EMEA-002042-PIP02-20-M01 - paediatric investigation plan

Erdafitinib

Key facts

• Active substance:
  Erdafitinib
• Therapeutic area:
  Oncology
• Decision number:
  P/0190/2022
• PIP number:
  EMEA-002042-PIP02-20-M01
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate dosage form
• Condition(s) / indication(s):
  Treatment of all conditions included in the category of malignant neoplasms (except urothelial carcinoma, haematopoietic and lymphoid tissue neoplasms)
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  10/06/2022
• Compliance check done:
  No

Decision

P/0190/2022 : EMA decision of 10 June 2022 on the acceptance of a modification of an agreed paediatric investigation plan for erdafitinib (EMEA-002042-PIP02-20-M01)

Reference Number: EMA/251362/2022