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EMEA-001207-PIP05-22 - paediatric investigation plan
Obinutuzumab
PIPHuman
Key facts
Invented name
Gazyvaro
Active Substance
Obinutuzumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0345/2023
PIP number
EMEA-001207-PIP05-22
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of glomerulonephritis and nephrotic syndrome
Route(s) of administration
Intravenous use
Contact for public enquiries
Roche Registration GmbH
global.paediatrics@roche.com +41 616979411
Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
Decision date
Decision
P/0345/2023 : EMA decision of 8 September 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for obinutuzumab (Gazyvaro), (EMEA-001207-PIP05-22)