Key facts

Invented name
Gazyvaro
Active Substance
Obinutuzumab
Therapeutic area
Oncology
Decision number
P/0196/2021
PIP number
EMEA-001207-PIP01-11-M01
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
  • Treatment of acute lymphoblastic leukaemia
  • Treatment of mature B-cell lymphoma
Route(s) of administration
Intravenous use
Contact for public enquiries

Roche Registration GmbH

E-mail: global.paediatrics@roche.com
Tel. +41 616879411

Decision type
PM: decision on the application for modification of an agreed PIP
Decision date

Decision

P/0196/2021 : EMA decision of 10 May 2021 on the acceptance of a modification of an agreed paediatric investigation plan for obinutuzumab (Gazyvaro), (EMEA-001207-PIP01-11-M01)

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