EMEA-000311-PIP01-08-M04
Key facts
| Invented name |
Stelara
|
| Active substance |
Ustekinumab
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0003/2016
|
| PIP number |
EMEA-000311-PIP01-08-M04
|
| Pharmaceutical form(s) |
Solution for injection
|
| Condition(s) / indication(s) |
Treatment of chronic plaque psoriasis
|
| Route(s) of administration |
Subcutaneous use
|
| Contact for public enquiries |
Janssen-Cilag International NV
|
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000311-PIP01-08-M04
|
| Compliance opinion date |
29/05/2019
|
| Compliance outcome |
positive
|