EMEA-000019-PIP08-12-M03
Key facts
Invented name |
Votubia
|
Active substance |
everolimus
|
Therapeutic area |
Neurology
|
Decision number |
P/0316/2017
|
PIP number |
EMEA-000019-PIP08-12-M03
|
Pharmaceutical form(s) |
|
Condition(s) / indication(s) |
Treatment of tuberous sclerosis complex
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Novartis Europharm Limited
Tel. +41 6132 41111 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000019-PIP08-12-M03
|
Compliance opinion date |
01/06/2018
|
Compliance outcome |
positive
|