EMEA-000087-PIP01-07-M05
Key facts
Invented name |
Gilenya
|
Active substance |
fingolimod hydrochloride
|
Therapeutic area |
Neurology
|
Decision number |
P/0050/2017
|
PIP number |
EMEA-000087-PIP01-07-M05
|
Pharmaceutical form(s) |
Capsule, hard
|
Condition(s) / indication(s) |
Treatment of multiple sclerosis
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Novartis Europharm Limited
Tel. +41 613241111 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000087-PIP01-07-M05
|
Compliance opinion date |
10/11/2017
|
Compliance outcome |
positive
|