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
|