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

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