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
|