EMEA-000555-PIP01-09-M06
Key facts
| Invented name |
Dacogen
|
| Active substance |
Decitabine
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0234/2017
|
| PIP number |
EMEA-000555-PIP01-09-M06
|
| Pharmaceutical form(s) |
Powder for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of acute myeloid leukaemia
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Janssen-Cilag International NV
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000555-PIP01-09-M06
|
| Compliance opinion date |
18/10/2019
|
| Compliance outcome |
positive
|