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EMEA-001596-PIP02-17-M02 - paediatric investigation plan
afatinib
PIPHuman
Key facts
Invented name
Giotrif
Active Substance
afatinib
Therapeutic area
Oncology
Decision number
P/0184/2020
PIP number
EMEA-001596-PIP02-17-M02
Pharmaceutical form(s)
Oral use
Condition(s) / indication(s)
Treatment of all conditions included in the category of malignant neoplasms (excluding central nervous system, haematopoietic and lymphoid tissue neoplasms)
Treatment of malignant neoplasms of the central nervous system
PM: decision on the application for modification of an agreed PIP
Decision date
Compliance procedure number
EMEA-C-001596-PIP02-17-M02
Compliance opinion date
Compliance outcome
Positive
Decision
P/0184/2020: EMA decision of 13 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for afatinib (Giotrif), (EMEA-001596-PIP02-17-M02)