EMEA-001095-PIP02-12
Key facts
Invented name |
Tysabri
|
Active substance |
natalizumab
|
Therapeutic area |
Neurology
|
Decision number |
P/0252/2012
|
PIP number |
EMEA-001095-PIP02-12
|
Pharmaceutical form(s) |
Concentrate for solution for infusion
|
Condition(s) / indication(s) |
Treatment of multiple sclerosis
|
Route(s) of administration |
Intravenous use
|
Contact for public enquiries |
Biogen Idec Limited
|
Decision type |
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
|
Compliance procedure number |
EMEA-C-001095-PIP02-12
|
Compliance opinion date |
16/12/2016
|
Compliance outcome |
positive
|