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
|