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EMEA-001638-PIP01-14-M02 - paediatric investigation plan
atezolizumab
PIPHuman
Key facts
Invented name
Tecentriq
Active Substance
atezolizumab
Therapeutic area
Oncology
Decision number
P/0207/2019
PIP number
EMEA-001638-PIP01-14-M02
Pharmaceutical form(s)
Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (except central nervous system tumours, haematopoietic and lymphoid tissue neoplasms)
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001638-PIP01-14-M02
Compliance opinion date
Compliance outcome
Positive
Decision
P/0207/2019: EMA decision of 12 June 2019 on the acceptance of a modification of an agreed paediatric investigation plan for atezolizumab (Tecentriq), (EMEA-001638-PIP01-14-M02)
Public summary of the evaluation of a proposed product-specific waiver: Anti programmed death-ligand 1 (PD-L1) monoclonal antibody (MPDL3280A) for treatment of all conditions included in the category of malignant neoplas...