EMEA-000520-PIP01-08-M05
Key facts
| Invented name |
Benlysta
|
| Active substance |
belimumab
|
| Therapeutic area |
Immunology-Rheumatology-Transplantation
|
| Decision number |
P/0183/2016
|
| PIP number |
EMEA-000520-PIP01-08-M05
|
| Pharmaceutical form(s) |
Powder for concentrate for solution for infusion
|
| Condition(s) / indication(s) |
Treatment of Systemic Lupus Erythematosus (SLE)
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Glaxo Group Limited
E-mail: eu.paediatrics-plans@gsk.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-000520-PIP01-08-M05
|
| Compliance opinion date |
16/11/2018
|
| Compliance outcome |
positive
|