EMEA-000309-PIP01-08-M07
Key facts
Invented name |
RoActemra
|
Active substance |
tocilizumab
|
Therapeutic area |
Immunology-Rheumatology-Transplantation
|
Decision number |
P/0266/2015
|
PIP number |
EMEA-000309-PIP01-08-M07
|
Pharmaceutical form(s) |
Concentrate for solution for infusion
|
Condition(s) / indication(s) |
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and juvenile idiopathic arthritis)
|
Route(s) of administration |
|
Contact for public enquiries |
Roche Registration Limited
|
Decision type |
PM: decision on the application for modification of an agreed PIP
|
Compliance procedure number |
EMEA-C-000309-PIP01-08-M07
|
Compliance opinion date |
23/02/2018
|
Compliance outcome |
positive
|