EMEA-000520-PIP01-08-M05 - paediatric investigation plan

belimumab
PIPHuman

Key facts

Invented name
  • Benlysta
  • 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
Tel. +44 (0)20 8990 2458

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-000520-PIP01-08-M05
Compliance opinion date
Compliance outcome
Positive

Decision

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