EMEA-001285-PIP01-12-M02
Key facts
| Invented name |
Unituxin
|
| Active substance |
Dinutuximab
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0208/2013
|
| PIP number |
EMEA-001285-PIP01-12-M02
|
| Pharmaceutical form(s) |
Solution for infusion
|
| Condition(s) / indication(s) |
Treatment of neuroblastoma
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
United Therapeutics Europe Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001285-PIP01-12-M02
|
| Compliance opinion date |
16/12/2016
|
| Compliance outcome |
positive
|