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
|