EMEA-000290-PIP01-08-M04
Key facts
| Invented name |
Tasigna
|
| Active substance |
nilotinib
|
| Therapeutic area |
Oncology
|
| Decision number |
P/0297/2015
|
| PIP number |
EMEA-000290-PIP01-08-M04
|
| Pharmaceutical form(s) |
Capsule, hard
|
| Condition(s) / indication(s) |
Treatment of chronic myeloid leukaemia
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Novartis Europharm Limited
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000290-PIP01-08-M04
|
| Compliance opinion date |
11/11/2016
|
| Compliance outcome |
positive
|