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
Contact for public enquiries

Boehringer Ingelheim International GmbH

Tel. +49 6132 778271
Email: Paediatrics@boehringer-ingelheim.com

Decision type
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

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