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
|