EMEA-001207-PIP06-22 - paediatric investigation plan

Obinutuzumab
PIPHuman

Key facts

Invented name
Gazyvaro
Active Substance
Obinutuzumab
Therapeutic area
Oncology
Decision number
P/0502/2022
PIP number
EMEA-001207-PIP06-22
Pharmaceutical form(s)
Concentrate and solvent for concentrate for solution for infusion
Condition(s) / indication(s)
Prevention of cytokine release syndrome induced by anti CD20/CD3 antibodies
Route(s) of administration
Intravenous use
Contact for public enquiries

Roche Registration GmbH

Tel. +41 6169 79411
E-mail: global.paediatrics@roche.com

Decision type
P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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