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
|