EMEA-001596-PIP02-17-M02 - paediatric investigation plan

afatinib

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
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  13/05/2020
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001596-PIP02-17-M02
• Compliance opinion date:
  23/04/2021
• 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)

Reference Number: EMA/233269/2020