti-CD123 IgG1 humanised monoclonal antibody conjugated to N1-(2-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)ethyl)-N6-((S)-1-(((S)-1-((3-((((S)-8-methoxy-6-oxo-11,12,12a,13-tetrahydro-6H-benzo[5,6][1,4]diazepino[1,2-a]indol-9-yl)oxy)methyl)-5-((((S)-8-methoxy-6-oxo-12a,13-dihydro-6Hbenzo[5,6][1,4]diazepino[1,2-a]indol-9-yl)oxy)methyl)phenyl)amino)-1-oxopropan-2-yl)amino)-1-oxopropan-2-yl)adipamide
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0425/2021
|
| PIP number |
EMEA-003044-PIP01-21
|
| Pharmaceutical form(s) |
All pharmaceutical forms
|
| Condition(s) / indication(s) |
Treatment of blastic plasmacytoid dendritic cell neoplasm
|
| Route(s) of administration |
All routes of administration
|
| Contact for public enquiries |
Immunogen BioPharma (Ireland) Limited
Email: regulatory.affairs@immunogen.com |
| Decision type |
W: decision granting a waiver in all age groups for all conditions or indications
|