EMEA-000832-PIP01-10-M05
Key facts
Invented name |
Tecfidera
|
Active substance |
dimethyl fumarate
|
Therapeutic area |
Neurology
|
Decision number |
P/0177/2020
|
PIP number |
EMEA-000832-PIP01-10-M05
|
Pharmaceutical form(s) |
Capsule, hard
|
Condition(s) / indication(s) |
Treatment of multiple sclerosis
|
Route(s) of administration |
Oral use
|
Contact for public enquiries |
Biogen Idec Ltd
Tel. +01 628501000 |
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000832-PIP01-10-M05
|
Compliance opinion date |
14/06/2021
|
Compliance outcome |
positive
|