EMEA-000265-PIP01-08-M04
Key facts
| Invented name |
Simponi
|
| Active substance |
Golimumab
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0226/2014
|
| PIP number |
EMEA-000265-PIP01-08-M04
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of chronic idiopathic arthritis (including rheumatoid arthritis, psoriatic arthritis, spondylarthritis and juvenile idiopathic arthritis)
|
| Route(s) of administration |
|
| Contact for public enquiries |
Janssen Biologics B.V.
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000265-PIP01-08-M04
|
| Compliance opinion date |
10/10/2014
|
| Compliance outcome |
positive
|