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) |
hard capsule
|
| 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
|